Gut Health
Conditions
Keywords
dietary fibres, gut microbiota, generation, metabolic profiles
Brief 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.
Interventions
DIETARY_SUPPLEMENTDietary 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_SUPPLEMENTCellulose Control
The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.
Sponsors
Biotechnology and Biological Sciences Research Council
Société des Produits Nestlé (SPN)
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double-blinded, randomised, cross-over
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement | 14 days | Changes in urine metabolites types and levels after each generation took both supplements |
| Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement | 14 days | 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 |
| Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days | 14 days | Fasted blood glucose levels in mothers and daughters after each generation took each supplement |
| Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days | 240 minutes | 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. |
| Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters | 14 days | Alpha diversity (a measure of the gut microbiota composition) was compared between generations after taking each dietary supplement for 14 days. |
| Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days | 14 days | Postprandial blood insulin levels comparison between mothers and daughters after each generation took the supplements (dietary fibre and cellulose) for 14 days |
| Gut Hormones in Mothers Versus Daughters | 14 days | 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. |
| Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement | 14 days | 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. |
| Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements | 14 days | Fasted blood insulin levels comparison between mothers and daughters after each generation took the dietary supplements for 14 days |
Countries
United Kingdom
Participant flow
Recruitment details
Volunteers recruited by study advert Study start date 2022-10-04 Study end date 2023-04-04
Pre-assignment details
The intervention is dietary fibres so wash out is necessary to allow the physiological measurements to return to baseline level.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Mothers | Daughter | Total |
|---|---|---|---|
| Age, Categorical participants <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical participants >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical participants Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Continuous | 57.6 years STANDARD_DEVIATION 2.1 | 26.7 years STANDARD_DEVIATION 1.9 | 41.6 years STANDARD_DEVIATION 4.3 |
| Fasted HbA1C | 37.75 mmol/l STANDARD_DEVIATION 1.1 | 33.38 mmol/l STANDARD_DEVIATION 0.93 | 35.56 mmol/l STANDARD_DEVIATION 0.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United Kingdom | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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
Time frame: 14 days
Population: Mothers and daughters data after taking the dietary fibre supplement for 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mothers Dietary Fibre Supplement | Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters | 50 umol/g | Standard Error 0.176 |
| Mothers Cellulose Control | Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters | 26 umol/g | Standard Error 0.709 |
| Daughters Dietary Fibre Supplement | Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters | 41.7 umol/g | Standard Error 0.106 |
| Daughters Cellulose Control | Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters | 47.8 umol/g | Standard Error 0.126 |
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.
Time frame: 240 minutes
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
Time frame: 14 days
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
Time frame: 14 days
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
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 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.
Time frame: 14 days
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
Time frame: 14 days
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
Time frame: 14 days