NCT05364437

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gut Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-04
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2022-05-06
• Last updated: 2025-04-29
• Results posted: 2025-04-29

Locations

1 site across 1 country: United Kingdom