NCT05528575

Polyphenols, Prebiotics, the Gut Microbiome and Stress

Randomised Three-arm Trial Investigating the Effects of Different Polyphenol and Prebiotic Combinations on Human Gut Microbiota and Perceived Cognitive State

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Stress, Psychological
• Gut Bacteria

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Blueberry, cranberry, green tea extract, cocoa	tablet supplements, available readily.
DIETARY_SUPPLEMENT	GOS, Inulin, RS2	Prebiotic combination, Inulin, GOS and RS2
DIETARY_SUPPLEMENT	prebiotics and polyphenols	combination of the same prebiotics and polyphenols as above
DIETARY_SUPPLEMENT	Maltodextrin	maltodextrin, 10g per day

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2022-09-06
• Last updated: 2023-03-07

Locations

1 site across 1 country: United Kingdom