Supplementation Group Research Articles

The efficacy of evening primrose seed oil supplements on ART outcomes: A triple-blinded randomized placebo-controlled clinical trial

BackgroundEvening primrose oil (EPO) has been extensively documented for its potential benefits in various medical conditions, including gestational diabetes, inflammatory diseases, cyclic breast pain, cancer, premenstrual syndrome, menopausal syndrome, and female reproductive disorders. ObjectivesThe aim of this study was to investigate the impact of evening primrose oil (EPO) supplementation on the outcomes of assisted reproductive technology (ART). MethodsA randomized, triple-blinded, placebo-controlled clinical trial was conducted. A total of 84 infertile women who were candidates for intracytoplasmic sperm injection (ICSI) were randomly assigned to either the EPO supplementation group or the placebo (p) group with a 1:1 ratio. The EPO capsule was given from day 1–2 of the ART cycle at a dosage of 1000 mg every eight hours for two weeks. Finally, the ART outcomes parameters as well as the treatment side effects were evaluated. ResultsThe results illustrated no statistically significant disparities between the groups in terms of the number of oocytes retrieved, ovarian sensitivity index (OSI), rate of fertilization, and number and quality of embryos (p>0.05). However, a notably enhanced incidence of pregnancy and implantation rates in the EPO group was observed when compared to the P group (42.9 % vs. 17.4 % and 23±30.5 % vs. 10.87±26 %, respectively). Moreover, none of the patients experienced side effects from the intervention. ConclusionsEPO consumption for two weeks could improve ART outcomes by increasing implantation and pregnancy rates without significantly affecting the number of mature oocytes, rate of fertilization, and the quantity and quality of embryos. These findings highlight the significance of a maternal preconception diet.

Impact of oral melatonin supplementation on urine and serum melatonin concentrations and quality-of-life measures in persons with relapsing multiple sclerosis

IntroductionMelatonin is an antioxidant and anti-inflammatory agent that modulates the immune system by scavenging free radicals, reducing the upregulation of pro-inflammatory cytokines, and reducing transendothelial cell migration. Therefore, melatonin may play a role in regulating multiple sclerosis (MS) disease activity. However, little is known about how melatonin supplementation effects individuals with MS. ObjectiveDetermine if there was a dose-dependent elevation in urine and serum melatonin concentrations. Determine if melatonin supplementation had an impact on patient reported outcomes. MethodsThis was a randomized, dose-blinded exploratory study. Adults (age 18–65) with relapsing forms of multiple sclerosis (RMS) treated with a stable dose of oral disease modifying therapy for at least 6 months were randomized into melatonin 3 mg or 5 mg daily. Urinary and serum melatonin levels and modified fatigue impact scale (MFIS), multiple sclerosis impact scale (MSIS-29), and Pittsburgh sleep quality index (PSQI), patient determined disease steps (PDDS) and performance scales (PS) were measured at baseline, 3, 6, and 12 months. Urinary and serum melatonin analyses was performed to estimate mean concentrations and their differences between treatment arms over time by a repeated measures linear mixed model. The model included treatment, assessment time, and treatment × time interaction. ResultsThirty patients, randomized 1:1, were analyzed in an intent to treat population. Twenty-three completed the study. The repeated measures linear mixed model analysis of all timepoints revealed higher melatonin concentrations in patients on 5 mg compared to 3 mg melatonin for both urinary 6-SMT (p = 0.03) and serum melatonin (p = 0.04). MFIS, MSIS-29, PSQI, and PDSS-PS scores did not significantly change from baseline to month 12. No significant differences in these measures were seen between the two doses. Five patients stopped melatonin (three on 5 mg and two on 3 mg) due to adverse events, including one patient who developed focal spongiotic dermatitis. One patient experienced three consecutive serious adverse events that were unrelated to melatonin supplementation. ConclusionsThe 5 mg melatonin supplementation group had higher concentrations of urinary 6-SMT and serum melatonin compared to the 3 mg group over 12 months of treatment. There was a correlation between 6-SMT and serum melatonin concentrations. This suggests that measuring serum melatonin is a reliable alternative to measuring urinary 6-SMT. However, no differences in clinical benefit between the two dosage groups were demonstrated in the patient reported outcomes. Trial Registration NumberNCT03498131

Investigation of the Physiological and Post‐training Effects of Ecdysteroid Supplementation by Multivariate Analysis of the Human Serum Metabolome

ABSTRACTThis work aims to characterize the serum profile of athletes after the administration of ecdysteroids, natural steroid hormones recently reported to enhance athletic performance. The combination of mass spectrometry and chemometric tools may allow to differentiate physiological effects from post‐training and intake‐driven effects. Serum samples were collected from 46 healthy male volunteers and divided into four groups: control (two capsules/day of Peak Ecdysone without training), placebo (two capsules without ecdysteroids with training), Ec1 (two capsules/day Peak Ecdysone with training), and Ec2 (eight capsules/day Peak Ecdysone with training). Metabolic profiling was measured using a SCIEX Triple Quadrupole LC‐MS/MS system coupled with the Biocrates AbsoluteIDQ p180 kit, which allows quantitation of a large panel of metabolites that were subjected to multivariate analysis. Unsupervised analysis of the data found no significant differences between the placebo and the ecdysteroid supplementation groups. By merging Ec1 and Ec2 into a single group, coded as treated, a clear discrimination between the control and placebo groups was observed. Phosphatidylcholines were among the most significant features of ecdysteroids administration, showing a dose‐dependent effect in Ec1 and Ec2 groups. As specific metabolic phenotypes can result from years of training, the discrimination of physiological effects from those caused by the administration of banned substances can be a valuable analytical strategy for the interpretation of adverse analytical findings in the anti‐doping field.

Compound Bacillus improves eggshell quality and egg metabolites of hens by promoting the metabolism balance of calcium and phosphorus and uterine cell proliferation

Probiotics have beneficial effects on improving egg quality, but there is little research about the effect of probiotics on metabolite composition, and the mechanisms are not yet fully understood. The aim of this study was to investigate the potential mechanisms by which compound Bacillus improves egg quality and metabolite composition. A total of 20,000 Jingfen No. 6 laying hens at 381 d old were randomly divided into two treatments: control group with a basal diet, and the basal diet with compound Bacillus supplementation (Ba) group. The trial lasted eight weeks. The results showed that compound Bacillus improved the gloss and strength of eggshells and reduced the ratio of sand-shell eggs by 23.8%. Specifically, the effective layer of eggshell was thicker and its calcite column was closely connected. Compound Bacillus increased the contents of beneficial fatty acids in the egg yolk, and lipids and lipid-like molecules in the albumen (P < 0.01), while decreased the contents of total cholesterol, triglycerides, and benzene ring compounds in the egg yolk and organic oxygen compounds in the albumen (P < 0.01). In addition, the compound Bacillus increased the calcium absorption in the duodenum by up-regulating the expression of transporters and serum hormone synergism (P < 0.05), and promoted metabolic balance of calcium and phosphorus. Simultaneously, uterine transcriptome showed that the expression of ChaC glutathione specific gamma-glutamylcyclotransferase 1 (CHAC1), glycoprotein-N-acetylgalactosamine 3-beta-galactosyltransferase 1 (C1GALT1), phosphatidylinositol-4-phosphate 5-kinase type 1 beta (PIP5K1B), methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), brain enriched myelin associated protein 1 (BCAS1), and squalene epoxidase (SQLE) genes were increased (P < 0.01), indicating that nutrient metabolism activity was enhanced. The expression of the BCAS1, C1GALT1, KLF transcription factor 13 (KLF13), and leucine rich repeat neuronal 1 (LRRN1) was increased (P < 0.01), indicating that the cell proliferation was enhanced, which slowed uterus aging. In conclusion, compound Bacillus improved the eggshell strength and metabolite composition in the egg by promoting metabolic balance of calcium and phosphorus, cell proliferation, and nutrient metabolism in the uterus.

Maternal chromium supplementation improves oxidation resistance, immunity, and intestinal morphology of goat kids injected with lipopolysaccharide

This study evaluated the effects of maternal chromium (Cr), supplemented with Cr propionate (CrPro) during perinatal period of does, on antioxidant capacity, immune response, and intestinal morphology of goat kids injected with lipopolysaccharide (LPS). Forty LeZhi black does at 90 days of pregnancy were divided into four groups based on body weight (52.36±8.24 kg) with 10 replicate pens for each treatment and one doe for each replicate pen. Treatments consisted of 0, 0.4, 1.2, or 2.0 mg of supplemental Cr per head per day (head-1 d-1) from CrPro. After birth, the goat kids were allowed to suckle until 21 days. At 21-day-old, one male goat kid per replicate was sacrificed 2 h after LPS injection. Individual weight and litter weight of goat kids on birth and 21 d were not affected by maternal Cr supplementation. Chromium concentrations in umbilical cord, colostrum and liver of goat kids were linearly increased by maternal Cr supplementation (P<0.05). Maternal Cr supplementation quadratically increased serum total superoxide dismutase (T-SOD) activity of goat kids (P<0.05). Goat kids from maternal Cr supplementation groups had higher serum T-SOD activity than those from control group (P<0.05). Serum malondialdehyde (MDA) concentration of goat kids was linearly decreased, whereas serum glutathione peroxidase (GSH-Px) activity was linearly increased as maternal Cr increased (P<0.05). Maternal Cr supplementation linearly increased colostrum immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) concentrations (P<0.05), and quadratically increased serum IgG and IgM concentration of goat kids with the greatest response detected at 0.4 mg head-1 d-1 maternal Cr supplementation group (P<0.05). The villus height (VH) and the ratio of villus height to crypt depth (V/C) in duodenum of goat kids increased quadratically as maternal Cr increased, and both reached the highest in maternal 1.2 mg head-1 d-1 maternal Cr supplementation group. Maternal Cr supplementation linearly decreased ileal crypt depth (CD) of goat kids. The results indicate that 0.4-2.0 mg (0.47-2.41 mg by analysis) head-1 d-1 maternal Cr supplementation from CrPro could improve antioxidant capacity, immune response, and small intestinal morphology of goat kids injected with LPS.

Effects of MIND diet and propolis supplementation on metabolic syndrome indices and cognitive function among patients with metabolic syndrome in Isfahan, Iran, 2024. A rationale and study protocol for randomized controlled trial.

Metabolic syndrome (MetS) is the main general and clinical health challenge worldwide. Based on the National Cholesterol Education Program, if the person has three or more indices containing: elevated fasting blood sugar, high levels of triglycerides, hypertension, low levels of high-density lipoprotein cholesterol, and central obesity, he suffers MetS. The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay diet is a novel diet that with the specific aim of safeguarding cognitive function. Propolis is a resinous substance produced by bees from the combination of buds and secretions of plants with saliva and bee enzymes. After propolis supplementation, a significant reduction in fasting plasma glucose levels and lipid profiles has been observed. Considering the importance of chronic diseases like MetS on health, the role of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and propolis supplement that will improve blood sugar, blood lipid, anthropometric indicators, blood pressure, and cognitive function, and limited contradictory studies, we decided to conduct this study. This study, which is a randomized controlled clinical trial study, will be conducted on adults with MetS who will visit Hazrat Ali Health Center in Isfahan. Participants must provide informed consent before engaging in the study. Demographic data such as age, gender, and medical history will be recorded. Then, anthropometric indices, MetS indices, and cognitive function will be measured in all subjects. The study participants will be divided into three groups and will be controlled for 12 weeks. We will have a MIND diet + placebo group, a MIND diet + propolis supplement group, and a control group that will receive a microcrystalline cellulose placebo and usual dietary advice. At the end of the intervention, all indices will be assessed again. The data obtained in the study will be analyzed at descriptive and analytical levels by the statistical software SPSS26. The present study's protocol was approved by the Iranian Registry of Clinical Trials (www.irct.ir) on 3/28/2023 and a registration reference is IRCT20230105057054N1.

The effect of dietary supplementation of Lycium barbarum leaves on the growth performance, organ indexes and intestinal microflora of rats.

This study was conducted to investigate both fruit and different levels of leaf supplementation on the growth performance, organ indices and intestinal microflora of rats. Twenty-five healthy male Sprague-Dawley rats were randomly divided into five groups. The rats in the control (NC) and positive control (PC) groups were fed by gavage a basal diet and a basal diet with 4 g/kg of L. barbarum fruit homogenate, respectively. The test (LD, MD, and HD) groups were fed basal diets with additional 2, 4, and 8 g/kg of L. barbarum leaf homogenate, respectively. The feeding period was 35 d. The result revealed that the rats in the LD group had the highest average weight gain (p < 0.05). The cardiac and renal indexes in the LD and MD groups were significantly higher than in NC group, respectively (p < 0.05). Diversity analysis revealed that adding low concentrations of L. barbarum leaf homogenates markedly reduced the Shannon index of the rats cecum (p < 0.05). The relative abundance of Verrucomicrobiota was higher in the LD group than those in other groups (p < 0.05). The relative abundance of Actinobacteriota was found significantly higher in PC group than others (p < 0.05). The relative abundance of Akkermansia in LD group was the highest (p < 0.05). The relative abundance of Romboutsia in the PC group was considerably higher than that in other groups. The relative abundance of Candidatus_Saccharimonas in the supplementation groups was appreciably lower than those found in other groups. The relative abundance of Alloprevotella was significantly lower in PC, LD, and MD groups than in NC and HD groups (p < 0.05). The relative abundance of Oscillibacter was significantly higher in HD group than in other groups (p < 0.05). Thus, L. barbarum leaf homogenate fed to rats could increase their growth performance, internal organ weights and additionally enhance the relative abundance of beneficial bacteria. Therefore, based on the obtained data in the current study, a dose of L. barbarum leaf homogenate supplemented with 2 g/kg in diet is recommended, however, further studies are required to confirm, especially in animals.

Effect of Resistance Training with Coenzyme Q10 Supplementation on the Intracellular Content of NRF2 and NQO1 Proteins in the Hippocampal Tissue of Male Sprague-Dawley Rats

Introduction: NRF2 and NQO1 proteins are very important for cell protection; Therefore, the purpose of this research was investigating the effect of resistance training with coenzyme Q10 supplementation on the content of NRF2 and NQO1 proteins in the hippocampus of male Sprague-Dawley rats. Methods: In this experimental study, thirty-two 2-month-old Sprague-Dawley rats with an average weight of 200±20 gr were selected. Rats were randomly divided into four groups: 1-control, 2-resistance training, 3-resistance training+Q10 supplement and 4-Q10 supplement. The resistance training program consisted of climbing a ladder with 26 steps and a slope of 85 degrees, for 8 weeks and 3 sessions every week. The daily consumption of Q10 supplement was 200 mg/kg of body weight of rats. The content of proteins was measured through Western-Blot laboratory method. Data analysis was done by one-way ANOVA and Tukey's post hoc tests and the effect size of eta squared test using SPSS version 16 and Graphpad Prism software version 10.2.3. The significance level was P≤0.05. Results: Eight weeks of resistance training with Q10 supplementation led to a significant change in NRF2 content (F=4.80, p≤0.03, ƞ2=0.64). Tukey's post hoc test showed this significant change between pairs of resistance training groups and Q10 supplement group (p≤0.04); medium effect size was observed in NRF2 content (ƞ2=0.64). No significant difference was observed in NQO1 content (F=3.01, p≤0.09, ƞ2=0.33). A weak effect size was observed in NQO1 content (ƞ2=0.33). Conclusion: Doing resistance training together with Q10 supplementation alone or in combination cannot significantly change the content of NRF2 and NQO1 proteins in the hippocampus of the brain.

The Preventive Efficacy of Selenium Supplements on Muscle Soreness Post Heavy Eccentric Exercise

Delayed Onset Muscle Soreness (DOMS) is the muscle pain and stiffness following unaccustomed or strenuous physical activity that initially appears 8 – 20 h after exercise, peaks at 24 – 48 h after exercise and persists for several days and affect performance. The aim of the present study was to examine the physiological effects of selenium supplementation on delayed-onset muscle soreness and muscle damage. Thirty-two recreational male students of Sports Science Department, Universitas Negeri Surabaya were randomly and double-blindly assigned to either a selenium supplementation group (n=16) or a Placebo group (n=16) and were directed to take either a selenium capsule or a placebo for a period of 3-weeks. Following the 3-weeks supplementation period, both groups underwent a 10-set x 10-rep countermovement jump (1-min recovery between sets) as an eccentric exercise protocol. Pain of DOMS and CK level were measured prior to the eccentric exercise 1-hr before, 24-hr and 48-hr after eccentric exercise. the result of this study showed that both groups experienced Delayed Onset Muscle Soreness (DOMS) and increased total CK serum within 24 to 48 hours post heavy eccentric exercise. The results indicated that the selenium-supplemented group had a significantly greater reduction in plasma DOMS and total CK serum compared to the Placebo group (p&amp;lt;0.05). In summary, selenium supplementation might lower the risk of muscle injury after heavy eccentric exercise, as it effectively reduces plasma DOMS and CK levels in the bloodstream

Perioperative Supplemental Oxygen for the Prevention of Surgical Site Infection After Cesarean Section: A Systematic Review of Existing Literature.

Initial systematic reviews demonstrated the reduction of surgical site infection (SSI) following perioperative oxygen supplementation. SSI among colorectal surgeries was reduced by more than 50% with high-flow oxygen. However, recent randomized trials are coming up with conflicting results. The objective of this review was to comprehend whether the application of perioperative supplemental oxygen decreased the hazard of SSI following cesarean delivery.The initial search identified 95 studies. After screening title and abstracts 59 studies were included, and 33 studies were found to be relevant after checking eligibility. After a careful analysis, five articles were found fit for this systematic review. Extracted information included study design and methodology, the cumulative incidence of post-cesarean SSI following supplemental oxygen, the odds ratio, and associated variability for all factors considered in univariate and/or multivariate analysis. The cumulative incidence of the standard care group and supplemental oxygen group were comparable in all five studies with statistically significant differences. The secondary outcomes such as hospital readmission, wound separation, and intravenous antibiotics were similar in both groups as stated in the two studies. The rate of SSI in diabetics was 6.9% and 14.4% in the standard care group and supplemental oxygen group, respectively, as analyzed in a study. An increase in intra-operative blood loss was found to be the major risk factor leading to SSI. In one of the studies, Caucasian race, increased basal metabolic index, and prolonged surgery were associated with increased risk of SSI. There was no difference in neonatal umbilical artery pH resulting from supplemental oxygen during cesarean.The available literature is quite sufficient to prove that supplemental oxygen offers no added benefit in reducing post-cesarean SSI. Hence, we do not recommend its use for this purpose.

Associations of fish oil with cardiovascular disease events: results from the Taiwan longitudinal study in aging

BackgroundThe effectiveness of fish oil in preventing cardiovascular events is still debating. Some studies indicate a correlation between the use of fish oil supplements and reduced mortality or decreased incidence of stroke. However, other studies show no significant association between fish oil intake and stroke prevention, indicating an ongoing debate. This study aimed at exploring which subjects may benefit more from fish oil supplementation.MethodsThis study utilized the data obtained through face-to-face interview from the Taiwan Longitudinal Study in Aging (TLSA). A total of 3,652 participants were included from the 2003 baseline data, after excluding patients with pre-existing ischemic heart disease or stroke. Participants were divided into two groups based on whether taking fish oil supplement or not. Participants were followed until 2015, estimating and comparing the all-cause mortality and cumulative incidence rate of stroke between both groups.ResultsThe results of the 12-year longitudinal study showed that the cumulative incidence rate of stroke in the fish oil supplementation group was 5.7%, compared to 7.7% in the non-supplemented group (P < 0.05). Additionally, the crude hazard ratio for stroke was significantly lower in the fish oil supplementation group (HR = 0.686;95% CI 0.476–0.987). However, after adjusting potential confounders, the adjusted risk of stroke was lower only for the diabetic patients supplemented with fish oil (aHR = 0.123; 95% CI 0.016–0.930) compared to non-diabetic patients (aHR = 0.917; 95% CI 0.616–1.364).ConclusionThis study suggests that there is an association between fish oil supplementation and a lower cumulative incidence rate of subsequent stroke among diabetic patients.

Dietary Pediastrum boryanum microalgal extract improves growth, enhances immunity, and regulates immune-related genes in Nile tilapia

BackgroundIdentifying alternative sustainable feed sources with high nutritional values is crucial for the future of environmentally and socially responsible aquaculture. In this regard, microalgae have been proven to have positive effects on fish health, which overwhelmed our interest in this study.MethodsPediastrum boryanum (P. boryanum) was incorporated into Nile tilapia feed at concentrations of 0, 0.75, and 1.5 mg/kg, as control, PbExt0.75, and PbExt1.5 groups to assess its effects on growth and biochemical indices, oxidant/antioxidant activities, immune and stress-related gene expression, and intestinal morphology.ResultsAfter 8 weeks, fish fed P. boryanum supplemented feed exhibited significant increases in final weight, length, condition factor, body weight gain, and specific growth rate, while the spleen-somatic index (SSI) and hepatosomatic index (HSI) showed no significant differences compared to the control group. Dietary P. boryanum supplementation also enhanced IgM levels and lysozyme activity, along with no marked effect on markers of liver function enzymes (alanine aminotransferase/ALT and aspartate aminotransferase/AST) or protein status (total protein and albumin). Furthermore, P. boryanum addition increased the activity of superoxide dismutase (SOD), catalase (CAT), and reduced glutathione (GSH) enzymes, highlighting its antioxidant potential, whereas malondialdehyde (MDA) concentrations showed no significant differences among the groups. Gene expression analysis revealed that tumor necrosis factor-α (TNF-α), interleukin-10 (IL-10), and transforming growth factor-β1 (TGF-β1) expression notably increased in groups fed P. boryanum containing feed, while no significant difference was observed in hepatic Heat Shock Protein 70 (HSP70) mRNA expression. Histopathological examination revealed no adverse effects of P. boryanum supplementation on the liver, spleen, or intestinal tissues. Villous height and villous surface area were notably increased in the high P. boryanum supplementation group, suggesting improved intestinal integrity and nutrient absorption.ConclusionDietary P. boryanum supplementation can potentially improve growth performance, immune response, antioxidant status, and intestinal health of Nile tilapia, making it a promising candidate for sustainable aquaculture.

Efficacy of daily versus intermittent oral iron supplementation for prevention of anaemia among pregnant women: a systematic review and meta-analysis

The World Health Organization recommends daily oral supplementation of iron for prevention of maternal anaemia. However, the adverse effects due to daily supplementation leads to poor compliance among pregnant women. Also, the mucosal block theory suggests that intermittent oral iron may be more efficient than daily iron with respect to optimum absorption. Our meta-analysis reviewed the existing clinical studies for the efficacy of daily versus intermittent oral iron supplementation. In this systematic review and meta-analysis [PROSPERO ID:CRD42024498180], we searched PubMed, Google Scholar, Scopus, Science Direct and Cochrane database for studies published from 1st January 1970 to 31st December, 2023. Studies comparing daily and intermittent iron supplementation in pregnant women were included. The median intermittent iron dose was 120mg/day and daily iron dose was 60mg/day. The primary outcome was endpoint haemoglobin levels after iron supplementation. The data was analysed using the 'meta' and 'metafor' packages in RStudio using random effects model. The heterogeneity, publication bias, risk of bias and certainty of evidence were assessed using I2 statistics, funnel plots, Cochrane Risk of Bias 2 (ROB2) tool, and the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach respectively. Of 4615 search results, 26 studies (n=4365 participants) were included in this meta-analysis. There was no significant difference (p=0.18) between the endpoint mean haemoglobin levels of the daily versus intermittent oral iron groups (standardized mean difference (SMD): 0.51, 95% CI:-0.23 to 1.24, I2=97%, low certainty evidence) irrespective of baseline anaemic status. However, the endpoint ferritin levels were significantly higher in the daily supplementation group (SMD: 0.85, 95% CI: 0.15-1.54, p=0.02, I2=97%, low certainty evidence). The adjusted odds ratio for nausea, (adjusted odds ratio (OR) 3.56, 95% CI: 2.23-5.69, p<0.001, I2=9%, moderate certainty evidence), diarrhoea (adjusted OR 5.40, 95% CI: 1.90-15.33, p=0.002, I2=0%, low certainty evidence) and constipation (adjusted OR 1.95, 95% CI: 1.21-3.14, p=0.006, I2=0%, moderate certainty evidence) was significantly higher in daily oral iron supplementation group. Intermittent oral iron supplementation with a median dose of 120mg/day demonstrates comparable efficacy to daily oral iron supplementation median dose of 60mg/day in increasing haemoglobin levels among pregnant women with a significant reduction in adverse events. There was no funding for this study.

The role of vitamin D in amelioration of oral lichen planus and its effect on salivary and tissue IFN-γ level: a randomized clinical trial

Background and objectivesOral lichen planus (OLP) is a common, prevalent, immune-mediated, inflammatory disease affecting both the skin and oral mucosa and is considered one of the potentially malignant diseases. Since OLP is regarded as an immunologically mediated disease, some studies suggest the use of vitamin D (VD) for its management as it exhibits immune-modulatory, anti-inflammatory, and antimicrobial properties, as well as anti-proliferative, pro-differentiative, and anti-angiogenic effects. VD has demonstrated a suppressive effect on TH1 pro-inflammatory cytokines, including IFN-γ while augmenting the secretion of anti-inflammatory cytokines. At the same time, VD deficiency is a prevalent public issue. Therefore, the present study aimed to investigate the role of VD as an adjunct to steroids in the management of VD-deficient OLP patients as well as its inhibitory effect on IFN-γ through measurement of salivary and tissue IFN-γ levels in OLP patients.MethodsA total of 40 patients with ulcerative or erythematous OLP, diagnosed according to the World Health Organization’s (WHO) modified criteria for OLP, were randomly allocated into one of the two study groups to receive either systemic steroids in addition to VD supplements (Group A) or systemic steroids only (Group B). Blood samples were collected for the measurement of serum VD level (SVDL) using the enzyme-linked immunosorbent assay (ELISA) to involve only patients with VD deficiency or insufficiency (≤ 30 ng/ml). Clinical evaluation of the lesion involved objective signs and subjective symptoms. Also, changes in salivary and tissue INF-γ levels (in pg/mL and pg/mg, respectively) were determined using the ELISA technique. All parameters were measured at baseline and after 4 weeks of treatment. The clinical pharmacy team devised a checklist to record all team interventions. The interventions were categorized into six domains, including drug interactions and/or adverse reactions, medication dose issues, drug selection issues, support with medication history, patient-related concerns, and suggestions for dental medication.ResultsAfter one month of treatment, a significantly greater number of patients in group A showed complete pain relief and resolution of clinical lesions, as well as a greater number of patients showing a reduction in the clinical severity of lesions than in group B (P = 0.005). Also, there was a statistically significant reduction in average VAS pain scores and clinical scores in group A compared to group B after 1 month of treatment (P = 0.001 and 0.002, respectively). Furthermore, there was a statistically significant greater reduction in salivary and tissue IFN-γ levels in group A than in group B (P ≤ 0.001 and 0.029, respectively) after 1 month of treatment.ConclusionCurrent evidence suggests a significant preventive and therapeutic role for VD as an adjunct to standard therapies indicated for OLP lesions. These protective and therapeutic functions are achieved through the suppressive effect of VD on pro-inflammatory cytokines, particularly IFN-γ. Also, salivary IFN-γ appears to be a valuable prognostic marker for monitoring the progression of OLP. In addition, the inter-professional collaboration between dentists and clinical pharmacists helped to deliver complete, patient-centered primary care and ensured the quality of the medications included in patient kits, thus improving patient treatment and management. Nevertheless, further studies with larger sample sizes, longer follow-ups, and standardized designs may still be needed.

Effectiveness of food supplement on treatment outcomes and quality of life in pulmonary tuberculosis: Phased implementation approach.

By encouraging treatment adherence and lowering mortality, dietary supplements can serve as adjuvant therapy for the success of medical interventions. We determined the effect of locally accessible food supplements on treatment outcomes, and health-related quality of life in patients with pulmonary tuberculosis initiating anti-tuberculosis treatment (ATT) in Odisha, India. Between September 2017 and December 2018, implementation research in patients with newly diagnosed sputum smear-positive pulmonary tuberculosis initiating ATT in five districts of the tribal belt of Odisha, offered food supplements along with ATT in a phased manner. Clinical symptoms, anthropometry, sputum for M. tuberculosis (M. tb), health-related quality of life and return to normal function were assessed periodically, and favourable treatment outcome (cure or treatment completed) was measured at the end of treatment. The effect of the food supplement on unfavorable outcomes (treatment failure, death, or lost-to-follow-up) was modelled using mixed-effects Poisson regression to determine the risk factors. Among the 761 participants enrolled, 614 participants received the food supplement and 147 did not receive the food supplement. Among the 614 participants in the supplement group, 537 (87%) had a favorable outcome and among the 147 participants in the no-supplement group, 113 (77%) had a favorable outcome (p = 0.0017). Higher age (>55 years) [aRR = 2.1(95% CI: 1.1-3.8)], male gender [aRR = 1.7(95% CI: 1.2-2.9)], and smear grading ≥2+ [aRR = 1.5 (95% CI: 1.1-2.2)] were associated with unfavorable treatment outcomes. Nutritional status, quality of life and lung health showed significant improvement from baseline in the supplement group. Improvement in the nutritional status of the patient can be considered a predictor of treatment success rates. Early food supplementation has a positive impact on the nutritional status.

A Randomized Controlled Trial of the Safety and Efficacy of Systemic Enzyme Supplementation on Symptoms and Quality of Life in Patients with Idiopathic Pulmonary Fibrosis.

Idiopathic pulmonary fibrosis (IPF) imposes a substantial symptom burden that adversely impacts patients' quality of life. Current anti-fibrotic treatments for IPF provide limited symptomatic relief, necessitating the implementation of complementary disease management strategies to enhance health-related quality of life (HRQOL). Serracor-NK® and Serra Rx260, systemic enzyme supplements, improved symptoms and HRQOL with favorable safety profiles in a proof-of-concept study in PF patients. This prospective, double-blind randomized placebo-controlled trial enrolled 100 IPF patients from six institutions. The supplement group (n = 50) received the oral systemic enzyme supplements Serracor-NK® and Serra Rx260 in addition to standard care for 6 months, while the placebo group (n = 50) received standard care alone. The primary objective was to evaluate the regimen's impact on symptoms, QOL, and well-being using the UCSD shortness of breath (UCSD-SOB) questionnaire, St. George's respiratory questionnaire (SGRQ), and WHO well-being index (WHO-5). Safety evaluation was a secondary objective. A significantly higher proportion of patients in the supplement group demonstrated meaningful improvement in symptoms as compared to the placebo group, as assessed by the UCSD-SOB (p < 0.05) and SGRQ questionnaires (p < 0.05). Additionally, a significantly greater proportion of patients in the supplement group showed improved QOL and well-being (p < 0.05) and reduced health impairment (p < 0.05), as assessed by SGRQ. Mental well-being (WHO-5) and physical activity (SGRQ activity domain) did not differ significantly between the groups. Safety assessments, including liver function tests and vital signs, indicated that the supplement regimen was well tolerated. To conclude, Serracor-NK® and Serra Rx260 alleviate symptoms and enhance HRQOL in IPF patients with a favorable safety profile (Clinical Trials Registry India registration number: CTRI/2020/05/025374).

New Strategy for Browning Prevention in Apple Pomace Processing and Toxicity Tested in a Rodent Model.

Apple pomace (AP) is a byproduct of apple juice industries, which constitutes around 30% of the original fruit and rich in essential compounds like carbohydrates, phenolics, minerals, and dietary fibers. This study is focused on optimizing the combinational utilization of antibrowning agents like l-cysteine and l-ascorbic acid for the sustainable debrowning of AP with response surface methodology and assessment of its acute toxicity in female rats. In addition, the phytochemical content and antioxidant activity of treated AP were investigated and compared with the untreated control AP. The study revealed that the treated AP has higher dietary fiber (p < 0.01), protein (p < 0.0001), and phenolic content (p < 0.001) in comparison to the control AP. Moreover, the treated AP also observed with higher antioxidant activity 37% inhibition and water retention capacity (8.5 g H2O/g solid) along with the debrowning effect. Furthermore, a 4-week in vivo study is conducted to assess the toxicity of treated AP. Results indicated no discernible variations in biochemistry, morphometric, or histology between the supplementation (0.5, 1.5, and 3% AP) and control groups. Thus, adding AP rich in dietary fiber to a range of meals is deemed a safe and valuable food supplement.

Effects of dietary Chitosan oligosaccharides supplementation on Th17/Treg balance and gut microbiota of early weaned pigeon squabs

Our previous study found that early weaning is associated with decreased growth performance, intestinal barrier impairment, and an imbalance in Th17/Treg in pigeon squabs. Chitosan oligosaccharides (COS) has been substantiated to regulate gut microbiota and restore Th17/Treg equilibrium in mammals, thereby ameliorating growth performance. However, the potential effects of COS in altricial birds remain unclear. Three hundred healthy 7-day-old American king pigeon squabs were selected with similar body weights and randomly divided into 5 groups. The 5 treatment groups were as follows: the control group (CON), fed with artificial pigeon milk; 4 supplementation groups, fed with artificial pigeon milk +100 (COS1), 150 (COS2), 200 (COS3), and 250 (COS4) mg/kg COS, respectively. Results showed that dietary supplementation of COS significantly enhanced the growth performance of weaned squabs. Compared to the CON group, the COS groups exhibited increased villus length and villus area in the jejunum and ileum, accompanied by improvements in morphological structure and mucosal permeability. COS was found to reduce the levels of Th17-associated cytokines and increase the levels of Treg-associated cytokines. COS downregulated the expression of retinoic acid receptor-related orphan receptor C (RORC), a key transcription factor of Th17 cells, while upregulated the expression of Forkhead box protein P3 (FOXP3), a key transcription factor of Treg cells. Dietary COS supplementation increased gut bacterial diversity, altered the relative abundance of several bacteria taxa and enhanced the concentration of short-chain fatty acids (SCFA). Correlation analysis demonstrated a close association between gut microbiota, SCFAs, and indicators related to the Th17/Treg balance. Moreover, we found that SCFAs correlated more strongly with Th17/Treg-related indexes than gut microbiota. These results demonstrated that COS could relieve early weaning stress in pigeon squabs and the optimal dosage of dietary COS supplementation was suggested to be 200 mg/kg. In addition, COS had a protective effect on maintaining intestinal immune balance by modulating microbiota and Th17/Treg related signaling pathways, in which SCFAs might play a crucial role as messengers.

Prevalence of vitamin D deficiency and the effect of vitamin D3 supplementation on response to anti-tuberculosis therapy in patients with extrapulmonary tuberculosis

BackgroundWe aimed to assess serum 25-hydroxyvitamin D3 (25(OH)D3) concentrations in extrapulmonary tuberculosis (EPTB) patients and to evaluate the effect of vitamin D3 supplementation on their treatment course.MethodsSerum 25(OH)D3concentrations were measured in 47 newly diagnosed EPTB patients and 42 controls. Vitamin D-deficient EPTB patients were randomly assigned to receive 50,000 IU of vitamin D3 (cholecalciferol) orally once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1000 IU a day besides anti-TB drugs or the first line anti-TB treatment only. Follow up serum 25(OH)D3 concentrations were measured after 3 months of starting vitamin D3 supplementation. Both groups were evaluated for clinical, laboratory, and radiological outcomes after treatment.ResultsSerum 25(OH)D3 concentrations were significantly lower among TB cases (17.1 ± 5.5 nmol/L) compared to healthy controls (51.8 ± 27.3 nmol/L), and vitamin D deficiency was observed in all EPTB patients (n = 47). Patients in VD3 supplementation group had significantly higher weight gain and serum albumin level at 2 months and end of treatment, higher hemoglobin concentration at the end of treatment, significantly lower CRP and ESR at 2 months and at the end of treatment. In cases with TB pleurisy, a significant higher rate of full resolution of pleural fluid after 6 months of anti-TB treatment and shorter treatment duration were noted compared to the other group.ConclusionsVitamin D deficiency is prevalent in EPTB patients, in whom, vitamin D supplementation is a useful adjunctive therapy to anti-TB drugs and improves treatment course.

O-147 Role of serum progesterone levels and subcutaneous progesterone supplementation in endometriosis patients undergoing artificial cycle frozen embryo transfer

Abstract Study question Is there any impact of serum progesterone levels and subcutaneous progesterone supplementation on live birth rate in endometriosis patients undergoing Artificial Cycle-Frozen Embryo Transfer (AC-FET)? Summary answer Endometriosis patients have comparable progesterone levels before transfer to those without endometriosis. Progesterone supplementation results in similar live birth rate (LBR) to the general population. What is known already Progesterone (P4) resistance is a hallmark of uterine alterations in endometriosis. This disease could disrupt balance between progesterone and estrogen signaling pathways, resulting in estrogen dominance and progesterone resistance at the receptor level, which warrants a deeper exploration for adjusting dosages when performing AC-FET. A recent retrospective study highlights the potential significance of a progesterone threshold when using vaginal and intramuscular progesterone systematically in AC-FET, correlating with a significantly higher LBR for endometriosis-patients. However, no current studies have compared LBR according to P4 the day before blastocyst-transfer and progesterone supplementation in endometriosis versus non-endometriosis-patients undergoing AC-FET with standard vaginal treatment. Study design, size, duration This is a retrospective cohort study including 985 cycles undergoing autologous AC-FET with standard vaginal progesterone treatment (600 mg/day) at a university-affiliated fertility center from January 2019 to December 2022. 168 cycles were from patients with confirmed endometriosis. LBR was evaluated in both groups based on P4 levels the day before transfer. Progesterone supplementation via SC injection (25 mg/day) was administered when levels were deemed low (&amp;lt;10.6 ng/mL based on our previously published research). Participants/materials, setting, methods Endometrial preparation involved oral estrogens at 6 mg daily from the begging of menstrual cycle. Micronized vaginal progesterone (600 mg/day) was added when thickness reached 7 mm. P4 was measured before embryo transfer; supplementation (25 mg SC injection) was added if &amp;lt; 10.6 ng/mL. FET occurred 6 days after initiating luteal phase support. Treatment continued until the pregnancy test. If pregnant, treatment ceased at 10 weeks of amenorrhea. Main results and the role of chance Comparisons between endometriosis and non-endometriosis groups revealed similar baseline characteristics regarding age, BMI, parity, number of embryos transferred, and embryo quality. The number of cycles with levels ≥10.6 ng/mL before transfer were comparable between patients with and without endometriosis (aOR 0.98, 95% CI 0.65-1.47) according to a multivariable logistic regression analysis adjusting for age, BMI, and prior progesterone levels &amp;lt;10.6ng/mL the day before transfer. Unadjusted findings demonstrated equivalent clinical pregnancy, miscarriage, and live birth rates in endometriosis compared to non-endometriosis patients. A subsequent multivariable logistic regression analysis to analyze LBR was conducted, considering four groups: Group 1: Endometriosis with progesterone &amp;lt;10.6ng/mL and SC supplementation (51 patients) Group 2: Endometriosis with progesterone ≥10.6ng/mL (117 patients) Group 3: Non-endometriosis with progesterone &amp;lt;10.6ng/mL and SC supplementation (274 patients) Group 4: Non-endometriosis with progesterone ≥10.6ng/mL (543 patients) Adjusted for age, BMI, and embryo quality, Group 1 was considered as the reference. Results showed comparable live birth rates between the reference group and Group 2 (aOR 0.79, 95% CI 0.36-1.74), Group 3 (aOR 0.91, 95% CI 0.45-1.8), and Group 4 (aOR 1.9, 95% CI 0.71-2.74). Subcutaneous supplementation for endometriosis patients with P4&amp;lt;10.6ng/mL the day before embryo transfer led to similar LBR compared to the other groups. Limitations, reasons for caution The main limitation of this study is the single-center retrospective approach. While the total number of endometriosis patients is 168, the representation of endometriosis patients in group 1 may be a study limitation. Furthermore, all endometriosis stages were analyzed together although this may be clinically distinct entities. Wider implications of the findings Endometriosis patients have the same risk to have P4&amp;lt;10.6ng/mL the day before FET as non-endometriosis patients. Vaginal progesterone, with subcutaneous supplementation if necessary, appears user-friendly, leading to a comparable live birth rate to that of patients with normal progesterone levels before transfer, regardless of endometriosis status. Trial registration number not applicable