Clinical Trials Logo

Clinical Trial Summary

The main aim of this randomized crossover study is to explore the effect of micronutrient supplementation on gut microbiota composition and function in healthy volunteers. Participants will undertake two 10-day trials with a replicated diet separated by a 15-day washout period. For one of these trials, participants will take a daily over-the-counter multivitamin supplement. Faecal and urine samples will be collected at the start and end of each trial to assess changes in gut microbiota composition, urinary and faecal metabolomics, and targeted bacterial metabolites including short chain fatty acids, sulphide, and lactate.


Clinical Trial Description

Exploring the effect of habitual dietary patterns on human gut microbiota and on host health is an area of scientific interest and a major funding theme in UKRI. The main aim of this proof-of-concept study is to explore the effect of micronutrient supplementation on gut microbiota composition and function in healthy volunteers. Participants will be asked to undertake two trials with 15 day washout in-between. If the participants are allocated to the "supplementation group" they will be asked to consume an over-the-counter multivitamin supplement for 10 days (1 tablet per day) in addition to their usual diet. Participants will provide faecal and urinary samples prior to initiation of the intervention and again at the end of the 10-day supplementation. During these 10 days participants will be asked to record the meals they consume on provided food diaries. If the participants are allocated to the "control group", participants will be asked to provide the same number of samples and at the same intervals as the supplementation group (i.e. at baseline and after 10 days) but without receiving micronutrient supplementation. Participants will also be asked to replicate as close as possible the diet they had followed during the first trial they were allocated. Between the two trials, participants will follow a wash-out period of 15 days with the aim of reverting the gut microbiota characteristics back to baseline levels. The main outcome measures of this study are to assess changes in gut microbiota composition based on 16S rRNA gene amplicon sequencing, changes in urinary/faecal metabolomics, and changes in targeted bacterial metabolites (short chain fatty acids, sulphide, lactate). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05371704
Study type Interventional
Source University of Glasgow
Contact
Status Active, not recruiting
Phase N/A
Start date September 28, 2021
Completion date February 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05961189 - Influence of Short-Term Antibiotic Therapy on Exercise Early Phase 1
Not yet recruiting NCT06126094 - Benefits of Alcoholic Hangover Medicine N/A
Completed NCT06087146 - Modulation of the Gut Microbiota of Professional Athletes With Sauerkraut Supplementation N/A
Not yet recruiting NCT05364736 - Effect of Prebiotics on Blood Pressure Management N/A
Completed NCT03949543 - The Timing of Main Meal Consumption Effect on Gut Microbiota and Host N/A
Recruiting NCT05636670 - Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease
Completed NCT02998177 - Characterization of Rebound Pain Following Peripheral Nerve Block and Its Association With Gut Microbiome Diversity N/A
Recruiting NCT05657730 - Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults N/A
Active, not recruiting NCT03978104 - Impact of Okara and Bio-okara Food Product on Gut and Glycaemic Health in Middle-aged and Older Adults in Singapore N/A
Terminated NCT04059666 - Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas N/A
Completed NCT04088474 - Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora N/A
Not yet recruiting NCT06332898 - The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life N/A
Completed NCT04046432 - Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora, Peristalsis, Immunity, and Anti-oxidative Capacity N/A
Completed NCT05729269 - Characterization of Gut Microbiota in Chronic Liver Disease With Decreased Muscle Mass
Recruiting NCT05692024 - COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER Phase 1/Phase 2
Not yet recruiting NCT06207136 - Microbiome and Diet in Parkinson's Disease N/A
Recruiting NCT03812445 - Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke N/A
Not yet recruiting NCT04947930 - Fecal Metagenomics and Metabolomics Analyses to Identify Potential Screening Biomarkers for Colorectal Polyps and Cancer in Chinese Population
Completed NCT02867605 - Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health N/A
Recruiting NCT04031469 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease