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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Gut Bacteria
• Intervention / Treatment: Dietary supplement: Blueberry, cranberry, green tea extract, cocoa; Dietary supplement: prebiotics and polyphenols; Dietary supplement: Maltodextrin; Dietary supplement: GOS, Inulin, RS2

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, rg66dz
      • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyphenol; Consume polyphenol combination for two weeks	Dietary supplement: Blueberry, cranberry, green tea extract, cocoa; tablet supplements, available readily.
Experimental: Prebiotic; Consume prebiotic combination for two weeks	Dietary supplement: GOS, Inulin, RS2; Prebiotic combination, Inulin, GOS and RS2
Experimental: prebiotic and polyphenol; Combination of prebiotics and polyphenols for two weeks	Dietary supplement: prebiotics and polyphenols; combination of the same prebiotics and polyphenols as above
Placebo Comparator: Placebo; maltodextrin placebo for two weeks	Dietary supplement: Maltodextrin; maltodextrin, 10g per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteriology	Changes in bacteriology	baseline, pre-intervention, then After 14 days of intervention
Mood Questionnaires	various mood questionnaires	baseline, pre-intervention, then After 14 days of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure taken systolic, diastolic and pulse	baseline, pre-intervention, then After 14 days of intervention. at least three times per week also

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 21/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No