Gut HealthNCT05364437
Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort
A study testing Dietary Fibres Supplement in people with Gut Health, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- Dietary Fibres Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2022to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Imperial Clinical Research Facility
London, W12 0HS
About this study
Official title: Pilot Clinical Trial on the Effects of Dietary Fibres on the Gut Microbiome and Metabolic Profiles in a Transgenerational Cohort
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.
Read the 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
- Being tested
- Dietary Fibres Supplement, Cellulose Control
- Keywords
- dietary fibres, gut microbiota, generation, metabolic profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fibres SupplementDietary 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 ControlDietary supplement
The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.
| Study group | Role | What they receive |
|---|---|---|
| Mothers | Active comparator | Parent to the Daughter Receives: Dietary Supplement: Dietary Fibres Supplement; Dietary Supplement: Cellulose Control |
| daughter | Active comparator | Child of Mother Receives: Dietary Supplement: Dietary Fibres Supplement; Dietary Supplement: Cellulose Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters
Changes in stool short-chain fatty acids production from baseline after each intervention (cellulose control and dietary fibre supplement) between mothers and daughters
Measured: 14 days
Secondary outcomes (9)
Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters
Alpha diversity (a measure of the gut microbiota composition) was compared between generations after taking each dietary supplement for 14 days.
Measured: 14 days
Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement
Changes in urine metabolites types and levels after each generation took both supplements
Measured: 14 days
Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement
Changes in stool metabolites types and levels between mothers and daughters after taking each supplement. Comparisons done: mothers on dietary fibres supplement versus daughters on dietary fibre supplement and mothers on cellulose control versus daughters on cellulose control
Measured: 14 days
Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days
Fasted blood glucose levels in mothers and daughters after each generation took each supplement
Measured: 14 days
Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days
Postprandial blood glucose levels comparison between mothers and daughters after each generation took each supplement for 14 days. The data is presented as incremental area under the curve.
Measured: 240 minutes
Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements
Fasted blood insulin levels comparison between mothers and daughters after each generation took the dietary supplements for 14 days
Measured: 14 days
Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days
Postprandial blood insulin levels comparison between mothers and daughters after each generation took the supplements (dietary fibre and cellulose) for 14 days
Measured: 14 days
Gut Hormones in Mothers Versus Daughters
Fasted gut hormones levels in mothers after they took the dietary fibre supplement compared to fasted gut hormones in daughters after they took the dietary fibre supplements.
Fasted gut hormones levels in mothers after they took the cellulose control compared to fasted gut hormones in daughters after they took the cellulose control.
Measured: 14 days
Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement
Postprandial gut hormones levels were compared in mothers after they took the dietary fibre supplements against postprandial gut hormone levels in daughters after they took the dietary fibre supplement.
Postprandial gut hormones levels were compared in mothers after they took the cellulose control against postprandial gut hormone levels in daughters after they took the cellulose control.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start4 Oct 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomised, cross-over
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
- Investigators
- Gary Frost, PhD, RD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364437
- Sponsor's protocol ID
- 20HH5806
- Status last verified
- Apr 2025
- First submitted
- 3 May 2022
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study will be shared in the form of a research article or presented at scientific conferences. All results will be presented as group data rather than results for each volunteer.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial on the Effects of Dietary Fibres on the Gut Microbiome and Metabolic Profiles in a Transgenerational Cohort
- ClinicalTrials.gov ID
- NCT05364437
- Acronym / sponsor ID
- 20HH5806
- Conditions
- Gut Health
- Keywords
- dietary fibres, gut microbiota, generation, metabolic profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Société des Produits Nestlé (SPN)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomised, cross-over
| Arm | Type | Receives |
|---|---|---|
| Mothers | Active comparator | Dietary Supplement: Dietary Fibres Supplement, Dietary Supplement: Cellulose ControlParent to the Daughter |
| daughter | Active comparator | Dietary Supplement: Dietary Fibres Supplement, Dietary Supplement: Cellulose ControlChild of Mother |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Fibres SupplementThe 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 | Mothers, daughter |
| Cellulose ControlThe control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food. | Dietary supplement | Mothers, daughter |
Primary outcome
Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters
Time frame: 14 days
Changes in stool short-chain fatty acids production from baseline after each intervention (cellulose control and dietary fibre supplement) between mothers and daughters
9 secondary outcomes
Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters
Time frame: 14 days
Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement
Time frame: 14 days
Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement
Time frame: 14 days
Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days
Time frame: 14 days
Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days
Time frame: 240 minutes
Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements
Time frame: 14 days
Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days
Time frame: 14 days
Gut Hormones in Mothers Versus Daughters
Time frame: 14 days
Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Results of the study will be shared in the form of a research article or presented at scientific conferences. All results will be presented as group data rather than results for each volunteer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Frost, PhD, RD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fibres Supplement in people with Gut Health, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.