Polyphenols, Prebiotics, the Gut Microbiome and Stress
Primary Purpose
Stress, Psychological, Gut Bacteria
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blueberry, cranberry, green tea extract, cocoa
GOS, Inulin, RS2
prebiotics and polyphenols
Maltodextrin
Sponsored by
About this trial
This is an interventional prevention trial for Stress, Psychological
Eligibility Criteria
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
Sites / Locations
- University of Reading
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Polyphenol
Prebiotic
prebiotic and polyphenol
Placebo
Arm Description
Consume polyphenol combination for two weeks
Consume prebiotic combination for two weeks
Combination of prebiotics and polyphenols for two weeks
maltodextrin placebo for two weeks
Outcomes
Primary Outcome Measures
Bacteriology
Changes in bacteriology
Mood Questionnaires
various mood questionnaires
Secondary Outcome Measures
Blood pressure
Blood pressure taken systolic, diastolic and pulse
Full Information
NCT ID
NCT05528575
First Posted
August 24, 2022
Last Updated
March 6, 2023
Sponsor
University of Reading
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05528575
Brief Title
Polyphenols, Prebiotics, the Gut Microbiome and Stress
Official Title
Randomised Three-arm Trial Investigating the Effects of Different Polyphenol and Prebiotic Combinations on Human Gut Microbiota and Perceived Cognitive State
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Gut Bacteria
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyphenol
Arm Type
Experimental
Arm Description
Consume polyphenol combination for two weeks
Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
Consume prebiotic combination for two weeks
Arm Title
prebiotic and polyphenol
Arm Type
Experimental
Arm Description
Combination of prebiotics and polyphenols for two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
maltodextrin placebo for two weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry, cranberry, green tea extract, cocoa
Intervention Description
tablet supplements, available readily.
Intervention Type
Dietary Supplement
Intervention Name(s)
GOS, Inulin, RS2
Intervention Description
Prebiotic combination, Inulin, GOS and RS2
Intervention Type
Dietary Supplement
Intervention Name(s)
prebiotics and polyphenols
Intervention Description
combination of the same prebiotics and polyphenols as above
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
maltodextrin, 10g per day
Primary Outcome Measure Information:
Title
Bacteriology
Description
Changes in bacteriology
Time Frame
baseline, pre-intervention, then After 14 days of intervention
Title
Mood Questionnaires
Description
various mood questionnaires
Time Frame
baseline, pre-intervention, then After 14 days of intervention
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure taken systolic, diastolic and pulse
Time Frame
baseline, pre-intervention, then After 14 days of intervention. at least three times per week also
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
rg66dz
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Polyphenols, Prebiotics, the Gut Microbiome and Stress
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