Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort
NCT ID: NCT05364437
Last Updated: 2025-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2022-10-04
2023-04-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Mothers
Parent to the Daughter
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.
Cellulose Control
The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.
daughter
Child of Mother
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.
Cellulose Control
The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.
Interventions
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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.
Cellulose Control
The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.
Eligibility Criteria
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Inclusion Criteria
* Age 18-85 (inclusive)
* BMI: 18.5-30 kg/m2 (inclusive)
* Considering themselves healthy
Exclusion Criteria
* 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
18 Years
85 Years
FEMALE
Yes
Sponsors
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Biotechnology and Biological Sciences Research Council
OTHER
Société des Produits Nestlé (SPN)
INDUSTRY
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Gary Frost, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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NIHR Imperial Clinical Research Facility
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20HH5806
Identifier Type: -
Identifier Source: org_study_id
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