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

Pilot Clinical Trial on the Effects of Dietary Fibres on the Gut Microbiome and Metabolic Profiles in a Transgenerational Cohort

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.

Study Overview

• Status: Completed
• Conditions: Gut Health
• Intervention / Treatment: Dietary supplement: Dietary Fibres Supplement; Dietary supplement: Cellulose Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • NIHR Imperial Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mothers; Parent to the Daughter	Dietary supplement: 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.; 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.
Active Comparator: daughter; Child of Mother	Dietary supplement: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters	Alpha diversity (a measure of the gut microbiota composition) was compared between generations after taking each dietary supplement for 14 days.	14 days
Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement	Changes in urine metabolites types and levels after each generation took both supplements	14 days
Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement	Changes in stool metabolites types and levels between mothers and daughters after taking each supplement. Comparisons done: mothers on dietary fibres supplement versus daughters on dietary fibre supplement and mothers on cellulose control versus daughters on cellulose control	14 days
Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days	Fasted blood glucose levels in mothers and daughters after each generation took each supplement	14 days
Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days	Postprandial blood glucose levels comparison between mothers and daughters after each generation took each supplement for 14 days. The data is presented as incremental area under the curve.	240 minutes
Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements	Fasted blood insulin levels comparison between mothers and daughters after each generation took the dietary supplements for 14 days	14 days
Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days	Postprandial blood insulin levels comparison between mothers and daughters after each generation took the supplements (dietary fibre and cellulose) for 14 days	14 days
Gut Hormones in Mothers Versus Daughters	Fasted gut hormones levels in mothers after they took the dietary fibre supplement compared to fasted gut hormones in daughters after they took the dietary fibre supplements. Fasted gut hormones levels in mothers after they took the cellulose control compared to fasted gut hormones in daughters after they took the cellulose control.	14 days
Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement	Postprandial gut hormones levels were compared in mothers after they took the dietary fibre supplements against postprandial gut hormone levels in daughters after they took the dietary fibre supplement. Postprandial gut hormones levels were compared in mothers after they took the cellulose control against postprandial gut hormone levels in daughters after they took the cellulose control.	14 days

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Biotechnology and Biological Sciences Research Council; Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Gary Frost, PhD, RD, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: gut microbiota; generation; dietary fibres; metabolic profiles
• Other Study ID Numbers: 20HH5806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results of the study will be shared in the form of a research article or presented at scientific conferences. All results will be presented as group data rather than results for each volunteer.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No