Clinical trial NCT05364437: Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort
Official title: Pilot Clinical Trial on the Effects of Dietary Fibres on the Gut Microbiome and Metabolic Profiles in a Transgenerational Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Keywords: dietary fibres
gut microbiota
generation
metabolic profiles
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Biotechnology and Biological Sciences Research Council
name: Société des Produits Nestlé (SPN)
First posted: 2022-05-06
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded, randomised, cross-over
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters
timeFrame: 14 days
Secondary outcomes:
measure: Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters
timeFrame: 14 days
measure: Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement
timeFrame: 14 days
measure: Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement
timeFrame: 14 days
measure: Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days
timeFrame: 14 days
measure: Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days
timeFrame: 240 minutes
measure: Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements
timeFrame: 14 days
measure: Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days
timeFrame: 14 days
measure: Gut Hormones in Mothers Versus Daughters
timeFrame: 14 days
measure: Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement
timeFrame: 14 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: NIHR Imperial Clinical Research Facility
Study officials:
affiliation: Imperial College London
name: Gary Frost, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: