Skip to main content
OpenTrials
Completed

NCT Number: NCT05528575

Polyphenols, Prebiotics, the Gut Microbiome and Stress

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, rg66dz, United Kingdom

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteer is healthy at the time of pre-examination
  • Volunteer has high perceived stress levels (own self-assessment)
  • Volunteer is aged ≥ 18 to ≤ 65 years at the time of pre-examination
  • Volunteer is able and willing to comply with the study instructions
  • Volunteer is suitable for participation in the study according to the investigator/study personnel
  • Written informed consent is given by volunteer

Exclusion criteria

  • No command of any local language
  • Gastrointestinal disorders including IBS, IBD or other conditions that might affect the gut environment
  • Food allergies or intolerances
  • Using drugs (e.g. antibiotics) influencing gastrointestinal function (8 weeks before intervention)
  • Use of laxatives
  • Participants with any form of diagnosed diabetes (types I and II)
  • Volunteers currently involved or will be involved in another clinical or food study
  • History of drug (pharmaceutical or recreational) or alcohol abuse.
  • participants are pregnant or are lactating
  • Regular intake of probiotic or prebiotic supplements
  • Smoking

Treatment and study plan

Blueberry, cranberry, green tea extract, cocoa

Dietary Supplement

tablet supplements, available readily.

GOS, Inulin, RS2

Dietary Supplement

Prebiotic combination, Inulin, GOS and RS2

prebiotics and polyphenols

Dietary Supplement

combination of the same prebiotics and polyphenols as above

Maltodextrin

Dietary Supplement

maltodextrin, 10g per day

Primary outcomes

  1. Bacteriology

    Time frame: baseline, pre-intervention, then After 14 days of intervention

    Changes in bacteriology

  2. Mood Questionnaires

    Time frame: baseline, pre-intervention, then After 14 days of intervention

    various mood questionnaires

Secondary outcomes

  1. Blood pressure

    Time frame: baseline, pre-intervention, then After 14 days of intervention. at least three times per week also

    Blood pressure taken systolic, diastolic and pulse

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2022
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.