NCT05528575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

August 24, 2022

Last Update Submit

March 6, 2023

Conditions

Stress, PsychologicalGut Bacteria

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Blood pressure

    baseline, pre-intervention, then After 14 days of intervention. at least three times per week also

Study Arms (4)

Polyphenol

EXPERIMENTAL

Consume polyphenol combination for two weeks

Dietary Supplement: Blueberry, cranberry, green tea extract, cocoa

Prebiotic

EXPERIMENTAL

Consume prebiotic combination for two weeks

Dietary Supplement: GOS, Inulin, RS2

prebiotic and polyphenol

EXPERIMENTAL

Combination of prebiotics and polyphenols for two weeks

Dietary Supplement: prebiotics and polyphenols

Placebo

PLACEBO COMPARATOR

maltodextrin placebo for two weeks

Dietary Supplement: Maltodextrin

Interventions

Blueberry, cranberry, green tea extract, cocoaDIETARY_SUPPLEMENT

tablet supplements, available readily.

Polyphenol
GOS, Inulin, RS2DIETARY_SUPPLEMENT

Prebiotic combination, Inulin, GOS and RS2

Prebiotic
prebiotics and polyphenolsDIETARY_SUPPLEMENT

combination of the same prebiotics and polyphenols as above

prebiotic and polyphenol
MaltodextrinDIETARY_SUPPLEMENT

maltodextrin, 10g per day

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, rg66dz, United Kingdom

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

blueberry extractTeaChocolateInulinPrebioticsPolyphenolsmaltodextrin

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFoodStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharidesDietary FiberPolysaccharides, BacterialDietary SupplementsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Food Microbiology

Study Record Dates

First Submitted

August 24, 2022

First Posted

September 6, 2022

Study Start

January 1, 2022

Primary Completion

September 23, 2022

Study Completion

September 23, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

GB(1)