Polyphenols, Prebiotics, the Gut Microbiome and Stress

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528575
• Other study ID #: 21/19
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 23, 2022

Study information

• Verified date: March 2023
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Bacteria
• Stress, Psychological

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	United States Department of Defense

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriology	Changes in bacteriology	baseline, pre-intervention, then After 14 days of intervention
Primary	Mood Questionnaires	various mood questionnaires	baseline, pre-intervention, then After 14 days of intervention
Secondary	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