Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-01-01
2022-09-23
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Polyphenol
Consume polyphenol combination for two weeks
Blueberry, cranberry, green tea extract, cocoa
tablet supplements, available readily.
Prebiotic
Consume prebiotic combination for two weeks
GOS, Inulin, RS2
Prebiotic combination, Inulin, GOS and RS2
prebiotic and polyphenol
Combination of prebiotics and polyphenols for two weeks
prebiotics and polyphenols
combination of the same prebiotics and polyphenols as above
Placebo
maltodextrin placebo for two weeks
Maltodextrin
maltodextrin, 10g per day
Interventions
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Blueberry, cranberry, green tea extract, cocoa
tablet supplements, available readily.
GOS, Inulin, RS2
Prebiotic combination, Inulin, GOS and RS2
prebiotics and polyphenols
combination of the same prebiotics and polyphenols as above
Maltodextrin
maltodextrin, 10g per day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
University of Reading
OTHER
Responsible Party
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Glenn Gibson
Professor of Food Microbiology
Locations
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University of Reading
Reading, Berkshire, United Kingdom
Countries
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Other Identifiers
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21/19
Identifier Type: -
Identifier Source: org_study_id
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