Pilot Clinical Trial on the Effects of Dietary Fibres on the Gut Microbiome and Metabolic Profiles in a Transgenerational Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- 未提供
结局指标
主要结局
Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters
时间窗: 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
次要结局
- Blood Glucose in Mothers Compared to Daughters After Taking Each Supplement for 14 Days(14 days)
- Gut Microbiota Composition Changes Following Each Supplement Intake Between Mothers and Daughters(14 days)
- Urine Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement(14 days)
- Stool Metabolites Comparison Between Mothers and Daughters After Taking Each Supplement(14 days)
- Blood Glucose for Mothers and Daughters After Taking Each Supplement for 14 Days(240 minutes)
- Blood Insulin Comparison Between Mothers and Daughters After Each Generation Took the Dietary Supplements(14 days)
- Blood Insulin Comparison Between Mothers and Daughters After Taking Each Supplement for 14 Days(14 days)
- Gut Hormones in Mothers Versus Daughters(14 days)
- Gut Hormones in Mothers Who Took Each Dietary Supplement Versus Gut Hormones in Daughters Who Took Each Dietary Supplement(14 days)