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Completed

NCT Number: NCT05364437

Investigation of the Effects of Dietary Fibres on the Gut Microbiome 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.

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Key information

Conditions

Gut Health

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NIHR Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 14 days

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

Secondary outcomes

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

    Time frame: 14 days

    Alpha diversity (a measure of the gut microbiota composition) was compared between generations after taking each dietary supplement for 14 days.

  2. Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement

    Time frame: 14 days

    Changes in urine metabolites types and levels after each generation took both supplements

  3. Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement

    Time frame: 14 days

    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

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

    Time frame: 14 days

    Fasted blood glucose levels in mothers and daughters after each generation took each supplement

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

    Time frame: 240 minutes

    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.

  6. Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements

    Time frame: 14 days

    Fasted blood insulin levels comparison between mothers and daughters after each generation took the dietary supplements for 14 days

  7. Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days

    Time frame: 14 days

    Postprandial blood insulin levels comparison between mothers and daughters after each generation took the supplements (dietary fibre and cellulose) for 14 days

  8. Gut Hormones in Mothers Versus Daughters

    Time frame: 14 days

    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.

  9. Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • Société des Produits Nestlé (SPN)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 6, 2022
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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