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| Name | Class |
|---|---|
| Biotechnology and Biological Sciences Research Council | OTHER |
| Société des Produits Nestlé (SPN) | INDUSTRY |
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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 cellulose control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mothers | Active Comparator | Parent to the Daughter |
|
| daughter | Active Comparator | Child of Mother |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Fibres Supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gary Frost, PhD, RD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR Imperial Clinical Research Facility | London | W12 0HS | United Kingdom |
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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The intervention is dietary fibres so wash out is necessary to allow the physiological measurements to return to baseline level.
Volunteers recruited by study advert Study start date 2022-10-04 Study end date 2023-04-04
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| ID | Title | Description |
|---|---|---|
| FG000 | Mothers Dietary Fibres Supplement First Then Cellulose Control | 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. Four mothers took dietary fibre mix first. 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. This group of mothers took dietary fibre mix first and then they took the cellulose control after the wash-out period. |
| FG001 | Mothers Cellulose Control First Then Dietary Fibres Supplement | Control comprising of cellulose which will come in a powdered form that can be added to participants' food. Four mothers took the cellulose control first and then they took the dietary fibre mix supplement after the wash out period. Control: The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food. |
| FG002 | Daughters Dietary Fibres Supplement First Then Cellulose Control | Dietary fibre mix consisted of inulin, pectin and oat beta-glucan which the volunteers were able to add to their foods. The control consisted of cellulose which the participants were able to add to their foods. In this arm, the daughters took the dietary fibre supplement first and then they took the cellulose control following the wash-out period. Three daughters took the dietary fibre supplement first. |
| FG003 | Daughters Cellulose First Then Dietary Fibre Supplement. | The control consisted of cellulose which the volunteers added to their usual foods. This group of daughters took cellulose control first and then they took the dietary fibre mix after the wash-out period. In this group, five daughters took the cellulose control first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 1 |
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| Washout |
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| Study Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mothers | Parent to the Daughter in the placebo group 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Mothers and daughters data after taking the dietary fibre supplement for 14 days | Posted | Mean | Standard Error | umol/g | 14 days |
|
Adverse event data was collected throughout the time the volunteers were involved in the study. Specifically, adverse events were recorded for six weeks (two weeks on each intervention plus two weeks wash-out period).
Adverse events were recorded in the study file kept in locked cabinets in the NIHR Imperial clinical research facility.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietary Fibre Supplement | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Frost | Imperial College London | 07872850308 | g.frost@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2022 | Mar 24, 2025 | Prot_SAP_000.pdf |
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Double-blinded, randomised, cross-over
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| Cellulose Control | Dietary Supplement | The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food. |
|
Changes in urine metabolites types and levels after each generation took both supplements |
| 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 | 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 | 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. | 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 | 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 | 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. | 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. | 14 days |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Daughter | Child of Mother 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fasted HbA1C | Mean | Standard Deviation | mmol/l |
|
| OG002 | Daughters Dietary Fibre Supplement | Daughters took the dietary fibre supplement for 14 days |
| OG003 | Daughters Cellulose Control | Daughters took the cellulose control for 14 days. |
|
|
| Secondary | 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. | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement | Changes in urine metabolites types and levels after each generation took both supplements | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | 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 | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | 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 | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | 240 minutes | Participants |
| Secondary | 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 | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | 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 | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | 14 days | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | 14 days | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Cellulose Control | Control comprising of cellulose which will come in a powdered form that can be added to participants' food. Control: The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food. | 0 | 16 | 0 | 16 | 0 | 16 |
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