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

NCT05364437 | Completed Results

• 1 other identifier: 20HH5806
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Health

Keywords

dietary fibres; gut microbiota; generation; metabolic profiles

Outcome Measures

Primary Outcomes (1)

• Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters

  Changes in stool short-chain fatty acids production from baseline after each intervention (cellulose control and dietary fibre supplement) between mothers and daughters

  14 days

Secondary Outcomes (9)

• Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters

  14 days

• Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement

  14 days

• Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement

  14 days

• Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days

  14 days

• Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days

  240 minutes

Study Arms (2)

Mothers

ACTIVE COMPARATOR

Parent to the Daughter

Dietary Supplement: Dietary Fibres Supplement; Dietary Supplement: Cellulose Control

daughter

ACTIVE COMPARATOR

Child of Mother

Dietary Supplement: Dietary Fibres Supplement; Dietary Supplement: Cellulose Control

Interventions

Dietary Fibres Supplement 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.

Mothers; daughter

Cellulose Control DIETARY_SUPPLEMENT

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

Mothers; daughter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Biotechnology and Biological Sciences Research Council: collaborator
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

NIHR Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

Location

Results Point of Contact

• Title: Gary Frost
• Organization: Imperial College London

g.frost@imperial.ac.uk

07872850308

Study Officials

• Gary Frost, PhD, RD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, randomised, cross-over

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: October 4, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)