Placebo Beverage Research Articles

A Multiomics Evaluation of the Countermeasure Influence of 4-Week Cranberry Beverage Supplementation on Exercise-Induced Changes in Innate Immunity.

This study examined the effect of a 4-week unsweetened cranberry beverage (CRAN) (317 mg polyphenols) versus placebo beverage (PLAC) ingestion (240 mL/day) on moderating exercise-induced changes in innate immunity. Participants included 25 male and female non-elite cyclists. A randomized, placebo-controlled, double-blind crossover design was used with two 4-week supplementation periods and a 2-week washout period. Supplementation periods were followed by an intensive 2.25 h cycling bout. Six blood samples were collected before and after supplementation (in an overnight fasted state) and at 0 h, 1.5 h, 3 h, and 24 h post-exercise. Stool and urine samples were collected pre- and post-supplementation. Outcome measures included serum creatine kinase, myoglobin, and cortisol, complete blood counts, plasma untargeted proteomics, plasma-targeted oxylipins, untargeted urine metabolomics, and stool microbiome composition via whole genome shotgun (WGS) sequencing. Urine CRAN-linked metabolites increased significantly after supplementation, but no trial differences in alpha or beta microbiota diversity were found in the stool samples. The 2.25 h cycling bout caused significant increases in plasma arachidonic acid (ARA) and 53 oxylipins (FDR q-value < 0.05). The patterns of increase for ARA, four oxylipins generated from ARA-cytochrome P-450 (CYP) (5,6-, 8,9-, 11,12-, and 14,15-diHETrEs), two oxylipins from linoleic acid (LA) and CYP (9,10-DiHOME, 12,13-DiHOME), and two oxylipins generated from LA and lipoxygenase (LOX) (9-HODE, 13-HODE) were slightly but significantly higher for the CRAN versus PLAC trial (all interaction effects, p < 0.05). The untargeted proteomics analysis showed that two protein clusters differed significantly between the CRAN and PLAC trials, with CRAN-related elevations in proteins related to innate immune activation and reduced levels of proteins related to the regulation of the complement cascade, platelet activation, and binding and uptake of ligands by scavenger receptors. No trial differences were found for cortisol and muscle damage biomarkers. CRAN versus PLAC juice resulted in a significant increase in CRAN-related metabolites but no differences in the gut microbiome. CRAN supplementation was associated with a transient and modest but significant post-exercise elevation in selected oxylipins and proteins associated with the innate immune system.

The effect of a pre-meal snack and/or postprandial exercise on breakfast glycemic excursion in adults with cystic fibrosis: A pilot study

Background & AimsCystic fibrosis (CF)-related diabetes (CFRD), a common comorbidity in CF, is often preceded and characterized with elevated postprandial glycaemia (PPG). In the general population, the consumption of a pre-meal protein snack and/or physical activity (PA) hinder the elevation of PPG levels. Our objective is to evaluate the effect of a pre-meal snack and/or post-meal PA on PPG excursions in CF. MethodsThis is a double-blinded randomized controlled crossover interventional study in 14 adults with CF, with 4 interventions: placebo pre-meal snack + no PA (control: CTL), pre-meal soy snack + no PA (SK), placebo pre-meal snack + PA (PA), and pre-meal soy snack + PA (SK+PA). The pre-meal soy snack or placebo beverage (vanilla flavoured water) is served at 8 am, followed by a standardized breakfast at 9 am and, postprandially, 5 repeated bouts of 3-min walk every 30 mins or sedentary activity. Blood glucose and insulin were measured every 15 to 30 minutes during the interventions. ResultsPlasma glucose (PG) was higher 30 mins after snack consumption compared to placebo beverage. One-hour post-breakfast, PG levels were lower during both PA interventions than with sedentary behavior. However, the overall 3h post-breakfast glucose area under the curve (AUC) was similar between interventions. Post-breakfast 3h insulin AUC was significantly lower during the SK+PA intervention compared to the sedentary behavior interventions. ConclusionRepeated short bouts of post-meal physical activity may positively impact PPG control in adults with CF, with or without the addition of a pre-meal soy snack. A pre-meal snack alone does not improve PPG.

Determinants of perceived pain relief from acute alcohol intake in a laboratory setting

BackgroundStudies of alcohol analgesia often assume that changes in pain sensitivity reflect the negative reinforcing effects of alcohol in pain self-management. However, factors that may influence perceived pain relief due to alcohol use remain incompletely characterized. Thus, the primary aim of this study was to identify which factors are most strongly related to self-reported pain relief in individuals with and without chronic pain after alcohol consumption. MethodsThis study combined data from two studies of alcohol analgesia in individuals who regularly consume alcohol with and without chronic pain. Alcohol analgesia expectancies were assessed during screening. In laboratory sessions, participants received an alcohol-containing (.08g/dL target BrAC) or placebo beverage and rated subjective intoxication and subjective response (positive/negative aspects of stimulation/sedation). Participants underwent quantitative sensory testing to measure pain intensity, pain threshold, and relief. Paired sample t-tests determined effects of alcohol on pain measures. Hierarchical linear models determined factors associated with pain relief ratings in the alcohol condition. ResultsPain relief and pain threshold were higher in the alcohol session relative to placebo, but pain intensity did not differ. In a 4-step hierarchical linear model, expectancy of pain relief, subjective intoxication, and high positive affect, but not pain threshold or pain intensity, were significantly and uniquely associated with perceived relief. ConclusionsTaken together, results suggest the negative-reinforcing effects of alcohol for pain-management are not completely reflected by changes in pain sensitivity in a laboratory setting. Expectancies and subjective response may be important in determining an individual’s evaluation of alcohol’s efficacy for pain self-management.

Evaluating the Effect of Lacticaseibacillus paracasei Strain Shirota on the Physical Consistency of Stool in Healthy Participants with Hard or Lumpy Stools: A Double-Blind, Randomized, Placebo-Controlled Study.

We have earlier established a direct measurement method for assessing stool physical consistency using a texture analyzer (TAXT). The present study aimed to evaluate the stool softening effect of Lacticaseibacillus paracasei strain Shirota (LcS) using TAXT in a double-blind, randomized, placebo-controlled study. Sixty-four healthy participants with a Bristol stool form scale (BSFS) 1/2 ≥ 50% during screening consumed fermented milk containing LcS or a placebo beverage daily for 8 weeks. Stool consistency and water content were determined using TAXT and a lyophilizer, respectively. Participants evaluated their defecation using the BSFS. Stool consistency evaluated by a texture analyzer (TAXT) in the LcS group tended to be softer than that in the placebo group (p = 0.052). Subgroup analyses (TAXT value at baseline ≥ 4.5) showed that stool consistency was significantly softer in the LcS group (p = 0.014). Stool water content was also significantly higher in the LcS group than in the placebo group, but the proportion of normal stools was not statistically significant. We were unable to find evidence for the softening effect of LcS under the present study's conditions. However, its efficacy may be confirmed by targeting participants with physically hard stools and TAXT values ≥ 4.5.

Effects of Heat-Treated Lactobacillus helveticus CP790-Fermented Milk on Gastrointestinal Health in Healthy Adults: A Randomized Double-Blind Placebo-Controlled Trial.

Probiotic-fermented milk is commonly used to maintain intestinal health. However, the effects of heat-treated fermented milk, which does not contain live microorganisms, on intestinal function are not yet fully understood. This study aimed to investigate whether heat-treated Lactobacillus helveticus CP790-fermented milk affects fecal microbiota and gut health as a "postbiotic". A randomized, double-blind, placebo-controlled trial was conducted in healthy Japanese individuals aged 20-59 years with a tendency toward constipation. Participants consumed 100 mL of either the test beverage (n = 60) or placebo beverage (n = 60) for four weeks. The test beverages were prepared with heat-treated CP790-fermented milk, while the placebo beverages were prepared with nonfermented milk flavored with lactic acid. Fecal samples were analyzed using 16S rRNA gene sequencing. Constipation symptoms were assessed using defecation logs and the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. Mood state was also assessed using the Profile of Mood States 2 (POMS2) questionnaire to explore its potential as a "psychobiotic". Desulfobacterota were significantly decreased by CP790-fermented milk intake. PICRUSt2 analysis predicted a decrease in the proportion of genes involved in the sulfate reduction pathway following the consumption of CP790-fermented milk. The CP790-fermented milk intervention significantly improved stool consistency and straining during defecation. These improvements were correlated with a decrease in Desulfobacterota. After the intervention, overall mood, expressed as total mood disturbance, and depression-dejection were significantly better in the CP790 group than in the placebo group. These results suggest that the intake of CP790-fermented milk could be effective in modulating gut microbiota and improving constipation symptoms and mood states.

Response to lowering plasma glucose is characterised by decreased oxyntomodulin: Results from a randomised controlled trial

BackgroundWith the prevalence of diabetes reaching an epidemic level, there is a growing interest in the investigation of its remission. Proglucagon-derived peptides (PGDP) have been shown to have a glucose-regulating effect. However, whether they play a role in diabetes remission remains poorly understood. AimTo investigate changes in plasma levels of PGDP in glycaemic responders versus non-responders. MethodsThe study was a randomised placebo-controlled trial comprising 18 adults with prediabetes (registered at www.ClinicalTrials.gov as NCT03889210). Following an overnight fast, participants consumed ketone β-hydroxybutyrate (KEβHB)-supplemented beverage and placebo beverage in crossover manner. Serial blood samples were collected from baseline to 150 min at 30-min intervals. The endpoints were changes in glucagon-like peptide-1 (GLP-1), glicentin, oxyntomodulin, glucagon, and major proglucagon fragment (MPGF). Participants were stratified into the 'responders' and ‘non-responders' subgroups based on their glycaemic changes following the ingestion of KEβHB. The area under the curve (AUC) was calculated to estimate the accumulated changes in the studied PGDP and compared using paired-t test between the KEβHB and placebo beverages. ResultsResponders had a significantly greater reduction in plasma glucose compared with non-responders following acute ketosis (p < 0.001). The AUC0-150 for oxyntomodulin was significantly lower following the KEβHB beverage compared with the placebo (p = 0.045) in responders, but not in non-responders (p = 0.512). No significant differences in AUCs0-150 were found for GLP-1, glicentin, glucagon, and MPGF in either responders or non-responders. ConclusionOxyntomodulin is involved in lowering plasma glucose and may play an important role in diabetes remission.

The impact of alcohol consumption on implicit racial bias.

Researchers and theorists studying intergroup relations have been interested in the impact of alcohol on interracial responding. Theories predict that alcohol will exacerbate expressions of racial bias by increasing reliance on stereotypes and/or by decreasing controlled processing and self-monitoring. Prior studies testing these theories have often examined alcohol's effects on implicit (i.e., indirect) measures of racial bias with inconsistent results. However, previous research in this area has suffered from several methodological limitations, including small sample sizes and doses of alcohol that may have been too low to induce substantial intoxication. Here, in more than triple the number of alcohol participants than the largest prior study, we tested whether an intoxicating dose of alcohol (target breath alcohol concentration of .08%) exacerbated implicit racial bias. Young adults who identified as races other than Black or African American (N = 207) were randomly assigned to consume an alcoholic or placebo beverage and completed the race-based Implicit Association Test (race IAT) testing implicit preference for White (vs. Black) individuals [or, conversely, bias against Black (vs. White) individuals]. All participants demonstrated an implicit racial bias (i.e., linking traditionally Black names with negative/unpleasant words), with no difference in this implicit racial bias across beverage conditions. Specifically, there were no differences between alcohol participants' race IAT D scores (M = 0.55, SD = 0.39), and placebo participants' race IAT D scores (M = 0.59, SD = 0.35), b = 0.05, 95%CI [-0.07, 0.18], p = .422. These findings challenge theories and prior studies suggesting that alcohol increases implicit racial bias. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young men

BackgroundSexual violence (SV) is a significant, global public health problem, particularly among young adults. Promising interventions exist, including prosocial bystander intervention programs that train bystanders to intervene in situations at-risk for SV. However, these programs suffer from critical weaknesses: (1) they do not address the proximal effect of alcohol use on bystander decision-making and (2) they rely on self-report measures to evaluate outcomes. To overcome these limitations, we integrate new content specific to alcohol use within the context of prosocial bystander intervention into an existing, evidence-based program, RealConsent1.0. The resulting program, RealConsent2.0, aims to facilitate bystander behavior among sober and intoxicated bystanders and uses a virtual reality (VR) environment to assess bystander behavior in the context of acute alcohol use.MethodsThis protocol paper presents the design of a randomized controlled trial (RCT) in which we evaluate RealConsent2.0 for efficacy in increasing alcohol- and non-alcohol-involved bystander behavior compared to RealConsent1.0 or to an attention-control program (“Taking Charge”). The RCT is being implemented in Atlanta, GA, and Lincoln, NE. Participants will be 605, healthy men aged 21–25 years recruited through social media, community-based flyers, and university email lists. Eligible participants who provide informed consent and complete the baseline survey, which includes self-reported bystander behavior, are then randomized to one of six conditions: RealConsent2.0/alcohol, RealConsent2.0/placebo, RealConsent1.0/alcohol, RealConsent1.0/placebo, Taking Charge/alcohol, or Taking Charge/placebo. After completing their assigned program, participants complete a laboratory session in which they consume an alcohol (target BrAC: .08%) or placebo beverage and then engage in the Bystanders in Sexual Assault Virtual Environments (BSAVE), a virtual house party comprising situations in which participants have opportunities to intervene. Self-reported bystander behavior across alcohol and non-alcohol contexts is also assessed at 6- and 12-months post-intervention. Secondary outcomes include attitudes toward, outcome expectancies for, and self-efficacy for bystander behavior via self-report.DiscussionRealConsent2.0 is the first web-based intervention for young men that encourages and teaches skills to engage in prosocial bystander behavior to prevent SV while intoxicated. This is also the first study to assess the proximal effect of alcohol on bystander behavior via a VR environment.Trial registrationClinicaltrials.gov, NCT04912492. Registered on 05 February 2021

Acute electrophysiological effects of energy drink, energy gum and coffee: a double-blind randomized placebo-controlled crossover study

Abstract Background Energy drink consumption is highly prevalent in young adults, especially in males, and has been associated with adverse cardiovascular events, including QT prolongation and atherothrombosis. A proposed mechanism underlying these adverse cardiovascular effects is caffeine, but this has not been systematically evaluated. Therefore, the purpose of this study was to compare the acute electrophysiological effects of energy drink consumption with other forms of caffeine consumption in young males. Methods We performed a randomized, double-blind, placebo-controlled, crossover study in 16 young healthy males. Each participant underwent electrocardiography assessment at pre- and post-treatment (1-hour and 2-hours) in response to 4 beverage and gum combinations: 1) energy drink + placebo gum (ED); 2) coffee + placebo gum (C); 3) placebo beverage + caffeinated energy gum (EG); and 4) placebo beverage + placebo gum (P). Caffeine content was the same in all treatment combinations and a washout period of at least 1-week was allowed among treatments. Results At 1-hour post-treatment, heart rate increased in response to ED while it decreased in response to EG (p&amp;lt;0.05 for ED vs. EG; Figure 1A). At 2-hours post-treatment, the increase in heart rate after ED and Coffee was significantly greater compared to the change in heart rate in response to the other treatments (p&amp;lt;0.05). The increase in QRS duration 1-hour post-treatment was significantly greater after ED compared to EG and Placebo (p &amp;lt;0.05). Corrected QT (QTc) duration was significantly reduced at 1-hour post-treatment in response to EG vs. ED (p&amp;lt;0.05), but was not different compared to the other treatments. At 2-hours post-treatment, QTc duration was significantly reduced in response to EG and was increased in response to Coffee (p &amp;lt; 0.05 for EG vs. ED and C, Figure 1C). The most prominent increase from baseline in the percentage of participants experiencing ventricular ectopy was in response to ED (Figure 1D). Conclusions The acute electrophysiological effects of energy drink, energy gum and coffee do not appear to be mediated by caffeine content. Further investigations are warranted to better understand the cardiovascular effects of these caffeinated products.

The chronic alcohol consumption influences the gonadal axis in men: Results from a meta-analysis.

Low testosterone concentrations affect 2-13% of adult males, with a direct association between reduction in testosterone (T) concentrations and cardiovascular events. Lifestyle habits have been linked to visceral fat accumulation and endocrine disorders like secondary hypogonadism. Alcohol intake has also been a topic of debate, with studies showing a detrimental effect on sperm production and underlying mechanisms. This meta-analysis aims to comprehensively evaluate the effect of alcohol consumption on T serum concentrations in adult men. The literature search included only controlled clinical trials comparing men who drink alcohol to men who do not, or who assumed placebo or nonalcoholic beverages. The primary outcome was the comparison of total testosterone serum concentrations between the study and control groups. The publications were examined for publication bias using Egger's test. Twenty-one studies were included in the analysis for a total of 30 trials that examined the effects of alcohol consumption on testosterone level in 10,199 subjects. The meta-analysis showed that alcohol consumption overall is related to significant reduction in circulating concentrations of total testosterone (mean difference [MD]=-4.02; 95% CI -6.30, -1.73), free T (MD=-0.17; 95% CI -0.23, -0.12), sex hormone binding globulin (SHBG) (MD=-1.94; 95% CI -3.37, -0.48), an increase in estradiol (E2) (MD=7.65; 95% CI 1.06, 14.23) and neutral effect on luteinizing hormone (LH) (MD=-0.15; 95% CI -0.36, 0.06), independently by age, body mass index (BMI), E2, and LH serum concentrations and alcohol intake. However, these results are evident only in healthy men exposed to chronic alcohol consumption and not in those with a recognized diagnosis of alcohol use disorder or after acute alcohol intake. This study suggests how chronic alcohol consumption may inhibit the gonadal axis in healthy men, although the exact pathophysiological mechanisms connecting alcohol exposure and steroidogenesis are still not completely clarified.

Impact of a specialized oral nutritional supplement on quality of life in older adults following hospitalization: Post-hoc analysis of the NOURISH trial

Both during and after hospitalization, nutritional care with daily intake of oral nutritional supplements (ONS) improves health outcomes and decreases risk of mortality in malnourished older adults. In a post-hoc analysis of data from hospitalized older adults with malnutrition risk, we sought to determine whether consuming a specialized ONS (S-ONS) containing high protein and beta-hydroxy-beta-methylbutyrate (HMB) can also improve Quality of Life (QoL). We analyzed data from the NOURISH trial-a randomized, placebo-controlled, multi-center, double-blind study conducted in patients with congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease. Patients received standard care+S-ONS or placebo beverage (target 2 servings/day) during hospitalization and for 90 days post-discharge. SF-36 and EQ-5D QoL outcomes were assessed at 0-, 30-, 60-, and 90-days post-discharge. To account for the missing QoL observations (27.7%) due to patient dropout, we used multiple imputation. Data represent differences between least squares mean (LSM) values with 95% Confidence Intervals for groups receiving S-ONS or placebo treatments. The study population consisted of 622 patients of mean age ±standard deviation: 77.9±8.4 years and of whom 52.1% were females. Patients consuming placebo had lower (worse) QoL domain scores than did those consuming S-ONS. Specifically for the SF-36 health domain scores, group differences (placebo vs S-ONS) in LSM were significant for the mental component summary at day 90 (-4.23 [-7.75,-0.71]; p=0.019), the domains of mental health at days 60 (-3.76 [-7.40,-0.12]; p=0.043) and 90 (-4.88 [-8.41,-1.34]; p=0.007), vitality at day 90 (-3.33 [-6.65,-0.01]; p=0.049) and social functioning at day 90 (-4.02 [-7.48,-0.55]; p=0.023). Compared to placebo, differences in LSM values for the SF-36 general health domain were significant with improvement in the S-ONS group at hospital discharge and beyond: day 0 (-2.72 [-5.33,-0.11]; p=0.041), day 30 (-3.08 [-6.09,-0.08]; p=0.044), day 60 (-3.95 [-7.13,-0.76]; p=0.015), and day 90 (-4.56 [-7.74,-1.38]; p=0.005). In hospitalized older adults with cardiopulmonary diseases and evidence of poor nutritional status, daily intake of S-ONS compared to placebo improved post-discharge QoL scores for mental health/cognition, vitality, social functioning, and general health. These QoL benefits complement survival benefits found in the original NOURISH trial analysis. NCT01626742.

Matcha green tea beverage moderates fatigue and supports resistance training-induced adaptation

BackgroundResistance training adaptively increases muscle strength and mass, contributing to athletic performance and health promotion. Dietary intervention with natural foods provides nutrients that help accelerate muscle adaptation to training. Matcha green tea contains several bioactive factors such as antioxidants, amino acids, and dietary fibers; however, its effect on muscle adaptation is unclear. In this study, we aimed to investigate the effects of matcha beverage intake on muscle adaptation to resistance training.MethodsHealthy, untrained men were randomized into placebo and matcha groups. Participants consumed either a matcha beverage containing 1.5 g of matcha green tea powder or a placebo beverage twice a day and engaged in resistance training programs for 8 (trial 1) or 12 weeks (trial 2).ResultsIn trial 1, maximum leg strength after training tended to increase more in the matcha group than that in the placebo group. In the matcha group, subjective fatigue after exercise at 1 week of training was lower than that in the placebo group. Gut microbe analysis showed that the abundance of five genera changed after matcha intake. The change in Ruminococcus, Butyricimonas, and Oscillospira compositions positively correlated with the change in maximum strength. In trial 2, the change in skeletal muscle mass in response to training was larger in the matcha group. In addition, the salivary cortisol level was lower in the matcha group than that in the placebo group.ConclusionDaily intake of matcha green tea beverages may help in muscle adaptation to training, with modulations in stress and fatigue responses and microbiota composition.

The effects of depressed mood and 0.05 % blood alcohol concentration on risky driving in males

Males are more likely than females to use alcohol as a maladaptive coping mechanism to alleviate symptoms of depressed mood. The effects of a combination of subclinical depressed mood and doses of alcohol below the per se legal threshold of 0.08 % blood alcohol concentration (BAC) on risky driving are unclear, however. This manuscript presents a quasi-experimental, between-subjects study testing the influence of combined subclinical depressed mood and 0.05 % BAC on risky driving in a simulator and the mediation of decision-making. Following assessment of depressed mood (Beck Depression Inventory-II), a double-blinded protocol was used to randomise participants and administer either an alcohol (0.05 % BAC) or a placebo (0.00 % BAC) beverage. The Iowa Gambling Task tested decision-making and participants indicated whether they would decide to drive in the simulator. Driving simulation measured risky driving in real-time. Participants were healthy male drivers (n = 57; age M = 38.2, SD = 7.5). Using ANOVA, there were non-significant group differences in risky driving. Logistic regression revealed non-significant effects between groups in predicting the decision to drive. Mediation regression was used to explore the underlying mechanisms of decision-making on the prediction of risky driving under depressed mood. However, decision-making under risk was only identified as a significant predictor of mean merge acceleration on the highway. In addition to the limited sample size, outcomes were likely impacted by the mediation of emotion regulation. As this research area remains promising, recommendations are highlighted. One of them includes the use of a measure of depressed mood that is more sensitive to externalising behavioural symptoms in males.

617-P: Time in Range following Mealtime Protein Supplementation Is Predicted by Liver Health and ß-Cell Function in Adults with Type 2 Diabetes

Background: Consuming mealtime whey protein supplementation increases daily time in euglycemic range [TIR] in adults with type 2 diabetes [T2D] with inter-individual responses. The present post-hoc analysis aimed to identify metabolic predictors to the effectiveness of pre-meal whey protein. Methods: In a randomized-crossover design, 16 individuals with T2D [HbA1c 57±9 mmol/mol) underwent two 7d free-living periods where they consumed a whey protein (15g) or placebo beverage before each main meal. Glucose control was captured by blinded continuous glucose monitoring. Patient anthropometric and fasting markers of liver health and glucose metabolism were obtained at baseline. β-cell function was determined by the ratio of the incremental changes in insulin secretion to glucose during a feeding test. The relationship between TIR and clinical markers were analyzed by correlational analysis, and predictors of TIR were determined by multiple regression. Results: β-cell function was a strong determinant to TIR during both the whey (rs=0.615; p=0.011) and placebo (rs=0.598; p=0.019) weeks. Around 76% of the variance in TIR during the whey week was accounted by β-cell function, and fasting insulin and alanine aminotransferase concentrations (adj R2=0.760; p&amp;lt;0.001). During the whey intervention, TIR was inversely associated with aspartate aminotransferase (rs=−0.506; p=0.046) and tended to be related to fasting glucagon (rs=−0.482; p=0.058), whereas there were no associations between liver health or fasting hormonal markers with TIR during placebo (p&amp;gt;0.05). Conclusions: In a small cohort of people with T2D, our data indicates that those with compromised liver health and reduced β-cell function may experience a reduction in TIR when consuming mealtime protein supplementation. This is possibly due to disruptions in the liver-α-cell axis, which may be further aggravated by increasing plasma amino acid availability from protein supplementation. Disclosure K.Smith: None. G.Taylor: None. M.Walker: None. K.A.Bowden davies: None. E.J.Stevenson: None. D.J.West: None. Funding Francis James Bell Endowment Fund; County Durham Community Foundation

A Double-Blind, Randomized, Placebo-Controlled Pilot Study examining an Oxygen Nanobubble Beverage for 16.1-km Time Trial and Repeated Sprint Cycling Performance

There is growing interest of ergogenic aids that deliver supplemental oxygen during exercise and recovery, however, breathing supplemental oxygen via specialist facemasks is often not feasible. Therefore, this study investigated the effect of an oxygen-nanobubble beverage during submaximal and repeated sprint cycling. In a double-blind, randomized, placebo-controlled study, 10 male cyclists (peak aerobic capacity, 56.9 ± 6.1 mL·kg−1·min−1; maximal aerobic power, 385 ± 25 W) completed submaximal or maximal exercise after consuming an oxygen-nanobubble (O2) or placebo (PLA) beverage. Submaximal trials comprised 30-min of steady-state cycling at 60% peak aerobic capacity and 16.1-km time-trial (TT). Maximal trials involved 4 × 30 s Wingate tests interspersed by 4-min recovery. Time-to-completion during the 16.1-km TT was 2.4% faster after O2 compared with PLA (95% CI = 0.7–4.0%, p = 0.010, d = 0.41). Average power for the 16.1-km TT was 4.1% higher for O2 vs. PLA (95% CI = 2.1–7.3%, p = 0.006, d = 0.28). Average peak power during the repeated Wingate tests increased by 7.1% for O2 compared with PLA (p = 0.002, d = 0.58). An oxygen-nanobubble beverage improves performance during submaximal and repeated sprint cycling, therefore may provide a practical and effective ergogenic aid for competitive cyclists.

A Laboratory Test of Alcohol-Related Intimate Partner Aggression: Expectancies Are Not to Blame

Background: The role of alcohol expectancies and evaluations (i.e., perceived outcomes of drinking and whether these outcomes are desirable) in alcohol-related intimate partner aggression (IPA) has been debated, with some researchers arguing that expectancies fully account for the alcohol-IPA relationship and others suggesting they play a minimal if any role in alcohol-related IPA. In the current study, we examine the impact of expectancies and evaluations on alcohol-related IPA observed in the lab, in order to clarify what impact, if any, alcohol expectancies have on alcohol-related IPA. Consistent with findings from laboratory studies examining general aggression, we expected that individuals who were intoxicated would display greater IPA than individuals who were sober, but that alcohol expectancies and evaluations would be unrelated to in vivo IPA. Method: Participants were 69 dating couples (total N = 138), randomly assigned to consume either an alcohol or placebo beverage. IPA was measured with an in vivo aggression task based on the Taylor Aggression Paradigm. Results: As expected, alcohol intoxication predicted in vivo IPA following provocation (p < .03), whereas alcohol expectancies and evaluations were not related to IPA. Conclusions: These findings provide further support that alcohol expectancies and evaluations play little if any role in alcohol-related IPA. Rather, intoxication likely increases risk for IPA through its physiological effects on perception and thought. Further, treatments targeting alcohol use, rather than beliefs about outcomes of drinking, may have a greater impact on alcohol-related IPA.

Post-exercise skimmed milk, but not a sucrose beverage decreases energy intake at the next meal compared to a placebo beverage in active males

This study compared the appetite and energy intake effects of three post-exercise beverages at a subsequent post-exercise meal. On three occasions, ten active males: (mean ± sd) age 21.3 ± 1.2 y, V˙ O2peak 58 ± 5 mL/kg/min) performed 30-min cycling at ∼60% V˙ O2peak and five 4-min intervals at 85% V˙ O2peak. Post-exercise, placebo (PLA: 57 kJ), skimmed milk (MILK: 1002 kJ) or sucrose (CHO: 1000 kJ) beverages (615 mL) were consumed. Sixty min post-beverage, subjects consumed an ad-libitum pasta lunch in a 30 min eating period. Subjective appetite and plasma acylated ghrelin and plasma glucose were determined pre-exercise, post-exercise and pre-meal, with sensory characteristics of beverages rated. Ad-libitum energy intake in MILK (6746 ± 2035) kJ) was lower than CHO (7762 ± 1921) kJ) (P = 0.038; dz = 0.98; large effect) and tended to be lower than PLA (7672 (2005) kJ) (P = 0.078; dz = 0.76; medium effect). Including energy consumed in beverages, energy intake was greater in CHO than PLA (P = 0.010; dz = 1.24; large effect) or MILK (P = 0.026; dz = 0.98; large effect), with PLA and MILK not different (P = 0.960; dz = 0.02; trial effect). Plasma ghrelin, plasma glucose and appetite were not different between trials. MILK was perceived thicker than CHO (P = 0.020; dz = 1.11; large effect) and creamier than PLA (P = 0.026; dz = 1.06; large effect). These results suggest that when energy balance is important for an exerciser, post-exercise skimmed milk ingestion reduces energy intake compared to a sucrose beverage and might therefore help facilitate recovery/adaptation without affecting energy balance.

The Effect of Alcohol and Sexual Arousal on Explicit and Implicit Condom Attitudes and Intentions to Use a Condom

Alcohol and sexual arousal are contextual determinants of condomless sex. Dual-process theory postulates that two types of cognitive processing contribute to the regulation of behavior: one that is fast, intuitive and automatic, and another that is slower and deliberative. This study applied a dual-process model to investigate condomless sexual behavior, highlighting the potential importance of implicit attitudes in condomless sex. We investigated whether the impact of alcohol and sexual arousal on condom use-related attitudes and intentions was explained by diminished working memory capacity, as dual-process models suggest. We also investigated whether this effect could be explained by implicit and explicit attitudes toward condom use. Male participants (N = 30) were randomized using a 2 × 2 within-subjects design that manipulated alcohol intoxication (placebo vs. alcohol beverages) and sexual arousal (neutral vs. erotic movie clips). We measured participants’ working memory capacity, intentions to use a condom, and explicit and implicit attitudes toward condom use. Significant main effects of alcohol intoxication and sexual arousal on working memory capacity were found. No significant interaction was found for the combined effect of alcohol intoxication and sexual arousal on intentions to use a condom. There was no significant effect of implicit attitudes on intentions to use a condom, although a trend toward significance (p = 0.06) was found for the effect of implicit attitudes on intentions to use a condom when participants were in a state of alcohol intoxication. Theoretical and practical implications of this study are discussed.

Neural underpinnings of expecting alcohol: Placebo alcohol administration alters nucleus accumbens resting state functional connectivity

BackgroundUsing balanced placebo designs, seminal alcohol administration research has shown individuals’ beliefs about whether they have consumed alcohol, irrespective of the actual presence of alcohol, can determine level of alcohol consumption and impact social behavior. Despite the known effect of expecting alcohol on drinking behavior, few studies have used the placebo manipulation to directly investigate the neural underpinnings of the expectancy-related effects that occur following perceived alcohol consumption in humans. The present paper examined placebo responses in the laboratory to better understand the neural basis for the psychological phenomenon of expectancies. MethodsAs part of a larger within-subjects study design, healthy young adults (N = 22, agemean+SD=23 +1) completed resting state fMRI scans and measures of subjective response before and after consuming placebo beverages. Effect of placebo beverage consumption (pre- versus post-beverage consumption) on functional connectivity within prefrontal cortical networks was examined using the CONN Toolbox. Relations between perceived subjective response to alcohol with functional connectivity response following placebo beverage consumption were examined. ResultsCompared to pre-beverage scan, placebo beverage consumption was associated with increased positive functional connectivity between right nucleus accumbens – ventromedial prefrontal cortex and subcallosal cingulate cortex (pFDR<0.05). Subjective ratings of intoxication (i.e., feeling ‘drunk’) positively correlated with placebo beverage-related increases in nucleus accumbens – subcallosal cingulate cortex functional connectivity. ConclusionResults suggest placebo response to alcohol is associated with increased functional connectivity within a key reward network (nucleus accumbens – ventromedial prefrontal cortex and subcallosal cingulate cortex) and put forth a mechanism by which alcohol expectancies may contribute to the subjective experience of intoxication.

The effects of oral and vaporized cannabis alone, and in combination with alcohol, on driving performance using the STISIM driving simulator: A two-part, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory protocol.

The legalization of cannabis for medicinal and non-medicinal purposes, and the corresponding increase in diversity of cannabis products, has resulted an urgent need for cannabis regulatory science. Among the most pressing needs is research related to impairment due to cannabis exposure, especially on driving performance. The present project was designed to evaluate the impact of oral and vaporized cannabis, when administered alone or in combination with alcohol, on simulated driving performance (STISIM driving simulator), cognitive/psychomotor ability, and field sobriety performance. Healthy adults will complete two, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory studies, one with oral cannabis (16 men/16 women) and the second with vaporized cannabis (16 men/16 women). In each study, participants will complete seven experimental sessions during which acute doses of placebo or high Δ9-THC cannabis containing 0, 10, or 25 mg Δ9-THC will be administered both alone and in combination with placebo or alcohol-containing beverages (target breath alcohol concentrations, BAC, of 0.0% or 0.05%). A positive control session (i.e., alcohol at target BAC of 0.08% with placebo cannabis) will also be completed. Simulated driving performance tests (available for download; see Methods), field sobriety assessments, subjective drug effect questionnaires, a mobile device impairment test (DRUID app), and collection of whole blood specimens will be completed repeatedly during each session. Linear mixed models will be used to test for differences across experimental conditions and a priori planned comparisons will be used to determine differences between conditions of interest (e.g., cannabis alone vs cannabis with alcohol). This research is designed to extend prior studies of cannabis and alcohol on driving performance by using oral and vaporized routes of cannabis administration. By increasing understanding of impairment associated with co-use of alcohol and these novel forms of cannabis, this research could inform impairment detection standards for cannabis and alcohol and have important implications for law enforcement, public policy decisions regarding accessibility of these substances, and education of the general population who may use cannabis and/or alcohol. Lastly, this manuscript provides interested researchers with access to the simulated driving scenarios and data extraction tools developed for this study as a means of facilitating future cross-study comparisons, which is important given the heterogeneity in methods used across laboratories in prior research.