Journal of Dietary Supplements最新文献

Exogenous melatonin can be helpful for treatment of some sleep disorders. However, immediate-release formulations are rapidly absorbed and cleared from the body making it difficult to provide coverage for an entire sleep period. Extended-release melatonin formulations can better mimic the naturally occurring melatonin profile and increase efficacy, but few studies have reported on their pharmacokinetics. To assess the pharmacokinetics of extended-release melatonin, we conducted a randomized, double-blind, crossover study of extended-release melatonin (4 mg) compared to immediate-release melatonin (4 mg) in 18 healthy adults, ages 18-65 years. Participants received immediate-release or extended-release melatonin in clinic after an 8 h fast, and blood samples were taken over a 10-h period. After a 7-day washout period, the same procedures were repeated with the melatonin form not previously received. Extended-release melatonin had a longer time to peak concentration (1.56 vs 0.6 h) and elimination half-life (1.63 vs 0.95 h) compared with immediate-release melatonin. Maximum concentration was lower for extended-release melatonin compared with immediate-release melatonin (7581 pg/mL vs 13120 pg/mL). Extended-release melatonin raised melatonin levels in as little as 15 min and sustained elevated melatonin levels (>300 pg/mL) for 6 h before falling below 50 pg/mL by 9 h. No clinically relevant adverse events were observed, and safety parameters remained within normal ranges for both formulations. The pharmacokinetic profile of this extended-release melatonin formulation suggests that it could be used for future efficacy studies of melatonin and sleep outcomes. This trial is registered at ClinicalTrials.gov, NCT04067791.

The rampant use of antibiotics has led to the emergence of multidrug resistance and is often coupled with gut dysbiosis. To circumvent the harmful impact of antibiotics, probiotics have emerged as an effective intervention. However, while the new probiotics are being added to the list, more recently, the nature and role of their counterparts, viz. prebiotics, postbiotics and parabiotics have also drawn considerable attention. As such, intricate relationships among these gut-biotics vis-à-vis their role in imparting health benefits is to be delineated in a holistic manner. Prebiotic dietary fibers are selectively fermented by probiotics and promote their colonization in the gut. The proliferation of probiotics leads to production of fermentation by-products (postbiotics) which affect the growth of enteropathogens by lowering the pH and producing inhibitory bacteriocins. After completing life-cycle, their dead remnants (parabiotics e.g. exopolysaccharides and cell wall glycoproteins) also inhibit adhesion and biofilm formation of pathogens on the gut epithelium. These beneficial effects are not just endemic to gut but a systemic response is witnessed at different gut-organ axes. Thus, to decipher the role of probiotics, it is imperative to unravel the interdependence between these components. This review elaborates on the recent advancements on various aspects of these gut-biotics and the mechanism of potential attributes like anti-oxidant, anti-inflammatory, anti-neoplastic, anti-lipidemic and anti-hyperglycemic benefits.

Present study aimed compared pharmacokinetic profile of sustained-release CaffXtend® capsules (SR-Caffeine) with immediate-release caffeine capsules (IR-Caffeine), and the effect of SR-caffeine on memory, motivation, concentration, and attention. This open-label, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover oral bioavailability study block randomized (1:1) healthy subjects (N = 15) to receive SR-Caffeine (200 mg) and IR-Caffeine (200 mg). Blood samples were collected at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 h in each period. Primary study outcome included comparing relative bioavailability of SR-Caffeine 200 mg and IR-Caffeine 200 mg under fasting conditions, and changes in caffeine research visual analogue scale (Caff-VAS) scores ('relaxed', 'alert', 'jittery', 'tired', 'tense', 'headache', 'overall mood' and 'mentally fatigued') were also evaluated. Fifteen subjects completed the study. Mean t_max was 4.08 ± 2.13h for SR-Caffeine compared to 0.83 ± 0.39h for IR-Caffeine, (p < 0.0001). Similarly, mean t_½ was 7.07 ± 3.48h for SR-Caffeine compared to 5.78 ± 2.11h for IR-Caffeine (p = 0.04189). However, total exposure was similar for SR-Caffeine and IR-Caffeine (90% CI: 89.89-120.50% to 94.49-123.82% for geometric least square mean of ln-transformed AUC_0-t and AUC_0-∞). In the Caff-VAS evaluation, the SR-Caffeine group showed significantly better scores for 'jitteriness', 'tiredness', 'alertness' and 'overall mood' for 8-12 h than the IR-Caffeine group. No adverse events were reported. Results demonstrated sustained release of caffeine over 24 h from SR-Caffeine as compared to IR-Caffeine, which showed significant improvements in the scores for 'relaxed', 'alertness' and 'overall mood' and significantly lower scores for the parameters-'jittery' and 'tired' for extended period.Clinical trial registration: CTRI/2021/06/034185.

Monoclonal antibody Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors reduce total cholesterol (TC), low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (TG). We assessed the ability of berberine, a natural PCSK9 inhibitor, to reduce lipid concentrations either alone or combined with other nutraceuticals. We searched PubMed, Scopus and EMBASE from inception to September 30^th, 2022 for randomized controlled trials (RCTs) assessing 8-18 wk of berberine therapy on. A total of 41 RCTs with 4,838 patients met our inclusion criteria. Berberine containing products significantly reduced TC (MD -17.42 mg/dL [95%CI: -22.91 to -11.93]), LDL (MD -14.98 mg/dL [95%CI: -20.67 to -9.28]), and TG (MD -18.67 mg/dL [95%CI: -25.82 to -11.51]) while raising HDL (MD 1.97 mg/dL [95%CI: 1.16 to 2.78]) versus control (I² > 72% for all analyses). Products with berberine alone had less robust effects on TC (MD -12.08 mg/dL [95%CI: -21.79 to -2.37]), LDL (MD -9.26 mg/dL [95%CI: -20.31 to 1.78]), and HDL (MD 1.38 mg/dL [95%CI: -1.27 to 4.03]) but TG effects were similar (MD -17.40 mg/dL [95%CI: -32.57 to -2.23]). Berberine along with red yeast rice reduced TC (MD -19.62 mg/dL [95%CI: -28.56 to -10.68]) and LDL (MD -18.79 mg/dL [95%CI: -28.03 to -9.54]) as did combination therapy with Silybum maranium for TC (MD -31.81 mg/dL [95%CI: -59.88 to -3.73]) and LDL (MD -30.82 mg/dL [95%CI: -56.48 to -5.16]). Berberine, alone or with other nutraceuticals, can provide a modest positive impact on lipid concentrations.

This study investigated the effects of chlorella supplementation on submaximal endurance, time trial performance, lactate threshold, and power indices during a repeated sprint performance test by fourteen male trained cyclists. Participants ingested 6 g/day of chlorella or placebo for 21-days in a double-blinded randomized counter-balanced cross-over design, with a fourteen-day washout period between trials. Each completed a 2-day testing period comprising a 1-hour submaximal endurance test at 55% external power output max and a 16.1 km time trial (Day-1), followed by a lactate threshold (Dmax) and repeated sprint performance tests (3 X 20 s sprints interspersed by 4-mins) (Day-2). Heart rate (b^.min^-1), RER, V̇O₂ (ml·kg^-1·min^-1), lactate and glucose (mmol/L), time (secs), power output (W/kg), and hemoglobin (g/L) were compared across conditions. Following chlorella supplementation (chlorella vs. placebo for each measurement) average lactate and heart rate were significantly lower (p < 0.05) during submaximal endurance tests (1.68 ± 0.50 mmol/L vs. 1.91 ± 0.65 mmol/L & 138 ± 11b^.min^-1 vs. 144 ± 10b^.min^-1), average power and peak power (W/kg) were significantly higher during repeated sprint bouts (9.5 ± 0.7 W/kg vs. 9.0 ± 0.7 W/kg & 12.0 ± 1.2 W/kg vs. 11.4 ± 1.4 W/kg), hemoglobin significantly increased (149.1 ± 10.3 g/L) in comparison to placebo (143.4 ± 8.7 g/L) (p = 0.05). No differences existed between conditions for all oxygen consumption values, 16.1 km time trial measures and lactate threshold tests (p > 0.05). In conclusion, chlorella may pose as an additional supplement for cyclists to consider, particularly for those cyclists who want to improve their sprinting.

Introduction: Health inequities and disparities in nutrition research exist among transmasculine people. A dearth of evidence on dietary supplement use and motivations exist, partially due to constrained collection of sex and gender identity in national surveys.

Objective: We sought to investigate common motivations and use of dietary supplements in a voluntary survey of transmasculine people.

Methods: A total of 48 participants completed an online survey detailing dietary supplement use, motivations, and demographic information.

Results: 64.5 and 90.0% of participants reported use of 1+ dietary supplement within the past 30-days and during some point in their lifetime, respectively. Top reported product types used included multivitamins (52%), melatonin (52%), vitamin D (46%), vitamin C (35%), fish oil (33%), B-vitamins or B-complex (31%), iron (29%), green tea (29%), biotin (25%), cranberry (23%), zinc (23%), protein powder (23%), probiotics (23%), and calcium (21%). There was no relationship between the number of supplements reported and participant age, BMI, income, or mastectomy status (p > 0.05). Participants reported top motivations being for "improving my overall health" (60.4%), "maintaining health" (54.2%), to "supplement my diet due to not getting enough from food"(41.7%), "mental health" (39.6%), and to "prevent colds, boost immune system" (33.3%).

Conclusion: Transmasculine people in our study reported a high use of dietary supplements. Differences in the types of products and number of products used, as well as specific motivations for use likely exist within this subpopulation, however, future nationally-representative longitudinal studies are needed to fully elucidate these patterns and for informing evidence-based nutrition guidance.

Prebiotic and probiotic combinations may lead to a synbiotic effect, demonstrating superior health benefits over either component alone. Using the Mucosal Simulator of the Human Intestinal Microbial Ecosystem (M-SHIME^®) model, the effects of repeated supplementation with inulin (prebiotic, which is expected to provide a source of nutrition for the live microorganisms in the gut to potentially support optimal digestive health), Bacillus coagulans lactospore (probiotic), and a low and high dose of a synbiotic combination of the two on the gut microbial community activity and composition were evaluated. Test product supplementation increased the health-promoting short-chain fatty acids acetate and butyrate compared with levels recorded during the control period, demonstrating a stimulation of saccharolytic fermentation. This was likely the result of the increased abundance of several saccharolytic bacterial groups, including Megamonas, Bifidobacterium, and Faecalibacterium, following test product supplementation. The stimulation of acetate and butyrate production, as well as the increased abundance of saccharolytic bacterial groups were more evident in treatment week 3 compared with treatment week 1, demonstrating the value of repeated product administration. Further, the synbiotic formulations tended to result in greater changes compared with prebiotic or probiotic alone. Overall, the findings demonstrate a synbiotic potential for inulin and B. coagulans lactospore and support repeated administration of these products, indicating a potential for promoting gut health.

This study aimed to investigate the effects of 12-week consumption of highly bioavailable curcumin (150 mg/day of Theracurmin Super [TS-P1] or Theracurmin [CR-033P]) on common cold symptoms, immune function, and inflammatory markers. A randomized, double-blind, placebo-controlled study was conducted from November 2021 to May 2022 on 99 healthy Japanese adults. Using a computerized random number generator, each subject was randomly assigned to one of the following three groups: TS-P1, CR-033P, or placebo (n = 33 per group). For 12 weeks, each group consumed the four capsules that were given to them daily. The cumulative number of days for which common cold symptoms persisted was set as the primary outcome. Immunity parameters, inflammatory parameters, liver function parameters, and physical examination results were additional outcomes. A safety assessment was also performed. Ninety-four subjects completed the study, and the per protocol set included 30 subjects in the placebo group, 32 subjects in the TS-P1 group, and 33 subjects in the CR-033P group. The cumulative number of days for which common cold symptoms persisted was significantly lower in the TS-P1 and CR-033P groups than that in the placebo group. No adverse effects were observed. Consumption of highly bioavailable curcumin, TS-P1 or CR-033P (150 mg/day), for 12 weeks reduced the number of days for which common cold symptoms persisted in healthy Japanese adults.

Nonalcoholic fatty liver disease (NAFLD) is a prominent etiological factor for liver cirrhosis worldwide. It is frequently associated with obesity, diabetes, dyslipidemia, and hypertension. The objective of this study is to assess the efficacy and safety of ginger (Zingiber officinale Roscoe) supplementation in patients with type 2 diabetes mellitus (T2DM) who have NAFLD. In a two-arm, double-blind, placebo-controlled clinical trial, seventy-six patients diagnosed with both T2DM and NAFLD were randomly assigned to receive either ginger powder capsules (1000 mg, twice daily) or placebo capsules (administered in the same manner) for a period of three months. Anthropometric measurements, blood pressure readings, biochemical profiles, and imaging parameters were assessed before and after the intervention. Safety measures were also evaluated. In both the ginger and placebo groups, there was a significant reduction in mean body mass index (BMI), waist and hip circumferences, as well as liver transaminase levels. Moreover, significant improvements in mean systolic and diastolic blood pressures were observed in the ginger group (p = 0.02 and < 0.0001, respectively). Within the ginger group, there was a decrease in serum insulin levels and insulin resistance (HOMA-IR) (p = 0.002 and 0.004, respectively). Furthermore, the ginger group exhibited an improvement in serum HDL-cholesterol level (p = 0.01). However, there were no significant changes in the assessed inflammatory markers or the indices obtained from fibroscan imaging, including steatosis percent and controlled attenuation parameter. This study demonstrates that ginger supplementation can significantly improve mean systolic and diastolic blood pressures. However, it does not have a significant impact on inflammatory markers or fibroscan imaging indices. Nonetheless, the three-month use of ginger improves serum insulin level, insulin resistance (HOMA-IR), and HDL-cholesterol level compared to baseline values. Further investigations with longer durations and larger sample sizes are recommended.

Exogenous ketone supplements have been suggested to have potential cardiovascular benefits, but their overall effect on blood pressure is unclear. Our objective was to perform a systematic review and meta-analysis on the effects of exogenous ketone supplements on blood pressure (BP) and concomitant changes in resting heart rate (HR). Five databases were searched on January 27^th, 2023, for randomized and non-randomized studies. A random-effects model meta-analysis was performed including all studies jointly and separately for acute and chronic ingestion of ketone supplements. Out of 4012 studies identified in the search, 4 acute and 6 chronic studies with n = 187 participants were included. Pooled results (n = 10) showed no change in systolic (SMD [95% CI]= -0.14 [-0.40; 0.11]; I²= 30%; p = 0.17) or diastolic BP (-0.12 [-0.30; 0.05]; I²= 0%; p = 0.69), with a potential tendency observed toward increased resting heart rate (0.17 [-0.14; 0.47]; I²= 40%; p = 0.10). Similar results for systolic and diastolic BP were observed when assessing separately the effect of acute and chronic ingestion of ketone supplements (p ≥ 0.33). Supplement dosage was found to modulate the increase in resting heart rate (0.019 ± 0.006; p = 0.013; R²=100%), suggesting that higher supplement doses lead to a higher resting heart rate. Based on currently available data, acute or prolonged ingestion of ketone supplements does not seem to modulate BP. However, a tendency for HR to increase after acute ingestion was observed, particularly with higher doses. Higher quality studies with appropriate standardized measurements are needed to confirm these results.