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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gut Health

Intervention / Treatment
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* Dietary Supplement: Dietary Fibres Mix
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blinded, randomised, cross-over
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Fibres Supplement<br>Dietary fibre mix comprising of inulin, pectin and oat beta-glucan. The mix comes in a powdered form which can be added to participants' food. | Dietary Supplement: Dietary Fibres Mix<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo comprising of cellulose which will come in a powdered form that can be added to participants' food. | Dietary Supplement: Placebo<br>* The placebo, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-chain fatty acids production | Changes in short-chain fatty acids production from baseline | Baseline to 14 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fibres, gut microbiota, generation, metabolic profiles