Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort

NCT ID: NCT05364437

Last Updated: 2025-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2023-04-04

Brief Summary

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Dietary fibres are complex carbohydrates present in fruit, vegetables, grains, and beans which are broken down into smaller molecules (short-chain fatty acids) in the colon by the gut microbiota. Increased intake of dietary fibres is associated with a lower risk of type 2 diabetes, obesity, or heart disease. Despite their health benefits, most people consume half of the daily recommended intake (30 grams) of dietary fibres. This trend has become more apparent in the past few decades with the advent of ultra-processed foods which are poor in dietary fibres. Since this change in dietary habits is more recent, the research team hypothesizes that older generations have a more diverse and better adapted gut microbiota at breaking down dietary fibres compared to younger generations.

The aims of this study are to examine the effects of the daily intake over four weeks of a dietary fibres supplement on the gut microbiota, metabolic profiles, and general health in a transgenerational cohort (grandmother, mother and daughter OR mother and daughter) compared to cellulose control.

Detailed Description

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Eligible participants will need to take daily for 14 days a dietary fibre supplement or placebo (depending on the randomisation) followed by wash-out period of 14 days and then followed by taking daily for 14 days the opposite arm of intervention ( cellulose control or dietary fibre supplement). During the study period, participants will come to the research facility to assess the impact of these supplements on their gut microbiota, metabolic profiles and blood glucose, insulin and gut hormone levels.

Conditions

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Gut Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blinded, randomised, cross-over
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mothers

Parent to the Daughter

Group Type ACTIVE_COMPARATOR

Dietary Fibres Supplement

Intervention Type DIETARY_SUPPLEMENT

The dietary fibres supplement, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food.

Cellulose Control

Intervention Type DIETARY_SUPPLEMENT

The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.

daughter

Child of Mother

Group Type ACTIVE_COMPARATOR

Dietary Fibres Supplement

Intervention Type DIETARY_SUPPLEMENT

The dietary fibres supplement, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food.

Cellulose Control

Intervention Type DIETARY_SUPPLEMENT

The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.

Interventions

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Dietary Fibres Supplement

The dietary fibres supplement, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food.

Intervention Type DIETARY_SUPPLEMENT

Cellulose Control

The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Any of the following groups of people (in direct descent and from the same family) Grandmother, mother and daughter Mother and daughter Grandmother and granddaughter
* Age 18-85 (inclusive)
* BMI: 18.5-30 kg/m2 (inclusive)
* Considering themselves healthy

Exclusion Criteria

* Intake of antibiotics in the past 3 months and during the study
* Intake of probiotic supplements in the past month and during the study
* Regular intake of laxatives in the past month and during the study
* Subjects with the following conditions Inflammatory Bowel Disease (IBD) Irritable Bowel Syndrome (IBS) Coeliac Disease Type 2 Diabetes Any type of cancer Autoimmune conditions Conditions that affect the liver Conditions that affect the pancreas
* Subjects who require medical intervention in the coming 3 months
* Smokers
* Shift workers
* Gluten and/or lactose intolerance
* Pregnant and lactating women
* Subjects living in care homes
* had weight changes \>5% in the preceding 3 months
* Subjects who are unable to give informed consent by themselves
* Subjects who are currently participating in other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biotechnology and Biological Sciences Research Council

OTHER

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Frost, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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NIHR Imperial Clinical Research Facility

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20HH5806

Identifier Type: -

Identifier Source: org_study_id

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