Clinical Research Directory

The Effects of a Postbiotic Supplement on Biomarkers of Gut Health

This study is a randomized, double-blind, two-arm, placebo-controlled trial of N=80 (40/arm) apparently healthy men and women between 18 and 65 years old to be recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). This study will assess the effectiveness of a postbiotic supplement on various biomarkers of health. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease. Participants will attend three in-person study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). Over the next 4 weeks, participants will attend two in-person visits: \[visit 2 (week 0) and visit 3 (week 4)\] wherein assessments of gut function \[fecal microbiome diversity, short chain fatty acids (SCFA), and fecal butyrate\], serum butyrate, serum zonulin, salivary cortisol, and Gastrointestinal Symptom Rating Scale (GSRS) for gastrointestinal (GI) health, emotional states \[Depression, Anxiety and Stress Scale (DASS21)\], and quality of life (SF-36 questionnaire) will be assessed. Participants will also be provided home kits with instructions on how to collect stool and saliva samples on two separate occasions (i.e., visit 2, visit 3) during the study. • Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure participant safety and scientific integrity of the data.

Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men

The goal of this study is to learn how different amounts of supervised indoor cycling training change gut health (gut bacteria, the substances gut bacteria make, and the gut barrier integrity), and how these changes relate to changes in fitness, muscle health, and signs of doing too much training (a state called 'overreaching'). The study includes healthy, recreationally active men aged 18 to 45 years. The primary questions, for which the study is powered (sufficient participants included), are: 1. Does moderate load training change blood and faecal levels of butyrate (a short-chain fatty acid made by gut bacteria) after eight weeks compared with a control group? 2. Compared to moderate load training, do higher training loads lead to different responses in blood and faecal levels of butyrate? Researchers will compare: * A control group that does not complete structured training; * A moderate-load training group that completes eight weeks of supervised cycling (4x/week); * A high-load training group that completes four weeks of moderate-load training followed by four weeks of higher training load (twice the number of training sessions). Participants will: * Be randomly assigned to one of the three groups; * Complete 8 weeks of supervised indoor cycling sessions if assigned to a training group; * Complete four study assessment periods (baseline, after week four, after week eight, and after a short taper (rest period); * Provide blood, stool, skeletal muscle, urine, saliva, and breath samples during the assessment periods; * Complete fitness and performance tests and questionnaires during the assessment periods.