Placebo Beverage Research Articles

Koji amazake Maintains Water Content in the Left Cheek Skin of Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Comparative Trial.

PurposeImprovement in water content and skin barrier function on human skin is believed to be induced by koji amazake, a non-alcoholic beverage derived from rice fermented by Aspergillus oryzae (A. oryzae). In order to scientifically identify the effects of koji amazake on human skin, we performed a randomized, double-blind, placebo-controlled, parallel-group comparative trial and quantified the content of glucosylceramide (GlcCer) which would be responsible for the effects.Participants and MethodsHealthy adults concerned with their skin dryness were divided into koji amazake (N = 30) or placebo group (N = 30). During this test, the test beverages were ingested at 118 g/day. Their water content and trans-epidermal water loss (TEWL) were measured at 0 week (baseline) and 8 weeks. The content of GlcCer in test beverages was quantified by HPLC-ELSD.ResultsIn comparison with the placebo group, the water content in the left cheek of individuals in the koji amazake group was maintained for 8 weeks. In addition, changes in water content from the baseline to 8 weeks differed significantly between the koji amazake (0.19) and placebo groups (−3.98). Unexpectedly, there was no significant difference in the TEWL between koji amazake and placebo group. We analyzed GlcCer in both koji amazake and placebo beverages, which were found to contain 1.35 ± 0.11 and 0.30 ± 0.07 mg/118 g, respectively. The amount of GlcCer in koji amazake was approximately equal to the dosage of plant-derived GlcCer which has the ability to improve water content and TEWL in humans.ConclusionPresent study has shown that intake of koji amazake contributes to maintain the water content only on the left cheek. The content of GlcCer derived from koji amazake was adequate for maintenance of the water content compared to previous reports. Therefore, it was concluded that GlcCer in koji amazake acts as a functional ingredient.

Acute Effects of a Thermogenic Drink on Energy Expenditure

ObjectivesThermogenic energy drinks (TED) are consumed for a metabolic boost connected to weight loss. While there have been investigations on the thermogenic effects of TED, the exact ingredients and amount used in TED are brand and product-specific, and thus, the examination of the thermogenic effects of individual formulations is warranted. The objective of this study was to examine the acute thermogenic effects of a uniquely formulated zero-sugar TED containing caffeine, green coffee bean extract, amino acids and guarana, in healthy adults in a double-blind, randomized, cross-over study. MethodsHealthy adults (n = 30; 1:1 males: females; 18 to 50 years old; BMI 18 to 30 kg/m2) consumed a flavored carbonated placebo beverage (Control) and TED (355 ml each) on two separate occasions, separated by at least six days. Resting energy expenditure (REE) and respiratory exchange ratio (RER) were assessed before and at 1, 2, and 3 h after study product consumption. Secondarily, subjective ratings of hunger, desire to eat, and fullness as well as presence and intensity of gastrointestinal (GI) symptoms were assessed before and up to 3.25 h after study product consumption. ResultsCompared to Control, the consumption of TED resulted in significantly (P < 0.05) greater REE responses assessed over 3 h with peak REE observed at 1 h post consumption. This equated to an average of 150 kcal/d over 3 h. RER did not differ between study products. Subjective ratings of fullness were not statistically different between the TED and Control, but directionally indicated increased fullness and reduced desire to eat with the TED. Hunger ratings were lower at 3.25 h post-consumption of the TED compared to Control, suggesting that TED minimally affected appetitive sensations despite the increase in REE. The most common GI symptoms that were reported to develop at 3.25 h post-consumption of either study product were stomach rumbling, burping, and flatulence. There were no differences in the proportion of subjects that develop these GI symptoms between study products, suggesting that the TED was as well tolerated as the Control. ConclusionsThe findings suggest that the TED safely elicits thermogenic effects without affecting type of fuel oxidation or increasing appetite compared to control. Funding SourcesRowdy Energy.

The influence of a glucose administration on stress responsivity and memory after a socially evaluated cold pressor test

The nutritional state of participants prior to stress induction via a laboratory stressor has been demonstrated to influence reactivity of the Hypothalamus-Pituitary-Adrenal axis. So far, either primarily psychosocial or primarily physiological stressors have been utilized investigating this effect. In the present study, we aimed to fill this gap in the existing literature by utilizing a stressor that combines both elements, namely the Socially Evaluated Cold Pressor Test. Furthermore, we investigated how glucose consumption and subsequent stress induction influence long-term memory retrieval as well as working memory. In a 2 × 2 design, half of the 72 participants (36 women, 36 men) participated in the laboratory stressor while the other half participated in a control condition after having fasted for at least six hours. Thirty minutes prior to stress or control treatment, fasted participants consumed either 75 g of glucose or stevia-sweetened water. Salivary cortisol levels, systolic and diastolic blood pressure, as well as affect did not significantly differ between participants consuming glucose or the placebo beverage. Acute stress impaired working memory but had no effect on long-term memory retrieval. Glucose consumption did not significantly influence memory. Our results suggest that the intensity of a stressor might be important when determining the effects of a glucose administration on stress reactivity. The nutritional state of participants taking part in studies investigating the effects of acute stress on memory might be less decisive than previously assumed.

Effects of Regular Low-Level Alcohol Consumption in Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.

The effects of alcohol consumption on health are suggested to depend on the amount of alcohol consumed. We investigated the objective and subjective health effects of the daily consumption of a small amount of alcohol in healthy individuals using a randomized, double-blind, placebo-controlled crossover study. Accordingly, 15 male and 27 female Japanese adults with average or lower general well-being schedule (GWBS) scores were asked to consume a beverage with 0.5% (v/v) alcohol (~4 g of alcohol a day; test beverage) and a placebo beverage two times daily for 4 weeks each. Regular low-level alcohol consumption significantly decreased the serum liver function indexes (aspartic aminotransferase, alanine aminotransferase, and lactate dehydrogenase) before and after consumption (p = 0.034, 0.033, and 0.013, respectively). The small amount of alcohol did not affect the participants’ GWBS scores; however, a stratified analysis with poor subjective well-being revealed that these changes differed significantly between low-level alcohol consumption and placebo-treated subjects (16.0 vs. 11.5, p = 0.041). In addition, changes in serum testosterone levels demonstrated a higher trend in the group that received the test beverage compared with the group that received the placebo beverage (p = 0.051). Daily low-level alcohol consumption may have positive effects on liver function and subjective well-being.

Thrice daily consumption of a novel, premeal shot containing a low dose of whey protein increases time in euglycemia during 7 days of free-living in individuals with type 2 diabetes

IntroductionDuring acute feeding trials, consuming a large dose of whey protein (WP) before meals improves postprandial glucose regulation in people with type 2 diabetes. It is unclear if the reported...

Does acute alcohol consumption increase risk-taking while gambling? A systematic review and meta-analysis.

To estimate the effect of acute alcohol consumption on risk-taking while gambling, examine blood alcohol concentration as a moderator and explore possible moderators of this effect. A systematic review and meta-analysis was completed. A Boolean search strategy was used to identify studies that included (a) alcohol consumption as an independent variable; (b) a gambling or risk-taking task; (c) a control or placebo comparison; (d) human participants; and (e) English publications. Descriptive information, sample characteristics and experimental data were extracted from each study. Searched databases included: PsycINFO, Web of Science, Medline, Cochrane Library and ProQuest Dissertations and Theses. Included as participants were experiments that compared the effects of alcohol and non-alcoholic or placebo beverages on risk-taking while gambling. Comprehensive Meta-Analysis version 3.3.070 was used. Standardized mean differences of risk-taking while gambling between the experimental and control conditions were calculated when studies did not report effect sizes. Random-effects models were used for overall effect and meta-regressions while mixed-effects models were used for subgroup analyses. Twenty articles containing 47 alcohol versus control comparisons met inclusion criteria. The overall Hedges'g for the difference between groups consuming alcohol and groups consuming a placebo or non-alcoholic drink control was 0.03, 95% confidence interval (CI) = -0.07, 0.12, p = 0.60, indicating no significant difference. Larger effect sizes were found for studies using non-alcoholic control drinks (Hedges' g = 0.30, 95% CI = 0.01, 0.58) compared to placebo beverages (Hedges' g = -0.03, 95% CI = -0.13, 0.06), Cochran's Q= 4.67, p = 0.03. Finding that acute alcohol consumption had no reliable effect on risk-taking while gambling was consistent with existing animal research. No support was found for the relation between alcohol dose and risk-taking. The significantly larger effect size for experiments using non-alcoholic versus placebo beverages suggests the potential role of expectancy effects.

Novel Hydrolyzed Porcine and Fish Collagen Beverage Improved Collagen, Elasticity, Moisture, Spots: A Randomized, Double-blind, Placebo-controlled Trial

Background: As the population ages, oral hydrolyzed collagen supplements are gaining traction. However, few clinical studies on the skin health of hydrolyzed porcine collagen combined with fish collagen. Objective: This study investigates whether TripleUp collagen beverage has skincare and anti-inflammatory effects. Methods: Using collagen beverage to treat epidermal keratinocytes and examine ROS, HA, inflammatory factor, and moisturizing-related gene expressions (Tgm1, Krt14, FLG-F, GBA, HAS3). Fifty subjects were recruited into a placebo and collagen beverage group for four weeks and then examined skin condition at 0, 2, 4 weeks. Results: TripleUp collagen beverage decreased IL-8 and ROS expression and increased moisturizing-related gene expressions. In addition, collagen beverages increase skin collagen, elasticity, moisture, and decreased spots. Conclusions: Thus, TripleUp collagen beverage included hydrolyzed porcine, and fish collagen and vitamin C can improve skin condition.

Effects of acute arginine supplementation on neuroendocrine, metabolic, cardiovascular, and mood outcomes in younger men: A double-blind, placebo-controlled trial

ObjectivesArginine is an amino-acid supplement and precursor for nitric-oxide synthesis, which affects various biologic processes. The objective of this study was to determine the effects of arginine supplementation on growth hormone (GH) and metabolic parameters. MethodsThirty physically active, healthy men (age 18–39 y; body mass index: 18.5–25 kg/m2) were randomized in a double-blind, placebo-controlled, crossover trial. Arginine (10 g) and placebo (0 g) beverages were consumed after an overnight fast. Blood samples were collected at baseline and 1.5, 3.0, and 24 h after supplementation. The primary outcomes were serum GH and metabolomics. Also, amino acids, glucose, insulin, triacylglycerols, thyroid hormones, testosterone, cortisol, dehydroepiandrosterone, and mood state were assessed. Individuals with detectable increases in GH were analyzed separately (responders: n = 16; < 0.05 ng/mL at 1.5 h). Repeated-measure analyses of variance estimated the treatment effects at each timepoint. ResultsArginine levels increased at 1.5 h (146%) and 3.0 h (95%; P ≤ 0.001) and GH (193%) and thyroid-stimulating hormone (TSH; 10%) levels at 24 h (P < 0.05) after arginine versus placebo consumption. Arginine versus placebo increased glucose levels at 1.5 h (5%) and 3.0 h (3%; P ≤ 0.001). Arginine versus placebo did not affect other dependent measures, including mood state (P > 0.05), but changes in the urea, glutamate, and citric-acid pathways were observed. Among responders, arginine versus placebo increased GH at 1.5 h (37%), glucose at 1.5 h (4%) and 3.0 h (4%), and TSH at 24 h (9%; P < 0.05). Responders had higher levels of benzoate metabolites at baseline and 1.5 h, and an unknown compound (X-16124) at baseline, 1.5 h, and 24 h that corresponds to a class of gut microbes (P < 0.05). ConclusionsArginine supplementation modestly increased GH, glucose, and TSH levels in younger men. Responders had higher benzoate metabolites and an unknown analyte attributed to the gut microbiome. Future studies should examine whether the increased prevalence of these gut microorganisms corresponds with GH response after arginine supplementation.

Short-Term Intake of Chlorogenic Acids Improves Psychomotor Speed and Motor Speed in Adults: A Randomized Crossover Trial.

Chlorogenic acid (CGA), a polyphenolic compound found in various plants, has been reported to improve cognitive function. However, it remains unclear how long it takes for CGAs to exert their effects. Here, we evaluated the short-term effects of CGAs on cognitive function. We assessed the effects of 2-week CGA intake on cognitive function. The study was carried out as a randomized, double-blind, placebo-controlled, crossover trial. Twenty-six healthy Japanese participants (50–65 years of age) were randomly assigned to either the active beverage (CGAs: 270 mg) or the placebo beverage group daily for 2 weeks. After a 2-week washout period, the participants consumed the other beverages. We assessed cognitive function at baseline and following the first treatment period using the Japanese version of CNS Vital Signs. CGAs significantly improved the scores for psychomotor speed, motor speed, and right and left finger tapping compared to placebo. In addition, processing speed scores improved significantly from baseline only after CGA intake. In conclusion, CGAs were confirmed to improve cognitive function over a short period of two weeks.

Intake of Koji Amazake Improves Defecation Frequency in Healthy Adults.

Reportedly, the intake of koji amazake, a beverage made from steamed rice fermented by Aspergillus oryzae, improves defecation frequency. However, its functional ingredients and mechanism of action remain unclear. To compare the effects of koji amazake and a placebo beverage on defecation frequency and to identify the functional ingredients and mechanism of action, a randomized, placebo-controlled, double-blind parallel-group comparative trial was performed on two groups. The koji amazake had 302 ± 15.5 mg/118 g of A. oryzae cells, which was not in the placebo. Compared with the placebo group, the koji amazake group showed a significant increase in weekly defecation frequency at 2 weeks (5.09 days vs. 4.14 days), 3 weeks (5.41 days vs. 4.18 days), and 4 weeks (5.09 days vs. 3.95 days), along with an increase in the weekly fecal weight at 4 weeks (724 g vs. 501 g). The intake of koji amazake did not induce significant intergroup differences in the fecal SCFA concentration, whereas it significantly decreased the relative abundance of Blautia and significantly increased that of Bacteroides at 3 weeks. Therefore, koji amazake intake improved defecation frequency, and A. oryzae cells played potentially important roles as functional ingredients.

Effects of Heat-Killed Levilactobacillus brevis KB290 in Combination with β-Carotene on Influenza Virus Infection in Healthy Adults: A Randomized Controlled Trial

Influenza, a seasonal acute respiratory disease caused primarily by the influenza virus A or B, manifests with severe symptoms leading to considerable morbidity and mortality and is a major concern worldwide. Therefore, effective preventive measures against it are required. The aim of this trial was to evaluate the preventive effects of heat-killed Levilactobacillus brevis KB290 (KB290) in combination with β-carotene (βC) on influenza virus infections in healthy Japanese subjects aged between 20 and 59 y throughout the winter season. We performed a randomized, double-blind, placebo-controlled, parallel-group trial from 16 December 2019 to 8 March 2020, comparing KB290 + βC beverage with placebo beverage. The primary endpoint was the incidence of influenza based on a doctor’s certificate. The incidence of influenza was not significantly different between the two groups. However, the subgroup analysis showed a significant difference between the two groups (influenza incidence: the KB290 + βC group 1.9%, and the placebo group 3.9%) in the subgroup of subjects aged ˂40 y, but not in the subgroup of subjects aged ≥40 y. The results of this trial suggest that the combination of KB290 and βC might be a possible candidate supplement for protection against the seasonal influenza virus infection in humans aged <40 y, although further clinical studies are needed to confirm the concrete preventive effect of this combination on influenza.

Mixing Misery and Gin: The Effect of Alcohol Administration on Ostracism Response.

Williams's need-threat model proposes that ostracism responses are reflexive and, because of their evolutionary significance, difficult to diminish. Alcohol is widely consumed in social contexts and for reasons of coping with social stress, and major theories of alcohol propose that intoxication disrupts cognitive appraisal of environmental threats, leading to stress relief. Surprisingly, though, no well-powered experimental research has examined the impact of alcohol intoxication on distress from social ostracism. In three studies across two independent laboratories (N = 438), participants were randomly assigned to receive either an alcoholic or nonalcoholic (i.e., no-alcohol control or placebo) beverage and were exposed to an ostracism (or social inclusion) manipulation. Results, which emerged as remarkably consistent across all studies, indicated strong and consistent effects of ostracism on mood and needs satisfaction among both intoxicated and sober participants. Findings have important implications for ostracism theory and speak to boundary conditions for alcohol's ability to relieve stress.

Acute alcohol intoxication and the cocktail party problem: do \u201cmocktails\u201d help or hinder?

RationaleTo test the notion that alcohol impairs auditory attentional control by reducing the listener’s cognitive capacity.ObjectivesWe examined the effect of alcohol consumption and working memory span on dichotic speech shadowing and the cocktail party effect—the ability to focus on one of many simultaneous speakers yet still detect mention of one’s name amidst the background speech. Alcohol was expected either to increase name detection, by weakening the inhibition of irrelevant speech, or reduce name detection, by restricting auditory attention on to the primary input channel. Low-span participants were expected to show larger drug impairments than high-span counterparts.MethodsOn completion of the working memory span task, participants (n = 81) were randomly assigned to an alcohol or placebo beverage treatment. After alcohol absorption, they shadowed speech presented to one ear while ignoring the synchronised speech of a different speaker presented to the other. Each participant’s first name was covertly embedded in to-be-ignored speech.ResultsThe “cocktail party effect” was not affected by alcohol or working memory span, though low-span participants made more shadowing errors and recalled fewer words from the primary channel than high-span counterparts. Bayes factors support a null effect of alcohol on the cocktail party phenomenon, on shadowing errors and on memory for either shadowed or ignored speech.ConclusionFindings suggest that an alcoholic beverage producing a moderate level of intoxication (M BAC ≈ 0.08%) neither enhances nor impairs the cocktail party effect.

Does alcohol affect emotional face processing via interoceptive pathways?

BackgroundOur brain uses interoceptive signals from the body to shape how we perceive emotions in others; however, whether interoceptive signals can be manipulated to alter emotional perceptions is unknown. Alcohol has acute effects both on emotional processing and on the physiological substrates supporting interoception. In this registered report, we examine whether alcohol administration triggers physiological changes that alter interoceptive signals and manipulate emotional face processing. Such knowledge will broaden understanding of the mechanisms by which alcohol affects emotional face processing. MethodsParticipants (n = 36) will be administered an alcohol or placebo beverage. Cardiovascular physiology will be recorded before and after administration. Participants will complete two behavioral tasks in which they view emotional faces presented in synchrony with different phases of the cardiac cycle (i.e., systole, diastole). This manipulation creates an index of how interoceptive signals amplify emotional face processing. HypothesesWe hypothesize that, compared to placebo, alcohol administration will disrupt the cardiac amplification of emotional face processing. We further explore whether this disruption depends on the nature and magnitude of changes in cardiovascular physiology after alcohol administration.

Gravity-Induced Lower-Leg Swelling Can Be Ameliorated by Ingestion of α-Glucosyl Hesperidin Beverage.

The most likely cause of lower-leg swelling is prolonged sitting, which sometimes induces deep vein thrombosis, also known as, economy class syndrome. We aimed to clarify the influence of intake of 4G-α-glucopyranosyl hesperidin (G-Hsp) beverage on the lower-leg swelling caused by 6 h of sitting in six healthy women. All subjects ingested 100 mL of G-Hsp or Placebo beverages with 100 mL of mineral water after 10 min of rest in a chair. Subsequently, subjects were requested to sit in the chair in a relaxed position for 6 h with two breaks to walk for urination. Calf water content measured by impedance plethysmography, calf circumference, and calf skin temperature by infrared thermography were measured, along with assessment of calf swelling sensation on a visual analog scale. Increase in ankle % circumference was significantly less after the G-Hsp ingestion (101.8 ± 1.5%) than after placebo (103.3 ± 0.8%; P = 0.004). A significant difference was found between percent circumference after the G-Hsp and the placebo, that is, the calf swelling after the placebo was significantly larger (P = 0.043). A gradual increase in skin temperature at the lower limb was observed after G-Hsp ingestion, while there was no change after placebo. Gravity-induced calf and ankle swelling resulted by prolonged sitting can be ameliorated by oral ingestion of hesperidin-derived G-Hsp through production of nitric oxide. It might be helpful in preventing economy-class syndrome caused by enforced sitting for a long duration.

Prebiotic Effects of a Cranberry Beverage in a Randomized, Placebo-Controlled, Crossover Clinical Trial

ObjectivesThe objective was to evaluate the prebiotic effects of a milled whole cranberry beverage on modulating the gut microbiota in young adults. MethodsAdults (n = 17; ages 18–42 y; BMI 30.5 ± 3.1 kg/m2) were enrolled in a 60-d, two-period, randomized, placebo-controlled, crossover clinical study. Throughout the study, participants were fed a standardized 10-d cycle menu on site. During each 20-d treatment period, participants consumed twice daily a whole cranberry or placebo beverage (240 mL per serving). Treatment periods were separated by an 11-wk washout period and preceded by 10-d run-in periods on the controlled study diet. Fecal samples were collected before and after the dietary intervention for bacterial compositional analysis and short-chain fatty acid analysis by LC-MS/MS. The V5-V6 region of the 16S rRNA gene in fecal DNA was amplified and sequenced. Taxonomy was assigned using the q2-feature-classifier in QIIME2 and matched against the Greengenes 13_8 database. Differential abundance was analyzed using ANCOM2 in R. Alpha-diversity was assessed using Faith’s PD, Shannon diversity, and observed OTU richness generated by QIIME 2 and compared between treatments using Mann-Whitney U test. Beta-diversity was compared between treatments using PERMANOVA of the weighted and unweighted UniFrac distances between samples generated by QIIME 2. ResultsCoriobacteriaceae was significantly more abundant after participants consumed the cranberry as compared with the placebo beverage (ANCOM W > 0.7). The clinically-important pathogen Clostridium perfringens was present after consumption of the placebo beverage, but was a structural zero (not present) after consumption of the cranberry beverage. Alpha-diversity, beta-diversity, and fecal short-chain fatty acid concentrations did not differ between treatments. ConclusionsDaily consumption of a whole cranberry beverage resulted in favorable change in the composition of the gut microbiota and thus showed prebiotic potential. Funding SourcesOcean Spray Cranberries, Inc.

An Exogenous Ketone Ester Modulates Appetite but Not Dietary Intake

ObjectivesPrevious research suggests exogenous ketone esters (KE) suppress appetite by directly modulating regulatory hormones; however, their impact upon eating behaviors is unknown. The authors aimed to determine if the diminished appetite resulting from KE consumption is accompanied by a reduction in dietary intake. MethodsAfter informed consent participants (n = 7) were recruited to a randomized cross-over trial. Participants recorded their diet for three consecutive days, starting the day prior to their first study appointment. During this visit, fasted participants were randomized to consume either a KE or matched dextrose placebo (DP) beverage. Blood samples were drawn at regular intervals and analyzed for β-hydroxybutyrate (BHB), glucose, leptin and ghrelin. Appetite was self-reported using a visual analogue scale (VAS). One-week later participants were invited to a second visit where the study was repeated using the other beverage. Dietary data was analyzed using MyFood24 and statistical analysis was performed using Microsoft Excel and IBM SPSS (v.26). ResultsBHB increased 30 minutes after consuming the KE (0.21 ± 0.20 to 4.21 ± 0.66 mmol/L) (P < 0.001) and remained elevated. Blood glucose increased 30 minutes after consuming the DP (4.87 ± 0.42 to 8.11 ± 1.41 mmol/L) (P < 0.001) and promptly returned to baseline. Although there were no changes in leptin levels, those who consumed the KE demonstrated suppressed ghrelin production 120 minutes after baseline (2430.00 ± 323.46 to 1763.14 ± 367.67 pg/mL) (P = 0.026). Furthermore, the VAS also revealed that 120 minutes after baseline participants who consumed the DP reported a greater desire to eat (+26.86 ± 23.55 mm) (P = 0.038) and were less satisfied (–30.43 ± 12.52 mm) (P = 0.003). Despite this, there was no significant differences in the calorie intake of those who consumed the KE compared to the DP on the day before (1941.06 ± 1048.13 vs 1792.86 ± 833.23 kcal), during (1594.64 ± 677.07 vs 1536.52 ± 457.22 kcal) or after (1674.41 ± 801.43 vs 1914.35 ± 804.78 kcal) the study visits. ConclusionsConsuming a KE, despite impacting upon self-reported measures of appetite and associated biomarkers, does not modulate dietary intake. This should be considered when assessing the potential role of KE for appetite management. Funding SourcesLiverpool Hope University.

Abstract P134: Preliminary Data: Dietary Nitrate Supplementation Does Not Extend Dry Static Apnea Or Wingate Performance

Introduction: Previous studies have examined dietary nitrate supplementation and its effects on dry static apnea, and peak power. Dietary nitrate supplementation has been found to increase maximal apnea and peak power output. The purpose of this study was to determine the effects of beetroot juice on dry static apnea and Wingate performance. Hypothesis: Dietary nitrate will improve maximal breath hold time and peak power output. Dietary nitrate will improve tolerance to CO2, thereby improving maximal breath hold time and anaerobic capacity. Methods: In a randomized, double-blind, counterbalanced study, five healthy males (20.4±0.89 years) visited the lab on 3 separate occasions each separated by one week. Visit 1 served as a Wingate and breath hold familiarization visit. Prior to visits 2 and 3 participants were instructed to drink a beverage either a placebo (negligible nitrate content, PL) or dietary nitrate rich beverage (12.4 mmol nitrate, NIT) during the 4 days leading up to their next visit. Visits 2 and 3 consisted of two submaximal breath holds (80% of maximal determined during visit 1), with 2 minutes of rest between and three minutes of rest preceding the final breath hold for maximal duration. Finally, participants completed a standardized 10-minute warmup on the cycle ergometer before completing a 30-second maximal effort Wingate test. Results: A linear mixed effects model was used to determine whether treatment (NIT vs. PL) was associated with differences in VCO2 or PetCO2. Time (0, 10, 20, 30 min post-breath hold) and Treatment both served as repeated measures. Models were developed using multiple repeated measures covariance matrix structures, and the model with the lowest AIC was chosen as the final model. The interaction between time and treatment was included in the original models, and was removed if it was not statistically significant. Time was a statistically significant factor for VCO2 and PetCO2 (p &lt; 0.001). Treatment, and the Time x Treatment interaction was not significant for either variable. No differences between NIT and PL were observed during the Wingate test for either time to peak power (5.02±2.45 and 6.2±2.43 sec, respectively) or maximal power (9.73±1.01 and 9.72±1.03 watts/kg, respectively) and fatigue index (49.42±14.98 and 47.30±6.99 watts/sec, respectively). Conclusion: Preliminary data indicates that in a general population four days of dietary nitrate supplementation may not improve breath hold time, tolerance to carbon dioxide in the lungs, or Wingate performance.

A randomized trial of safety and pharmacodynamic interactions between a selective glucocorticoid receptor antagonist, PT150, and ethanol in healthy volunteers

PT150, a novel competitive glucocorticoid receptor (GR) antagonist, has proven safe in animal models, healthy volunteers, and people with depression. Our study is the first to investigate PT150’s safety with alcohol use. The primary objective of this study was to evaluate pharmacodynamic interactions between ethanol and PT150 in healthy subjects. This single-site, Phase I pilot trial consisted of community-recruited, healthy, alcohol-experienced participants aged 21–64 years. Of 32 participants screened, 11 were enrolled and randomized, one of which withdrew before intervention. PT150 (900 mg/day) was administered orally to all participants for five days. All participants received two beverage challenges on Day 1 (before PT150 administration) and Day 5 (after PT150 administration). On challenge days, they received both alcohol (16% ethanol) and placebo (1% ethanol) beverages in random order. Primary outcomes included breath alcohol level, blood pressure, heart rate, adverse events, and electrocardiogram changes. There were no statistically significant differences in vital signs or estimated blood alcohol concentrations between PT150 non-exposed and exposed groups during the ethanol challenge. There were no clinically significant abnormal electrocardiograms or serious adverse events. These data show that administration of PT150 with concurrent alcohol use is safe and well-tolerated. This study supports a future pharmacokinetic interaction study between PT150 and alcohol.Trial Registration ClinicalTrials.gov Identifier: NCT03548714.

Impact of cranberry juice consumption on gut and vaginal microbiota in postmenopausal women

AbstractCranberries have long been purported to provide protection against urinary tract infections. There is a line of evidence suggesting that causal pathogens might be seeded from the bacteria reservoirs in the intestinal and vaginal tracts. We tested the hypothesis whether cranberry intake would reshape bacteria taxa in the gut, as well as the vaginal ecosystem. A total of 25 postmenopausal women were enrolled into a randomized, double‐blind, placebo‐controlled study. Stool samples and vaginal swabs were collected at baseline and after 15 days of consumption of placebo or cranberry beverages, microbiota analyses were performed by Illumina Miseq sequencing following a double‐index 16S rRNA gene amplicon. All baseline stool samples generally fell in theBacteroidesenterotype. Significant increases ofPrevotella(P = 0.04),ClostridiumXIVa members (P = 0.04),Eggerthella(P = 0.03), andBifidobacterium(P = 0.02) were shown following the cranberry juice intervention; this indicates modulation of the gut microbiota by cranberry components. Baseline vaginal microbiotas fell in three distinct patterns—Lactobacillusdominant, diversified microbiome, andStreptococcusdysbiosis. Compared with the placebo, the cranberry intervention significantly reduced the abundance of pathogenicStreptococcus(P = 0.04) in the dysbiosis group and increased commensal bacteriaAnaerococcus,Finegoldia,Actinomyces, andCorynebacteriumin the diversified microbiome and dysbiosis groups. Overall, these data suggest that cranberry consumption may improve vaginal microbiota composition in individuals with dysbiosis. Gut‐borne taxa stimulation by the combination of cranberry oligosaccharides and polyphenols present in the cranberry product potentially mediates these beneficial properties.