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

Gut Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364437
• Other study ID #: 20HH5806
• Status: Completed
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: May 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 placebo.

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 (placebo 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Health

Intervention

Dietary Supplement:
• Dietary Fibres Mix
The Fibre Mix, 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.
• Placebo
The placebo, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.

Locations

Country	Name	City	State
United Kingdom	NIHR Imperial Clinical Research Facility	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Biotechnology and Biological Sciences Research Council, Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-chain fatty acids production	Changes in short-chain fatty acids production from baseline	Baseline to 14 days
Secondary	Gut microbiota composition	Changes in gut microbiota composition from baseline	Baseline to 14 days
Secondary	Urine metabolites	Changes in urine metabolites types and levels from baseline	Baseline to 14 days
Secondary	Stool metabolites	Changes in stool metabolites types and levels from baseline	Baseline to 14 days
Secondary	Blood glucose	Fasted blood glucose levels	-15 and -5 minutes (before standardised breakfast is given at time point 0 minutes)
Secondary	Blood glucose	Postprandial blood glucose levels	240 minutes
Secondary	Blood insulin	Fasted blood insulin levels	-15 and -5 minutes (before standardised breakfast is given at time point 0 minutes)
Secondary	Blood insulin	Postprandial blood insulin levels	240 minutes
Secondary	Gut hormones	Fasted gut hormones levels	-15 and -5 minutes (before standardised breakfast is given at time point 0 minutes)
Secondary	Gut hormones	Postprandial gut hormones levels	240 minutes
Secondary	Food diaries information and gut microbiota	Correlation of dietary quality indices and gut microbiota composition	Three days before study visit
Secondary	Food diaries information and short-chain fatty acids	Correlation of dietary quality indices and short-chain fatty acids production	Three days before study visit
Secondary	Food diaries information and urine metabolic profiles	Correlation of dietary quality indices and urine metabolic profiles	Three days before study visit