Double-blind Randomized Crossover Study Research Articles

Beta-glucan intake with energy and carbohydrate restricted meals: impact on subjective appetite and gastrointestinal appetite hormones in overweight adults

Energy restriction is commonly used as body weight-loss interventions (1). However, it modifies secretion of gastrointestinal appetite hormones, which might be expected to upregulate appetite and thus impair the ability to comply with prescribed intervention(1). Supplementation with soluble fibre may potentially counteract this matter (2). This study aimed to investigate whether addition of β- glucan to energy and carbohydrate-restricted meals impacts postprandial responses of gastrointestinal appetite hormones and subjective appetite in overweight adults.Twenty-three sedentary individuals living with overweight or obesity (age: 36 ± 8.5 years, BMI: 31.12 ± 4.04 kg/m2) participated in a double-blind randomised crossover study with two experimental arms, each lasting over two days. On day 1, participants consumed Counterweight PRO800 meal replacement shakes/soups for breakfast and dinner at home, each providing ~200 kcal and a carbohydrate-restricted lunch providing 35% of their habitual energy intake. On day 2, participants attended the metabolic investigation room where they consumed the same breakfast and lunch as on day 1. On both days, each meal was taken with either 3g β-glucan (Oat Well) or cellulose (Comprecel) as placebo. On Day 2, fasting and postprandial appetite scores were recorded, and fasting and postprandial blood samples were obtained for the measurements of plasma concentration of acylated ghrelin, PYY, and GLP-1. The study is registered at www.clinicaltrials.gov as NCT05981404.Two-way ANOVA showed that the postprandial concentrations of acylated ghrelin (β-glucan arm, 383 ± 23 pg/ml; placebo arm, 428 ± 23 pg/ml, P=0.02, treatment effect) and composite appetite scores (P=0.003, treatment effect) were significantly lower and PYY concentrations (β-glucan arm, 132 ± 5 pg/ml; Placebo arm, 110 ± 4 pg/ml, P= 0.003, treatment effect) significantly higher in the β- glucan arm than in the Placebo arm. The concentrations of GLP-1 were not different between arms (β-glucan arm, 29 ± 1 pM; placebo arm, 28 ± 0.9 pM, P=0.36, treatment effect).The obtained data suggests that consuming β -glucan with energy and carbohydrate-restricted meals can be expected to attenuate reduction in satiety and diminish increase in hunger. Therefore, supplementation with β-glucan during energy restriction intervention applied to body weight loss might lead to improve compliance and reduce discomfort of negative energy balance.

A multicenter double-blind randomized crossover study comparing the impact of dorsal subthalamic nucleus deep brain stimulation versus standard care on apathy in Parkinson’s disease: a study protocol

BackgroundNeuroimaging studies suggest an association between apathy after deep brain stimulation (DBS) and stimulation of the ventral part of the subthalamic nucleus (STN) due to the associative fibers connected to the non-motor limbic circuits that are involved in emotion regulation and motivation. We have previously described three patients with severe apathy that could be fully treated after switching stimulation from a ventral electrode contact point to a more dorsal contact point.ObjectivesTo determine whether more dorsal stimulation of the STN decreases apathy compared to standard care in a multicenter randomized controlled trial with a crossover design.MethodsWe will include 26 patients with a Starkstein Apathy Scale (SAS) score of 14 or more after subthalamic nucleus (STN) deep brain stimulation (DBS) for refractory Parkinson’s disease. This is a multicenter trial conducted in two teaching hospitals and one university medical center in the Netherlands after at least 3 months of STN DBS. Our intervention will consist of 1 month of unilateral dorsal STN stimulation compared to treatment as usual. The primary outcome is a change in SAS score following 1 month of DBS on the original contact compared to the SAS score following 1 month of DBS on the more dorsal contact. Secondary outcomes are symptom changes on the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale motor part III, Montgomery-Åsberg Depression Rating Scale, 39-item Parkinson’s disease questionnaire, Parkinson’s disease impulsive-compulsive disorders questionnaire, changes in levodopa-equivalent daily dosage, apathy rated by the caregiver, and burden and quality of life of the caregiver.Trial registrationClinicalTrials.gov NL8279. Registered on January 10, 2020.

Effects of peppermint oil inhalation on vertical jump performance in elite young professional soccer players: A double-blinded randomized crossover study

AimsTo evaluate peppermint essential oil (PEO) inhalation's effect on young soccer athletes' motor performance. MethodsA randomized crossover design was used to test the effect of the PEO. Eleven U-17 soccer players were evaluated into two conditions (PEO and Placebo – PLA). The players were tested in squat jump and countermovement jump and inhaled PEO or PLA and 10 min later performed the physical tests again. A mixed ANOVA was performed to test the hypotheses. ResultsMain effects were found for the time in jumping height in the CMJ (p = 0.037). No main and interaction effects were found in the SJ variables. ConclusionFrom the results, decrease CMJ performance acutely, both conditions presented decrease in JH, but based in effect size, PLA decrease is higher (more sample size for corroborate this) possibly due to improvements in the eccentric yielding sub-phase, where mentioned phase could be reflecting neural changes (required experimental verification). The PEO could be the interest in trainers for use before of match or in the half-time for minimize the decreased of physical performance by the rest.

Hemodynamic Effects of Intermittent Pneumatic Compression on Athletes: A Double-Blinded Randomized Crossover Study.

There are multiple postexercise recovery technologies available in the market based on the assumption of blood-flow enhancement. Lower-limb intermittent pneumatic compression (IPC) has been widely used, but the available scientific evidence supporting its effectiveness remains scarce, requiring a deeper investigation into its underlying mechanisms. The aim of this study was to assess the hemodynamic effects caused by the use of IPC at rest. Twenty-two soccer and track and field athletes underwent two 15-minute IPC protocols (moderate- [80mm Hg] and high-pressure [200mm Hg]) in a randomized order. Systolic peak velocity, end-diastolic peak velocity, arterial diameter, and heart rate were measured before, during (at the eighth minute), and 2minutes after each IPC protocol. Significant effects were observed between before and during (eighth minute) the IPC protocol for measures of systolic (P < .001) and end-diastolic peak velocities (P < .001), with the greater effects observed during the high-pressure protocol. Moreover, 2minutes after each IPC protocol, hemodynamic variables returned to values close to baseline. Arterial diameter presented significant differences between pressures during the IPC protocols (P < .05), while heart rate remained unaltered. IPC effectively enhances transitory blood flow of athletes, particularly when applying high-pressure protocols.

Ultrasound evaluation of gastric emptying time of standardized high-calorie liquid meals in healthy adults: A double-blind cross-over randomized study

Commercially available high-calorie drinks containing fat and protein can be used as dietary supplements in surgical patients. According to preoperative fasting guidelines, high-calorie drinks are non-clear fluids and should not be consumed 6h before elective procedures. The aim of this study was to evaluate the gastric emptying time of commercially available high-calorie drink formulations in healthy adults using gastric ultrasound. 25 healthy adult volunteers were included in this double-blind, cross-over prospective study. On three study sessions, fasted volunteers ingested one of the three study products: a solution of 75g of glucose in 200ml of water, a fat-free liquid meal, and a nutritionally complete liquid meal with equal volume and energy content. Gastric ultrasound examinations were performed to evaluate the gastric contents qualitatively and the volume of the gastric contents was calculated from the cross-sectional area of the gastric antrum measured in right lateral position by using a validated model. Repeated gastric ultrasounds were performed at baseline and half-hourly after ingesting the products in supine and right lateral position until the criteria for an empty stomach were met. The glucose solution and the standard fat-free high-calorie drink with the same caloric content had a median gastric emptying time of 150min. The nutritionally complete liquid meal had a median gastric emptying time of 180min. Gastric emptying was complete in all participants before 6h had elapsed since ingesting the study products. High calorie liquid meals have a gastric emptying time longer than the recommended fasting time for clear fluids, but shorter than the recommended fasting time for solids in healthy adults.

Fourteen-Days Spirulina Supplementation Increases Hemoglobin, but Does Not Provide Ergogenic Benefit in Recreationally Active Cyclists: A Double-Blinded Randomized Crossover Trial

Spirulina supplementation has been reported to increase hemoglobin concentration as well as a variety of cardiorespiratory and lactate-based performance parameters during maximal and submaximal states of exercise. This study investigates the efficacy of supplementing a 6 g/day dosage of spirulina for 14-days in recreationally active individuals, analyzing cardiorespiratory parameters during maximal and submaximal cycling as well as the potential mechanistic role of hemoglobin augmentation. 17 recreationally active individuals (Male = 14, Female = 3, Age 23 ± 5 years, V̇O2max 43.3 ± 8.6 ml/min·kg) ingested 6 g/day of spirulina or placebo for 14-days in a double-blinded randomized crossover study, with a 14-day washout period between trials. Participants completed a 20-min submaximal cycle at 40% maximal power output (WRmax), followed by a V̇O2max test. Hemoglobin (g/L), WRmax (watts), time to fatigue (seconds), heart rate (bpm), oxygen uptake (ml/min·kg), RER and blood lactate response (mmol/L) were measured and compared between conditions. Cardiorespiratory variables were recorded at 5-min intervals and lactate was measured at 10-min intervals during the submaximal exercise. There was a significant 3.4% increase in hemoglobin concentration after spirulina supplementation in comparison to placebo (150.4 ± 9.5 g/L Vs 145.6 ± 9.4 g/L, p = 0.047). No significant differences existed between either condition in both testing protocols for V̇O2max, WRmax, time to fatigue, heart rate, oxygen uptake, RER and blood lactate response (p > 0.05). 14-days of spirulina supplementation significantly improved hemoglobin concentration but did not lead to any considerable ergogenic improvements during maximal or submaximal exercise at a 6 g/day dosage in recreationally active individuals whilst cycling.

Enhanced secretion of satiety-promoting gut hormones in healthy humans after consumption of white bread enriched with cellular chickpea flour: A randomized crossover study

BackgroundDietary intake of pulses is associated with beneficial effects on body weight management and cardiometabolic health, but some of these effects are now known to depend on integrity of plant cells, which are usually disrupted by flour milling. Novel cellular flours preserve the intrinsic dietary fiber structure of whole pulses and provide a way to enrich preprocessed foods with encapsulated macronutrients. ObjectivesThis study aimed to determine the effects of replacing wheat flour with cellular chickpea flour on postprandial gut hormones, glucose, insulin, and satiety responses to white bread. MethodsWe conducted a double-blind randomized crossover study in which postprandial blood samples and scores were collected from healthy human participants (n = 20) after they consumed bread enriched with 0%, 30%, or 60% (wt/wt) cellular chickpea powder (CCP, 50 g total starch per serving). ResultsBread type significantly affected postprandial glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) responses (time × treatment, P = 0.001 for both). The 60% CCP breads elicited significantly elevated and sustained release of these anorexigenic hormones [between 0% and 60% CPP—GLP-1: mean difference incremental area under the curve (iAUC), 3101 pM/min; 95% CI: 1891, 4310; P-adjusted < 0.001; PYY: mean difference iAUC, 3576 pM/min; 95% CI: 1024, 6128; P-adjusted = 0.006] and tended to increase fullness (time × treatment, P = 0.053). Moreover, bread type significantly influenced glycemia and insulinemia (time × treatment, P < 0.001, P = 0.006, and P = 0.001 for glucose, insulin, and C-peptide, respectively), with 30% CCP breads eliciting a >40% lower glucose iAUC (P-adjusted < 0.001) than the 0% CCP bread. Our in vitro studies revealed slow digestion of intact chickpea cells and provide a mechanistic explanation for the physiologic effects. ConclusionsThe novel use of intact chickpea cells to replace refined flours in a white bread stimulates an anorexigenic gut hormone response and has potential to improve dietary strategies for prevention and treatment of cardiometabolic diseases.This study was registered at clinicaltrials.gov as NCT03994276.

Effect of Narcotic Analgesia on Decision to Operate in Acute Appendicitis

Aim: To study that narcotic analgesia administration in patients of acute appendicitis does not delay the diagnosis and does not interfere with the decision to operate in these patients. Study design: A randomized cross-over study. Setting and duration of study: Study was done at surgery department of Combined military hospital Lahore over a period of two years from March 2019-2021. Methodology: It was a double-blind randomized crossover study. A total of 100 patients, who were confirmed as acute appendicitis by clinical examination, were included. All the male and female patients of age 16 years and above were included in the study. The patients were divided in two groups each having 50 patients. The drugs were labelled as drug A and drug B. Drug A was morphine and drug B was placebo. Each drug was given to both the groups by crossover with an interval of 30 minutes and the components of physical examination were analyzed for both groups. The pain score was calculated by the visual analogue scale (VAS) for both the groups at both intervals. The p-value was calculated by using student’s t-test. The frequency and percentages of the decision to operate were calculated. The data was tabulated and then analyzed on SPSS version 23. Results: The pain score was calculated for both groups of male and females. The pain score difference was calculated in both groups and then p-value was calculated which came out to be significant. The frequencies of the decision to be operated were also calculated in both the groups and the results showed that there was no effect of narcotic analgesia on the decision to operate in patients with clinically diagnosed acute appendicitis Conclusion: The use of morphine analgesia in the patients of acute appendicitis does not alter the diagnostic efficacy of the patients of acute appendicitis. Keywords: Acute abdominal pain, acute appendicitis, Narcotic analgesia, Visual analog scale (VAS)

The phase of sensorimotor mu and beta oscillations has the opposite effect on corticospinal excitability

BackgroundNeural oscillations in the primary motor cortex (M1) shape corticospinal excitability. Power and phase of ongoing mu (8–13 Hz) and beta (14–30 Hz) activity may mediate motor cortical output. However, the functional dynamics of both mu and beta phase and power relationships and their interaction, are largely unknown. ObjectiveHere, we employ recently developed real-time targeting of the mu and beta rhythm, to apply phase-specific brain stimulation and probe motor corticospinal excitability non-invasively. For this, we used instantaneous read-out and analysis of ongoing oscillations, targeting four different phases (0°, 90°, 180°, and 270°) of mu and beta rhythms with suprathreshold single-pulse transcranial magnetic stimulation (TMS) to M1. Ensuing motor evoked potentials (MEPs) in the right first dorsal interossei muscle were recorded. Twenty healthy adults took part in this double-blind randomized crossover study. ResultsMixed model regression analyses showed significant phase-dependent modulation of corticospinal output by both mu and beta rhythm. Strikingly, these modulations exhibit a double dissociation. MEPs are larger at the mu trough and rising phase and smaller at the peak and falling phase. For the beta rhythm we found the opposite behavior. Also, mu power, but not beta power, was positively correlated with corticospinal output. Power and phase effects did not interact for either rhythm, suggesting independence between these aspects of oscillations. ConclusionOur results provide insights into real-time motor cortical oscillation dynamics, which offers the opportunity to improve the effectiveness of TMS by specifically targeting different frequency bands.

Iron Bioavailability from Ferrous Ammonium Phosphate, Ferrous Sulfate, and Ferric Pyrophosphate in an Instant Milk Drink-A Stable Isotope Study in Children.

Ferrous ammonium phosphate (FAP) is an iron salt that has been developed for the fortification of food matrices sensitive to color and flavor changes. The objective of the study was to measure iron absorption from FAP in young children and compare it to a previous evaluation of FAP in young women. A double-blind randomized crossover study with two parallel arms was used to evaluate the iron absorption from FAP added to reconstituted milk powder in comparison to that from ferrous sulfate (FeSO4) and ferric pyrophosphate (FePP). Iron absorption was measured in 39 children aged 3- to 6-years-old using erythrocyte incorporation of stable Fe isotopes (57Fe, 58Fe). The geometric mean iron absorption in iron replete children from FAP, FeSO4 and FePP from milk was 8.3%, 7.6% and 2.1%, respectively. Iron absorption from FAP and FeSO4 fortified milk was not significantly different (p = 0.199); however, it was significantly higher than from FePP fortified milk (p < 0.001). Iron bioavailability from FAP and FePP relative to FeSO4 (relative bioavailability (RBV)) was 110% and 33%, respectively. The RBV of FAP (110%) in iron replete children was higher than previously reported RBV (71%) in mainly iron deficient women. The difference in iron status between the children and women in the respective studies may explain the different RBV values and is discussed.

Effect of caffeine on muscle oxygen saturation during short-term all-out exercise: a double-blind randomized crossover study

PurposeThe ergogenic effect of oral caffeine administration on short-term all-out exercise performance is well established. However, the potential mechanisms associated with caffeine’s ergogenicity in this type of exercise are poorly understood. The aim of this study was to investigate whether caffeine intake modifies muscle oxygen saturation during the 15-s Wingate Anaerobic Test.MethodsFifteen moderately trained individuals (body mass = 67.4 ± 12.3 kg; height 171.3 ± 6.9 cm; age 31 ± 6 years) took part in two identical experimental trials after the ingestion of (a) 3 mg/kg of caffeine or (b) 3 mg/kg of cellulose (placebo). After 60 min for substances absorption, participants performed a 15-s Wingate test on a cycle ergometer against a load representing 7.5% of participant’s body mass. Muscle oxygen saturation was continuously measured during exercise with near-infrared spectroscopy and blood lactate concentration was measured 1 min after exercise.ResultsIn comparison to the placebo, the oral administration of caffeine increased peak power by 2.9 ± 4.5% (from 9.65 ± 1.38 to. 9.92 ± 1.40 W/kg, P = 0.038; effect size (ES), 95% confidence intervals = 0.28, 0.05–0.51), mean power by 3.5 ± 6.2% (from 8.30 ± 1.08 to 8.57 ± 1.12 W/kg, P = 0.044; ES = 0.36, 0.01–0.71) and blood lactate concentration by 20.9 ± 24.7% (from 12.4 ± 2.6 to 14.8 ± 4.0 mmol/L, P = 0.005; ES = 0.59, 0.16–1.02). However, caffeine did not modify the curve of muscle oxygen desaturation during exercise (lowest value was 23.1 ± 14.1 and 23.4 ± 14.1%, P = 0.940).ConclusionCaffeine’s ergogenic effect during short-term all-out exercise seems to be associated with an increased glycolytic metabolism with no influence of enhanced muscle oxygen saturation.

A double-blind randomised placebo-controlled trial investigating the effects of lesogaberan on the objective cough frequency and capsaicin-evoked coughs in patients with refractory chronic cough.

ObjectiveBaclofen is a centrally acting γ-aminobutyric acid type B (GABAB) receptor agonist which reduces gastro-oesophageal reflux and suppresses the cough reflex; however, central nervous system side-effects limit its use. Lesogaberan is a novel peripherally acting GABAB agonist, but its effects on refractory chronic cough are unknown.DesignWe performed a single-centre, placebo-controlled, double-blind randomised crossover study in patients with chronic cough, refractory to the treatment of underlying conditions. Patients were randomised to treatment with lesogaberan 120 mg modified release twice daily or matched placebo for 2 weeks and then crossed over to the alternative therapy after a 2-week washout. The primary end-point was 24-h cough frequency measured with an acoustic monitoring system. In addition, cough responses to capsaicin were measured, and gastro-oesophageal reflux assessed by 24-h pH/impedance at screening.Results22 patients were randomised to receive lesogaberan/placebo or placebo/lesogaberan (female (73%); mean±sd age 63.7±7.2 years; median (interquartile range) cough duration 10.5 (5.8–17.0) years; mean (95% CI) 45 (29–67) reflux events in 24 h; two patients had abnormal oesophageal acid exposure times). Although lesogaberan reduced cough counts by 26% over placebo, this did not reach statistical significance (p=0.12). However, lesogaberan did significantly improve cough responses to capsaicin (p=0.04) and the number of cough bouts (p=0.04) compared with placebo. Lesogaberan was well tolerated in this study.ConclusionsLesogaberan improved cough hypersensitivity and the number of bouts of coughing, but not coughs per hour. This implies a possible role for peripheral GABAB receptors in refractory chronic cough.

Low-frequency STN-DBS provides acute gait improvements in Parkinson\u2019s disease: a double-blinded randomised cross-over feasibility trial

BackgroundSome people with Parkinson’s disease (PD) report poorer dynamic postural stability following high-frequency deep brain stimulation of the subthalamic nucleus (STN-DBS), which may contribute to an increased falls risk. However, some studies have shown low-frequency (60 Hz) STN-DBS improves clinical measures of postural stability, potentially providing support for this treatment. This double-blind randomised crossover study aimed to investigate the effects of low-frequency STN-DBS compared to high-frequency stimulation on objective measures of gait rhythmicity in people with PD.MethodsDuring high- and low-frequency STN-DBS and while off-medication, participants completed assessments of symptom severity and walking (e.g., Timed Up-and-Go). During comfortable walking, the harmonic ratio, an objective measures of gait rhythmicity, was derived from head- and trunk-mounted accelerometers to provide insight in dynamic postural stability. Lower harmonic ratios represent less rhythmic walking and have discriminated people with PD who experience falls. Linear mixed model analyses were performed on fourteen participants.ResultsLow-frequency STN-DBS significantly improved medial–lateral and vertical trunk rhythmicity compared to high-frequency. Improvements were independent of electrode location and total electrical energy delivered. No differences were noted between stimulation conditions for temporal gait measures, clinical mobility measures, motor symptom severity or the presence of gait retropulsion.ConclusionsThis study provides evidence for the acute benefits of low-frequency stimulation for gait outcomes in STN-DBS PD patients, independent of electrode location. However, the perceived benefits of this therapy may be diminished for people who experienced significant tremor pre-operatively, as lower frequencies may cause these symptoms to re-emerge.Trial registration: This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry on 5 June 2018 (ACTRN12618000944235).

802-P: Dapagliflozin Improves Glycolytic Reserve in Peripheral Blood Mononuclear Cells in Patients with Type 1 Diabetes

Sodium-glucose cotransporter-2 (SGLT2) inhibition is emerging as a beneficial adjunctive therapy in type 1 diabetes (T1D). It is hypothesized that SGLT2 inhibition relieves hypoxia in the kidneys. As mitochondrial dysfunction might contribute to kidney hypoxia, SGLT2 inhibition could ameliorate hypoxia via restored mitochondrial respiration. Changes in metabolic processes in peripheral blood mononuclear cells (PBMCs) are associated with various diseases including diabetes. PBMCs are an easily accessible reporter cell population to test changes in cellular metabolism caused by changes in blood glucose. The aim of this study was to investigate the effects of a single dose of 50 mg dapagliflozin compared to placebo on PBMCs’ bioenergetics in individuals with T1D in a double blinded randomized crossover study with a two-week washout period. With Seahorse extracellular flux technology, we analysed the efficiency of mitochondrial oxidative phosphorylation and glycolysis in PBMCs obtained from a fresh blood sample of each study participant before and after intervention. Fifteen individuals (33% females) with mean (±SD) age 58 (±14) years and Hba1c 8.0 (±0.6) % were included. Dapagliflozin did not influence PBMC mitochondrial oxidative phosphorylation. However, dapagliflozin significantly improved PBMC glycolytic reserve by 35% (mean ±SE, 3.5 ±0.3 e-6 ECAR/cell number) compared to baseline (2.6 ±0.5 e-6 ECAR/cell number). Our results suggest that dapagliflozin enhances PBMCs’ flexibility to use glycolysis as an energy supply pathway in individuals with T1D. This study advances our mechanistic understanding of the subtle changes in systemic metabolism and the beneficial effects at the cellular level of SGLT2 inhibition in patients with T1D. Disclosure J. Melo: None. J. Laursen: None. N. S. Heinrich: Stock/Shareholder; Self; Akebia Therapeutics, Inc., Novo Nordisk A/S. I. B. Rasmussen: None. C. S. Hansen: None. M. Frimodt-moeller: None. P. Rossing: Advisory Panel; Self; Astellas Pharma Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Merck KGaA, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Vifor Pharma Management Ltd. J. Størling: None.

Effects of Blenderized Watermelon With the Rind on Satiety, Bowel Movement, and Postprandial Glucose

Abstract Objectives Many studies have examined the beneficial effects of watermelon flesh on metabolic diseases, yet fewer studies have investigated the effects of watermelon rind. While normally discarded, rind consumption not only reduces food waste but contains fiber (pectin) and healthful bioactive compounds such as citrulline. This study examined the effects of watermelon rind consumption on postprandial glucose, satiety and bowel movements. It was hypothesized that consumption of blenderized watermelon juice with rind would lower postprandial glucose, increase satiety and improve bowel movement habits. Methods In a double-blind randomized crossover study, 21 participants (age 26.3 ± 5.7 y, BMI 22.6 ± 2.8 kg/m2) consumed one cup (8 fl. oz) of blenderized watermelon juice with or without rind. A visual analogue scale was used to measure satiety at baseline, immediately after, 20, 40, 60 and 90 minutes post juice consumption. Blood glucose was measured at baseline, 20, 40, 60 and 90 minutes post juice consumption. Bowel movement questionnaires were administered two days before and after each trial. Results Both blenderized watermelon juices (with and without rind) increased satiety with more fullness in watermelon juice with rind (P &amp;lt; 0.05). Watermelon juice with rind also stabilized blood glucose levels in comparison to watermelon juice (P &amp;lt; 0.001). No significant differences between the two trials for bowel movements were found, but no evidence of constipation or discomfort was presented among the participants. Conclusions These results suggest that watermelon juice with rind has favorable effects on postprandial glucose and satiety levels but no effect on bowel movements. Therefore, further research into the benefits of watermelon rind is important and could offer potential clinical applications and disease prevention. Funding Sources NUTR 302L Advanced Nutrition Laboratory San Diego State University and National Watermelon Promotion Board (NWPB 19–20).

Efficacy of Oral Administration of Allium sativum Powder “Garlic Extract” on Lipid Profile, Inflammation, and Cardiovascular Indices among Hemodialysis Patients

Background Inflammation plays a prominent role in the deteriorating cardiovascular risk of hemodialysis patients. Utilization of herbal remedies, especially garlic extract, in these patients has resulted in promising improvement in lipid profile, inflammation, and cardiovascular markers. Purpose In this survey, we aimed to determine the effects of oral administration of Allium sativum powder on lipid profile, inflammation, and cardiovascular markers among hemodialysis patients. Methods In this interventional double-blinded randomized crossover study, 70 patients were enrolled and assigned in two groups. Each group received 300 mg of garlic powder BID or placebo for eight weeks; after a six-week wash-out period, the agents were switched between two groups so that the group who received garlic powder in the first eight weeks received placebo for the second eight weeks, and vice versa. Venous blood samples were obtained in baseline, wash-out period, and at the end of study. Following obtaining laboratory data, BUN, creatinine, Na, K, Ca, Ph, homocysteine, and lipid profile were compared. Results No significant differences were shown at baselines of outcomes between the garlic and placebo group (p value>0.05). However, there was a significant decrease in absolute values of OXLDL (mean placebo = 979.63, mean garlic = 676.54; p value<0.001) and HCY (mean placebo = 36.54, mean garlic = 27.78; p value<0.001). In addition, significant treatment differences were seen in change values of Ca (placebo = 1.17, garlic = 0.21; p value = 0.006), TG (placebo = −6.71, garlic = -24.14; p value = 0.014), OXLDL (placebo = −281.30, garlic = -699.78; p value<0.001), and HCY (placebo = −0.24, garlic = −6.68; p value<0.001). Conclusion In this study, Allium sativum powder demonstrated efficacy in lipid profile improvement and renal protective effects among hemodialysis patients.

Wide awake at bedtime? Effects of caffeine on sleep and circadian timing in male adolescents – A randomized crossover trial

Adolescents often suffer from short and mistimed sleep. To counteract the resulting daytime sleepiness they frequently consume caffeine. However, caffeine intake may exaggerate sleep problems by disturbing sleep and circadian timing. In a 28-hour double-blind randomized crossover study, we investigated to what extent caffeine disturbs slow-wave sleep (SWS) and delays circadian timing in teenagers. Following a 6-day ambulatory phase of caffeine abstinence and fixed sleep-wake cycles, 18 male teenagers (14–17 years old) ingested 80 mg caffeine vs. placebo in the laboratory four hours prior to an electro-encephalographically (EEG) recorded nighttime sleep episode. Data were analyzed using both frequentist and Bayesian statistics. The analyses suggest that subjective sleepiness is reduced after caffeine compared to placebo. However, we did not observe a strong caffeine-induced reduction in subjective sleep quality or SWS, but rather a high inter-individual variability in caffeine-induced SWS changes. Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine. Regarding salivary melatonin onsets, caffeine-induced delays were not evident at group level, and only observed in participants exposed to a higher caffeine dose relative to individual bodyweight (i.e., a dose > 1.3 mg/kg). Together, the results suggest that 80 mg caffeine are sufficient to induce alertness at a subjective level. However, particularly teenagers with a strong need for deep sleep might pay for these subjective benefits by a loss of SWS during the night. Thus, caffeine-induced sleep-disruptions might change along with the maturation of sleep need.

Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: adouble-blind randomised crossover study using the bispectral index.

Sugammadex, a specific reversal agent for steroidal neuromuscular blocking drugs, has on occasion been reported to be associated with clinical signs of awakening. We performed a study to systematically search for an increase in bispectral index values and signs of awakening in patients maintained under general anaesthesia following sugammadex administration. Patients, scheduled to receive general anaesthesia with neuromuscular blockade, were included in this double-blind randomised crossover study. After surgery was completed, and while the train-of-four ratio was zero, intravenous anaesthesia was continued with the aim of maintaining the bispectral index in the range of 40-60. Patients then received either sugammadex 4mg.kg-1 or saline. In cases of incomplete reversal of neuromuscular blockade after 5min, patients received the other drug. Bispectral index and train-of-four monitoring were recorded every minute and clinical signs of awakening noted. Fifty-one patients completed the study. Median (IQR [range]) bispectral index values increased after sugammadex administration from 49 (43-53 [38-64]) to 63 (53-80 [45-97]) (p<0.01) with an increase of ≥20 in 22 patients; 14 (27%) patients had clinical signs of awakening. Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade. This study confirms that reversal of neuromuscular blockade with sugammadex may be associated with clinical signs of awakening despite maintenance of anaesthesia. Intravenous anaesthesia should be maintained until complete recovery of muscle function is achieved, especially when sugammadex is administered.

Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children

ObjectiveThis in situ study compared the effectiveness of two toothpastes containing hydroxyapatite or 500 ppm fluoride in promoting remineralization and inhibiting caries development.Materials and methodsTwo enamel blocks (human primary teeth), one sound and one with artificially-produced caries lesion, were exposed to toothpaste containing either 10% hydroxyapatite or 500 ppm F− (amine fluoride) via intra-oral appliance worn by 30 adults in two-arm double blind randomized crossover study lasting 14 days per arm (ClinicalTrials.gov: NCT03681340). Baseline and post-test mineral loss and lesion depth (LD) were quantified using microradiography. One-sided t-test of one group mean was used for intragroup comparison (baseline vs. post-test), while two-sided t-test of two independent means was used to compare the two toothpaste groups.ResultsPairwise comparison (baseline vs. test) indicated significant (p < 0.0001) remineralization and LD reduction by either toothpaste; however, when compared against each other, there was no statistically significant difference in remineralization or LD reduction between the two toothpastes. No demineralization could be observed in sound enamel blocks exposed to either toothpaste. While F− induced lesion surface lamination, HAP produced a more homogenous lesion remineralization.Conclusions10% hydroxyapatite achieved comparable efficacy with 500 ppm F− in remineralizing initial caries and preventing demineralization. Thus the HAP toothpaste is confirmed to be equal to the fluoride toothpaste in this study.

Effect of acute modafinil ingestion on cognitive and physical performance following mental exertion.

Modafinil is a psychostimulant that has been shown to enhance cognitive and physical performance. Given its long half-life, it may provide operational advantages if it can improve tolerance to the deleterious effects of prolonged mental exertion. Physically active males (n=13, 23±4years, peak oxygen consumption 45.3±3.2mlkg-1 min-1 ) took part in a placebo controlled, double-blind randomised crossover study to investigate if modafinil could improve cognitive and physical performance following a prolonged period of mental exertion. Overall modafinil improved performance on a task of executive function over time (p=.023; η2 =0.376) but did not improve subsequent physical endurance performance (mean difference 2.3±11.5%, p=.50), despite improvement in 10 out of the 13 participants. Task demand was reported as lower with modafinil, although perceptual measures of fatigue and motivation did not consistently improve. Heart rate during submaximal exercise was higher (134±11 vs. 119±14bpm, p<.001), and sleep was reduced (5.5±1.4 vs. 7.5±1.4hr, p<.001) and less efficient (64±13 vs. 83±9%, p<.001) compared with placebo. Operationally, modafinil may offer advantages given the established longer half-life than other psychostimulants, despite the variable response. The impact of higher heart rates and disrupted sleep on performance must also be considered.