Stress, PsychologicalNCT05528575
Polyphenols, Prebiotics, the Gut Microbiome and Stress
A study testing Blueberry, cranberry, green tea extract, cocoa, GOS, Inulin, RS2 and prebiotics and polyphenols in people with Stress, Psychological and Gut Bacteria, run by University of Reading at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Gut Bacteria
- What is being tested?
- Blueberry, cranberry, green tea extract, cocoa, GOS, Inulin, RS2 and prebiotics and polyphenols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Stress, Psychological, Gut Bacteria
- Being tested
- Blueberry, cranberry, green tea extract, cocoa, GOS, Inulin, RS2, prebiotics and polyphenols, Maltodextrin
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry, cranberry, green tea extract, cocoaDietary supplement
tablet supplements, available readily.
GOS, Inulin, RS2Dietary supplement
Prebiotic combination, Inulin, GOS and RS2
prebiotics and polyphenolsDietary supplement
combination of the same prebiotics and polyphenols as above
MaltodextrinDietary supplement
maltodextrin, 10g per day
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol | Experimental | Consume polyphenol combination for two weeks Receives: Dietary Supplement: Blueberry, cranberry, green tea extract, cocoa |
| Prebiotic | Experimental | Consume prebiotic combination for two weeks Receives: Dietary Supplement: GOS, Inulin, RS2 |
| prebiotic and polyphenol | Experimental | Combination of prebiotics and polyphenols for two weeks Receives: Dietary Supplement: prebiotics and polyphenols |
| Placebo | Placebo comparator | maltodextrin placebo for two weeks Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriology
Changes in bacteriology
Measured: baseline, pre-intervention, then After 14 days of intervention
Mood Questionnaires
various mood questionnaires
Measured: baseline, pre-intervention, then After 14 days of intervention
Secondary outcomes (1)
Blood pressure
Blood pressure taken systolic, diastolic and pulse
Measured: baseline, pre-intervention, then After 14 days of intervention. at least three times per week also
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Jan 2022
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Glenn Gibson, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528575
- Sponsor's protocol ID
- 21/19
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Three-arm Trial Investigating the Effects of Different Polyphenol and Prebiotic Combinations on Human Gut Microbiota and Perceived Cognitive State
- ClinicalTrials.gov ID
- NCT05528575
- Acronym / sponsor ID
- 21/19
- Conditions
- Stress, Psychological, Gut Bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polyphenol | Experimental | Dietary Supplement: Blueberry, cranberry, green tea extract, cocoaConsume polyphenol combination for two weeks |
| Prebiotic | Experimental | Dietary Supplement: GOS, Inulin, RS2Consume prebiotic combination for two weeks |
| prebiotic and polyphenol | Experimental | Dietary Supplement: prebiotics and polyphenolsCombination of prebiotics and polyphenols for two weeks |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrinmaltodextrin placebo for two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry, cranberry, green tea extract, cocoatablet supplements, available readily. | Dietary supplement | Polyphenol |
| GOS, Inulin, RS2Prebiotic combination, Inulin, GOS and RS2 | Dietary supplement | Prebiotic |
| prebiotics and polyphenolscombination of the same prebiotics and polyphenols as above | Dietary supplement | prebiotic and polyphenol |
| Maltodextrinmaltodextrin, 10g per day | Dietary supplement | Placebo |
Primary outcome
Bacteriology
Time frame: baseline, pre-intervention, then After 14 days of intervention
Changes in bacteriology
Mood Questionnaires
Time frame: baseline, pre-intervention, then After 14 days of intervention
various mood questionnaires
1 secondary outcome
Blood pressure
Time frame: baseline, pre-intervention, then After 14 days of intervention. at least three times per week also
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry, cranberry, green tea extract, cocoa, GOS, Inulin, RS2 and prebiotics and polyphenols in people with Stress, Psychological and Gut Bacteria, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteriology (time frame: baseline, pre-intervention, then After 14 days of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.