Polyphenols, Prebiotics, the Gut Microbiome & Stress

Status Completed

Clinical Trial Summary

The aim of this study is to evaluate how different combinations of prebiotics and polyphenols affect the gut microbiota and perceived cognitive state. 40 volunteers will take part in this study who will be randomised into 4 different groups. One group will consume a placebo, whereas the other groups will consume prebiotics, polyphenols, or a combination of the two.

Clinical Trial Description

- All participants will be asked to fill out a health screening questionnaire and inclusion/exclusion criteria will be reviewed for volunteer eligibility - Valid informed consent will be obtained from the volunteer. - Once the study begins, participants will be randomly allocated into 1 of 4 groups each assigned a different polyphenol or prebiotic product. the prebiotic content is dosed as follows: Inulin at 5g/d, GOS at 5g/d and Resistant Starch at 20g/d. - Participants will be asked to consume their assigned product once per day. The length of the intervention is 14 days - Participants will provide two stool samples: one on day 0 and one on day 14 of the study to identify changes in gut microbiota composition - Urine samples will also be provided at day 0 and at day 14 looking for changes in urinary metabolites - Participants will also be asked to fill out various mood related questionnaires on days 0 and 14 of the study. - You will take your own blood pressure and heart rate on day 0 and day 14 and at least 3 times per week to try and link changes in gut microbiota composition with vascular health. - Volunteers will be given containers and specimen pots to take home for initial and final faecal and urine collections. No treatment will be issued until initial stool and urine sample has been provided - Maintenance of normal dietary patterns throughout the study is essential and participants will be required to complete food and drink logs throughout the study via a web-based app - on three consecutive days with one of the days being a weekend ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05528575
Study type	Interventional
Source	University of Reading
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2022
Completion date	September 23, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Polyphenols, Prebiotics, the Gut Microbiome and Stress

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms