Non-fasting Subjects Research Articles

The Impact of Ramadan Fasting on Sleep and Treatment Compliance in Psychiatric Patients: A Survey Study.

Background: During Ramadan, fasting is a duty for all healthy adult Muslims. During this month, there is a major and abrupt break in chrono-biological rhythms, sleep duration and timing, and the activity/rest cycle.
 Aims: This study aims to explore the impact of the month of Ramadan, with its various biological, behavioral, and social repercussions, on mental health in Tunisian psychiatric patients who may or may not be fasting.
 Objective: To determine the impact of the month of Ramadan on sleep and treatment compliance in psychiatric patients.
 Methods: This was a survey study of all patients under follow-up at the Monastir psychiatric outpatient department for mental disorders, with two measurements during and after the month of Ramadan in 2019 (i.e., from May 05 to June 04, 2019, the number of hours of fasting in Tunisia was between 15h 43 min and 16 h 36 min). The data was analyzed in 2020.
 Results: After studying 107 survey responses twice, during and after Ramadan, this study shows that sleep quality was significantly impaired during Ramadan for both fasters and non-fasters. There was also a significant difference between Ramadan and post-Ramadan in terms of treatment compliance; hence, adherence to treatment in the study population depended on the Ramadan effect and not the Fasting effect.
 Conclusion: This study showed that sleep quality assessed by the ISI insomnia scale was significantly impaired during the month of Ramadan for both fasting and non-fasting subjects. Also, adherence to treatment in the study population depended on the Ramadan effect and not the fasting effect.

Quantification of Cerebral Glucose Concentrations via Detection of the H1-α-Glucose Peak in 1 H MRS at 7 T.

Sensitive detection and quantification of cerebral glucose is desired. To quantify cerebral glucose by detecting the H1-α-glucose peak at 5.23 ppm in 1 H magnetic resonance spectroscopy at 7 T. Prospective. Twenty-eight non-fasted healthy subjects (aged 20-28 years). Short echo time stimulated echo acquisition mode (short-TE STEAM) and semi-localized by adiabatic selective refocusing (semi-LASER) at 7 T. Single voxel spectra were obtained from the posterior cingulate cortex (27-mL) using a 32-channel head coil. The H1-α-glucose peak in the spectrum with retrospective removal of the residual water peak was fitted using LCModel with a glucose basis set of only the H1-α-glucose peak. Conventional spectral analysis was performed with a glucose basis set of a full spectral pattern of glucose, also. Fitting precision was evaluated with Cramér-Rao lower bounds (CRLBs). The repeatability of glucose quantification via the semi-LASER sequence was tested. Paired or Welch's t-test were used for normally distributed values. A P value of <0.05 was considered significant. The repeatability of measures was analyzed using coefficient of variation (CV). Removal of the residual water peak improved the flatness and stability of baselines around the H1-α-glucose peak and reduced CRLBs for fitting the H1-α-glucose peak. The semi-LASER sequence was superior to the short-TE STEAM in the higher signal-to-noise ratio of the H1-α-glucose peak (mean ± SD 7.9 ± 2.5, P < 0.001). The conventional analysis overfitted the H1-α-glucose peak. The individual CVs of glucose quantification by detecting the H1-α-glucose peak were smaller than the corresponding CRLBs. Cerebral glucose concentration is quantitated to be 1.07 mM by detecting the H1-α-glucose peak in the semi-LASER spectra. Despite requiring long scan times, detecting the H1-α-glucose peak allows true glucose quantification free from the influence of overlapping taurine and macromolecule signals. 2 TECHNICAL EFFICACY STAGE: 1.

Effect of miswak chewing sticks on Oral Helicobacter Pylori under both fasting and non-fasting conditions – A preliminary cross-over randomized clinical trial

ObjectivesThe chewing stick or “miswak” has demonstrated growth-inhibitory effects on several oral micro-organisms including Helicobacter pylori (H. pylori). This study explores the effect of miswak on oral H. pylori among fasting and non-fasting subjects. MethodsThis cross-over randomized clinical study included 40 subjects. Twenty subjects were on 12-hour fasting and 20 subjects were not fasting. At baseline (T0), clinical periodontal parameters were recorded, and the participants were instructed on the use of toothbrush alone or toothbrush with miswak in a cross-over manner, for a period of two weeks each. Plaque and salivary samples were collected at T0, after two weeks (T1) and after 4 weeks (T2). Quantification of H. pylori from the plaque and salivary samples were performed by real-time polymerase chain reaction (qPCR). ResultsThere were 28 males and 12 females, and the mean age of the participants was 29.5 ± 7.1 years. At baseline, the median count of H. pylori was 27.61 × 103 cells/mL. The non-fasting group had significantly (p < 0.05) higher quantities of H. pylori, in both the plaque and the salivary samples, as compared with the fasting group. At T0, a statistically significant correlation was observed between the quantities of H. pylori in the dental plaque and selected clinical periodontal parameters (p < 0.05). For non-fasting subjects, a statistically significant reduction in the H. pylori counts was observed in the dental plaque samples on using miswak and toothbrush (p < 0.05). ConclusionNon-fasting subjects showed significant reduction in the H. pylori counts in dental plaque by complementing miswak chewing sticks with toothbrushing.

PENGARUH PUASA INTERMITEN MENGGUNAKAN METODE PUASA DAUD TERHADAP KADAR SGOT TIKUS PUTIH (Rattus norvegicus) ALIRAN WISTAR YANG DIINDUKSI PARACETAMOL

Background: Intermittent fasting is done with one day of fasting and one day of eating as usual so that it can reduce oxidative stress, inhibit apoptosis and tissue damage which will reduce degenerative diseases. Fasting can activate SIRT1 and SIRT3 to prevent apoptosis by decreasing reactive oxygen species and inhibiting the mitochondrial permeability transition pore component. The accumulation of free radicals is one of the mechanisms that play a role in liver damage so that the SGOT enzyme present in the liver cells will leave and enter the blood circulation, so that the number of these enzymes in the blood increases.&#x0D; Objective : To prove that there was a decrease in the levels of SGOT (Serum Glutamic Oxaloacetic Transaminase) in male white rats (Ratus norvegicus) of the wistar strain which were fasted intermittently by the Daud fasting method after being induced by Paracetamol.&#x0D; Method : The research design used is a laboratory experimental research type where the method used is randomized the post only control group design. The experimental animals used were white rats (Rattus norvegicus) wistar strain 2-3 months old with an initial body weight of 150-200gr as many as 32 tails. During the fasting treatment, the research subjects were not given diet and drinking, while the non-fasting subjects were given a standard diet and drank regularly were divided into four groups, namely negative control with a water probe that was filtered for 10 days and 1ml of 1% CMC-Na, positive control with a probe. filtered water for 10 days and induction of paracetamol 400mg/kgBW, treatment 1 with standard diet and induction of paracetamol and treatment 2 with intermittent fasting and induction of paracetamol.&#x0D; Results: The results of this study indicate that One-Way ANOVA test obtained p value = 0.384. (p &gt; 0.05) then H0 was accepted, there was no significant difference between the SGOT levels of the experimental animal group that was given a standard diet, the experimental animal group that was given intermittent fasting, the experimental animal group that was given a standard diet and paracetamol and the experimental animal group that was given intermittent fasting and paracetamol treatment.&#x0D; Conclusion: There is no effect of intermittent fasting with the Dawood fasting method on decreasing SGOT levels in male white rats (Rattus norvegicus) Wistar strain induced by paracetamol.&#x0D; Keywords: intermittent fasting, SGOT, paracetamol

Serum metabolomic biomarkers of perceptual speed in cognitively normal and mildly impaired subjects with fasting state stratification

Cognitive decline is associated with both normal aging and early pathologies leading to dementia. Here we used quantitative profiling of metabolites involved in the regulation of inflammation, vascular function, neuronal function and energy metabolism, including oxylipins, endocannabinoids, bile acids, and steroid hormones to identify metabolic biomarkers of mild cognitive impairment (MCI). Serum samples (n = 212) were obtained from subjects with or without MCI opportunistically collected with incomplete fasting state information. To maximize power and stratify the analysis of metabolite associations with MCI by the fasting state, we developed an algorithm to predict subject fasting state when unknown (n = 73). In non-fasted subjects, linoleic acid and palmitoleoyl ethanolamide levels were positively associated with perceptual speed. In fasted subjects, soluble epoxide hydrolase activity and tauro-alpha-muricholic acid levels were negatively associated with perceptual speed. Other cognitive domains showed associations with bile acid metabolism, but only in the non-fasted state. Importantly, this study shows unique associations between serum metabolites and cognitive function in the fasted and non-fasted states and provides a fasting state prediction algorithm based on measurable metabolites.

Evaluation of the effect of fasting on intraocular pressure, anterior segment parameters and density of crystalline lens and cornea.

To evaluate the effect of fasting on anterior chamber depth, anterior chamber volume and corneal and lens density by Scheimpflug technology and to measure intraocular pressure changes. Totals of 50 healthy fasting individuals in Ramadan (study group) and 50 healthy non-fasting subjects (control group) were included. Central corneal thickness (CCT), anterior chamber depth (ACD), anterior chamber volume (ACV), corneal density (CD) and lens density (LD) were evaluated with Scheimpflug technology. Intraocular pressure (IOP) was measured with applanation tonometry. Both eyes of each participant were examined and also compared. Comparison of groups: There was a statistically significant difference between CD, ACD, ACV and IOP (respectively, right/left eye: fasting: CD: 12.81 ± 0.76/12.73 ± 0.73; ACD: 2.92 ± 0.37mm/2.93 ± 0.37mm; ACV: 168.3 ± 41.82mm3/183.34 ± 32.46mm3; IOP: 13.80 ± 1.22mmHg/14.88 ± 2.73mmHg; non-fasting: CD: 13.28 ± 1.01/13.17 ± 0.77; ACD: 3.06 ± 0.31mm/3.07 ± 0.31mm; ACV: 167.46 ± 42.92mm3/180.68 ± 31.45mm3; IOP: 13.60 ± 1.65mmHg/14.74 ± 2.93mmHg) values on the right side (p < 0.01, p = 0.03, p = 0.04, p = 0.01, respectively). Although there was a statistically significant difference between the ACV, CD and IOP values on the left side (p < 0.01, p = 0.03, p = 0.01, respectively), no statistical significance was found for the ACV value on the left side (p = 0.08). The results demonstrated that, while fasting did not lead to any change in LD and CCT, it caused a small decrease in ACD and ACV, and a significant decrease in CD and IOP values. Scheimpflug technology seems to be a valuable tool for the evaluation of anterior segment changes in patients who are fasting.

Serum zinc levels in apparently healthy children in Nigeria: Are they acceptable

Introduction:Despite the importance of zinc in the human body, there is paucity of data on the zinc status of Nigerian children. The aim of this study was to determine the serum zinc levels of children attending the pediatric outpatient clinic of a tertiary hospital in South East Nigeria and to assess their need for routine zinc supplementation.Materials and Methods:One hundred children aged 5–60 months were recruited consecutively from the pediatric outpatient clinic. Their socioeconomic class (SEC) was assessed using the tool developed by Oyedeji. Physical examination was carried out to exclude malnutrition and/or liver disease. Samples were collected in the morning from nonfasting subjects and were analyzed using atomic absorption spectrophotometer. Serum zinc deficiency was defined as zinc level <80 μg/dl.Results:The overall median (range) serum zinc level was 83.3ug/dl (60–105 μg/dl) while the median (mean rank) serum zinc levels among male and female subjects were 83.4 μg/dl and 84.2ug/dl, respectively (U = 1071.00; P = 0.228). A total of 26 (26%) apparently healthy children had low serum zinc levels. There was no association between gender and serum zinc levels (χ2 = 2.163; P = 0.141). A significant positive but weak relationship was found between SEC and zinc levels (r = 0.208, P = 0.038) but not between serum zinc levels and age of the children (r = 0.185, P = 0.065).Conclusion:A significant proportion of Under-5s could have low serum zinc levels. Routine zinc supplementation may be necessary among this age group in Nigeria.

Effects of Ramadan Fasting on the Symptoms of Gastroesophageal Reflux Disease

Introduction: The effects of Ramadan fasting on gastroesophageal reflux disease (GERD) remains unknown, and few studies have been conducted in this regard. The nutritional, physiological, psychological, and behavioral changes in fasting individuals during Ramadan may affect the status of GERD. The present study aimed to evaluate the effects of these changes on the symptoms of GERD using a meticulous method. Methods: This study was conducted on patients with clinically diagnosed GERD by a gastroenterologist, who was followed-up for three consecutive months (from one month before to after Ramadan). Data were collected using GERD health-related quality of life (GERD-HRQL).For ethical considerations; antisecretory drugs were prescribed for all the patients. After data collection, the subjects were divided into two groups of fasting and non-fasting. Data analysis and comparison were performed in SPSS. Results: total, 69 patients with GERD completed the follow-up, including 33 fasting and 36 non-fasting subjects. No significant differences were observed in the changes of the Total, Heartburn and Regurgitation scores between the Fasting and Non-fasting groups from before Ramadan to Ramadan, Ramasdan to after Ramadan and also before to after Ramadan (P>0.05). Conclusion: According to the results, Ramadan fasting has no effects on the symptoms of GERD in the patients using antisecretory drugs during this month.

Detecting Gastric Contents by Electronic Nose Device Analysis of Exhaled Volatile Organic Compounds

Introduction: Though rare, aspiration events during endoscopy are associated with serious consequences. Furthermore, the presence of significant gastric contents can lead to aborted procedures, reducing endoscopy suite efficiency. However, there is no current system to determine if a patient has gastric contents prior to a sedated procedure, other than inquiries regarding timing of their last meal. We previously piloted the use of a first generation electronic nose device to detect the presence of gastric contents via exhaled volatile organic compounds (VOC's). Here we present the development of a testing program for gastric contents using an improved second generation electronic nose device. Methods: Patients provided 5-minute breath samples into a second generation Aeonose electronic nose (Aeonose, eNose Company, Zutphen, NL). Breath samples were collected from two groups: Group 1 was subjects fasting for gastrointestinal endoscopy; Group 2 was subjects who had eaten a meal 30 to 120 minutes before providing a sample. The Aeonose device analyzes a breath sample over 5-minutes. During this time the patient's breath is circulated over a metal-oxide sensor array. VOC's in the breath sample cause reduction-oxidation reactions in the sensor array. These reactions cause changes in the conductance of circuits that run through the sensor and in the temperature of the sensor array. The Aeonose device measures these changes over time to create a 3-D digital signature of each breath sample. These digital signatures are uploaded into an artificial neural network. This network performs pattern recognition analysis between breath samples from fasting and non-fasting subjects. Results: Breath samples were obtained from a total of 96 individuals; 50 fasting and 46 non-fasting. Optimal multivariate modeling developed a predictive model for the fasting state with performance characteristics of 80% sensitivity, 70% specificity, 75% accuracy and AUC=0.75 (Figure 1). The positive predictive value for fasting state was 74%. The tests negative predictive value was 76%. The Matthews Correlation Coefficient was 0.50.Figure: Detection of Gastric Contents via Electronic Nose Predictive Model Receiver Operating Curve.Conclusion: The second-generation Aeonose electronic-nose provides fair discrimination between a patient in a fasting state (no gastric contents) and a patient in a non-fasting state (present gastric contents). Given the lack of a validated tool to determine the presence of gastric contents, the significant harm gastric contents can cause in sedated procedures, and the low cost, non-invasive nature of electronic nose testing, this study suggests the Aeonose device can be used as a screening tool to identify patients with retained gastric contents prior to sedated procedures. The point of care nature of this testing would allow for an alteration in care to improve procedure safety and efficiency. Further work to refine the model and improve the tests efficiency is ongoing. A validation study is also in progress.

Whole blood glycerophospholipids in dried blood spots − a reliable marker for the fatty acid status

BackgroundWhole blood total fatty acid analysis in capillary blood has recently been proposed for fatty acid status determination, but the accuracy of this method is affected by the fast turnover of triaclyglyceride (TAG) fatty acids, the individual hematocrit and postprandial state. MethodAn established method for the glycerophospholipid (GPL) analysis in plasma was adapted for the analysis of whole blood GPL and tested in a fat challenge test. Blood samples were collected from nine participants after receiving a standardised breakfast containing 42g of sunflower oil. Whole blood GPL fatty acids were compared against whole blood total lipid, plasma TAG and phospholipid fatty acids. ResultsAll fatty acid concentrations in dried blood samples showed a coefficient of variation <5.7%. The fat challenge test induced a significant increase of TAG fatty acid concentration (mean Δ=42.3%±35.7) and whole blood total fatty acid concentration (mean Δ=5.2%±3.7) whereas whole blood GPL fatty acids were hardly changed (mean Δ=1.3%±1.6). ConclusionWhole blood GPL fatty acids are a robust biological marker for the fatty acid status of fasted and non-fasted subjects. The influence of very recent dietary intake on whole blood GPL is smaller than on whole blood total lipids.

The Effect of Dehydration and Fasting on Corneal Biomechanical Properties and Intraocular Pressure.

To evaluate the changes in corneal biomechanical properties and intraocular pressure (IOP) during fasting period in healthy subjects. Seventy-two eyes of 72 fasting subjects (study group), and 62 eyes of 62 nonfasting subjects (control group) were enrolled in this prospective study undertaken at a single university hospital. All subjects underwent complete ophthalmologic examination including ocular biomechanical evaluation with ocular response analyzer. Ocular response analyzer measurement was performed on the right eyes of the subjects between 5.00 and 6.00 PM after approximately 14 hr of fasting for the study group and after a nonfasting period for the control group. The corneal hysteresis, corneal resistance factor, mean corneal compensated IOP (IOPcc), and Goldmann-correlated IOP (IOPg) values were measured with a patented dynamic bidirectional applanation process. Goldmann-correlated IOP and IOPcc measurements in the study group and the control group were found as 13.8±2.8 mm Hg, 14.6±2.6 mm Hg and 16.3±2.2 mm Hg, 15.7±2.4 mm Hg, respectively. There was statistically significant difference within the two groups in IOPg and IOPcc (P<0.001). In addition, corneal hysteresis and corneal resistance factor significantly decreased in study group compared with control group (P<0.001, P=0.012, respectively). Prolonged fasting causes a significant decrease in IOPg, IOPcc, corneal hysteresis, and corneal resistance factor in healthy subjects, altering the biomechanical properties of the cornea.

Pharmacokinetics of oral amantadine in greyhound dogs

This study reports the pharmacokinetics of amantadine in greyhound dogs after oral administration. Five healthy greyhound dogs were used. A single oral dose of 100mg amantadine hydrochloride (mean dose 2.8mg/kg as amantadine hydrochloride) was administered to nonfasted subjects. Blood samples were collected at predetermined time points from 0 to 24h after administration, and plasma concentrations of amantadine were measured by liquid chromatography with triple quadrupole mass spectrometry. Noncompartmental pharmacokinetic analyses were performed. Amantadine was well tolerated in all dogs with no adverse effects observed. The mean (range) amantadine CMAX was 275ng/mL (225-351ng/mL) at 2.6h (1-4h) with a terminal half-life of 4.96h (4.11-6.59h). The results of this study can be used to design dosages to assess multidose pharmacokinetics and dosages designed to achieve targeted concentrations in order to assess the clinical effects of amantadine in a variety of conditions including chronic pain. Further studies should also assess the pharmacokinetics of amantadine in other dog breeds or using population pharmacokinetics studies including multiple dog breeds to assess potential breed-specific differences in the pharmacokinetics of amantadine in dogs.

What is it about very low density lipoproteins (VLDL) and cardiovascular disease in patients with type 2 diabetes mellitus: Is it the triglycerides or the cholesterol?

Evidence continues to support a relationship between fastingand non-fasting plasma triglycerides (TG) and coronary heart dis-ease (CHD), but is it the triglycerides that are causative or is it thelipid/lipoprotein company they keep, e.g. reductions in HDLcholesterol [1]. And in patients with type 2 diabetes, a populationwherein hypertriglyceridemia is more common [2,3], plasma TGappear to be an important contributor to CVD risk [4,5]. This as-sociation could very well be causal; the major TG-containing lipo-protein in fasted subjects is very low density lipoproteins (VLDL)and to a lesser extent intermediate density lipoproteins (IDL)(d > 1.006 but 0. Moreover, a CAC score distribution is not provided and thereproducibility of the method is not stated. Thus, a comparison oftwo scans may have revealed one at 0 and another >0, e.g. 8. Ac-cording to the method by which scores were calculated (Agatston),thespecificityofaCAC score of1wasreportedas61%but increasedto 87% at 25 [9]. Moreover, the validation studies of Hokanson et al.[10]indicatethata cut-pointof 6.25 provided >99% certainty thatthe CAC score is not 0. With values <6.25 one cannot reliably statetheCACscore isdifferentthan0.Inaddition,ithasalsobeenshownthat a cut-point of 6.25 to define progression of CAC is the bestpredictor of future mortality compared to other methods ofassessing CAC [11]. Perhaps the unacceptably low threshold forpositivity used in PDHS could have influenced the VLDL-C/CACresults?The stronger relationship between VLDL-C and CAC in womenthan men extends previous observations that suggested a strongerassociation of hypertriglyceridemia with coronary heart disease(CHD) risk in women than men. In the 1980s data from Framing-ham demonstrated a more robust relationship between fastingplasma TG with cardiovascular disease (CVD) events in womenthan men [12]. And, more recent analyses have confirmed astronger relationship of both fasting and non-fasting plasma TGwith CVD in women than men [13]. However, despite the conve-nience of non-fasting vs. fasting plasma TG and a similar if notbetter CVD risk prediction of non-fasting than fasting values [14],the most recent ACC/AHA Cholesterol Guideline is based on lipidsmeasured in fasted not non-fasted subjects [15,16].An expected relationship between plasma VLDL-C and TG wasfound (r ¼ 0.88, P < 0.0001), yet using Akaike information criteriaand Bayesian information criteria the authors provide evidence to

Fasting increases serum bilirubin levels in clinically normal, healthy males but not females: a retrospective study from phase I clinical trial participants

AimTo examine if fasting affects serum bilirubin levels in clinically healthy males and females.MethodsWe used retrospective data from phase I clinical trials where blood was collected in either a fed...

A New Metabolomic Signature in Type-2 Diabetes Mellitus and Its Pathophysiology

ObjectiveThe objective of the current study was to find a metabolic signature associated with the early manifestations of type-2 diabetes mellitus.Research Design and MethodModern metabolic profiling technology (MxP™ Broad Profiling) was applied to find early alterations in the plasma metabolome of type-2 diabetic patients. The results were validated in an independent study. Eicosanoid and single inon monitoring analysis (MxP™ Eicosanoid and MxP™ SIM analysis) were performed in subsets of samples.ResultsA metabolic signature including significantly increased levels of glyoxylate as a potential novel marker for early detection of type-2 diabetes mellitus was identified in an initial study (Study1). The signature was significantly altered in fasted diabetic and pre-diabetic subjects and in non-fasted subjects up to three years prior to the diagnosis of type-2 diabetes; most alterations were also consistently found in an independent patient group (Study 2). In Study 2 diabetic and most control subjects suffered from heart failure. In Study 1 a subgroup of diabetic subjects, with a history of use of anti-hypertensive medication further showed a more pronounced increase of glyoxylate levels, compared to a non-diabetic control group when tested in a hyperglycemic state. In the context of a prior history of anti-hypertensive medication, alterations in hexosamine and eicosanoid levels were also found.ConclusionA metabolic signature including glyoxylate was associated with type-2 diabetes mellitus, independent of the fasting status and of occurrence of another major disease. The same signature was also found to be associated with pre-diabetic subjects. Glyoxylate levels further showed a specifically strong increase in a subgroup of diabetic subjects. It could represent a new marker for the detection of medical subgroups of diabetic subjects.

Untargeted Lipidomic Profiling of Human Plasma Reveals Differences due to Race, Gender and Smoking Status

Lipidomic profiling can link genetic factors and exposures to risks of chronic diseases. Using untargeted liquid chromatography-Fourier Transform mass spectrometry (LC-FTMS), we explored differences in 3,579 lipidomic features in human plasma from 158 non-fasting subjects, pooled by race, gender and smoking status. Significant associations with race (23 features), smoking status (9 features) and gender (2 features) were detected with analysis of variance (ANOVA)-based permutation tests. Identities of several features were confirmed as plasmalogens (vinyl-ether phospholipids) that were present at 2-fold greater concentrations in black subjects. Other putative features, based on accurate masses, were more abundant in white subjects, namely, dihomo-γ-linolenoyl ethanolamide (DGLEA), an endogenous endocannabinoid receptor agonist and a glycerophosphocholine [PC(16:0/18:1)]. After adjustment for race, multivariable linear regression models showed that gender was significantly associated with levels of plasmalogens and DGLEA and that consumption of animal fat was marginally associated with concentrations of plasmalogens. Interestingly, BMI did not explain additional variability in any race-adjusted model. Since plasmalogens are antioxidants that are generally regarded as health-promoting and DGLEA is an agonist of the cannabinoid receptor, our findings that these molecules differ substantially between black and white Americans and between men and women, could have health implications. The concentration of cotinine was greatly elevated in smoking subjects and 6 features with m/z values suggestive of phospholipids or sphingomyelins were present at significantly lower concentrations in smokers.

Vitamin D Intake and Status Are Associated with Lower Prevalence of Metabolic Syndrome in U.S. Adults: National Health and Nutrition Examination Surveys 2003–2006

Previous reports have shown that metabolic syndrome and some metabolic syndrome components are associated with serum 25-hydroxyvitamin D [25(OH)D]. Using the National Health and Nutrition Examination Surveys (NHANES), 2003-2006, we evaluated the associations of vitamin D intake (n=3543) and vitamin D status [25(OH)D; n=3529], with the prevalence of metabolic syndrome and its components in adults 20 years and older. Exclusion criteria included nonfasted subjects, those pregnant and/or lactating, and, for intake analyses, those with unreliable 24-h recall records. Subjects were separately classified into quartiles of vitamin D intake (both including and excluding supplements) and serum 25(OH)D. Logistic regression was used to determine odds ratios (OR) for metabolic syndrome after adjusting for multiple confounders. Those in the highest quartile of serum 25(OH)D had 60% lower odds for metabolic syndrome as compared to those in the lowest quartile [OR=0.40; 95% confidence interval (CI) 0.27, 0.59]. Elevated waist circumference (OR=0.57; 95% CI 0.39, 0.84), low high-density lipoprotein cholesterol (HDL-C) (OR=0.54; 95% CI 0.39, 0.75), and high homeostasis model assessment of insulin resistance (HOMA-IR) (OR=0.40; 95% CI 0.29, 0.55) were the main components associated with serum 25(OH)D. Compared with the lowest vitamin D intake quartile (excluding supplements), those in the highest intake quartile had 28% lower odds for metabolic syndrome (OR=0.72; 95% CI 0.58, 0.90). No components of metabolic syndrome were significantly associated with dietary intake of vitamin D with supplements included or excluded. We conclude that higher 25(OH)D, and, to a lesser degree, greater dietary vitamin D intake, are associated with reduced prevalence of metabolic syndrome.

Measurement of C-terminal telopeptide of type I collagen (CTX) in serum

Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone. Assay reagents are available in manual and automated formats and give good analytical performance. However their standardisation is not transparent and significant differences in results between methods have been demonstrated. CTX is most stable in EDTA plasma, although serum samples processed promptly would be satisfactory. sCTX shows a profound circadian rhythm, especially in non-fasting subjects; specimens should be collected from fasting patients at a well-defined time of day to minimise biological variation. Reference intervals in pre-menopausal women have been well studied but in other adult groups there is less information. Healthy children show the expected age-related variation corresponding to growth rate. Serum CTX fulfils or partially fulfils all the criteria of a reference bone turnover marker. Further studies aimed at reducing inter-method differences in results and establishing the relationships of sCTX with fracture risk and with fracture risk improvement with treatment are required.

Single-dose pharmacokinetics and safety of iptakalim hydrochloride in Chinese healthy volunteers

To investigate the safety, pharmacokinetics and food effect of iptakalim in healthy adult Han Chinese volunteers. Study 1 was a randomized open-label, Latin square designed, single-dose, three-period, self-control crossover study. Six men and six women received 5, 10 and 20 mg of iptakalim orally. Study 2 was a randomized, open-label, single-dose, two-period, self-control crossover study. Ten men were included and each subject received 5 mg iptakalim orally, fasting and nonfasting. No adverse effects were reported and no clinically meaningful changes in vital signs were found. Cmax, AUC(0-t) and AUC(0-∞) were proportional over the dose levels of 5, 10 and 20 mg. Tmax, t½ and CL/F were similarly independent of dose level. In the 5 mg and 20 mg group, the Cmax, AUC(0-t) and AUC(0-∞) in women were significantly higher than in men, although they showed no difference after correction by mg/kg doses in the 5 mg group. At the 5-mg dose level, no significant difference in pharmacokinetics was found in nonfasting and fasting subjects. Single-dose pharmacokinetics of iptakalim showed dose proportionality over the dose levels of 5-20 mg. The pharmacokinetics showed gender differences in the 5 and 20 mg groups. Food had almost no impact on the pharmacokinetics at the 5 mg level.

Pharmacokinetics and safety of calcium L-threonate in healthy volunteers after single and multiple oral administrations

To evaluate the pharmacokinetics of L-threonate after single or multiple oral administrations and its safety profile in healthy Chinese volunteers. This was an open-label, single- and multiple-dose study. The subjects were assigned to receive a single dose, 675, 2025, or 4050 mg, of calcium L-threonate (n=12) or repeated doses of 2025 mg twice daily for 4 d (n=12). Serial plasma and urine samples were analyzed with HPLC-MS/MS. Pharmacokinetic parameters of L-threonate were calculated using non-compartmental analysis with WinNonlin software. In the single dose group, C(max) reached at 2.0 h and the mean t(1/2) was approximately 2.5 h. Area under curve (AUC) and C(max) increased with dose escalation, but dose proportionality was not observed over the range of 675 to 4050 mg. AUC and C(max) in the fasted subjects were lower compared with those in the non-fasted subjects. Cumulative urinary excretion of L-threonate over 24 h represented 5.9% of the administered dose with a mean Cl/r of 0.8 L/h. In the multiple-dose study, no accumulation appeared upon repeated doses of 2025 mg twice daily for 4 d. There were no serious adverse events that occurred during this study. Calcium L-threonate was well tolerated in healthy Chinese subjects, with no pattern of dose-related adverse events. Plasma exposure increased with dose escalation, but linear pharmacokinetics were not observed over the studied doses. L-threonate was absorbed rapidly, and its absorption was enhanced by food intake. No systemic accumulation appeared after repeated administrations.