CirculAting Bile Acids as Biomarkers of Metabolic Health - Linking microbiotA, Diet and Health
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Circulating bile acids
研究概览
简要总结
During digestion of fatty foods, the liver produces a substance called bile which helps with the absorption of fat in the gut (small intestine). Some research studies have shown that friendly bacteria that live in our gut can change the makeup of bile (referred to as bile acids) leading to a lowering of blood cholesterol levels, an important risk factor for developing heart disease. This finding has been found in people who consume diets high in dietary fibers and probiotics that enhance the growth of friendly gut bacteria, and also plant rich foods high in polyphenols (such as apples). At present, very little is known about how the makeup of bile acids can regulate blood cholesterol levels and if their measurement in blood, urine or stool samples can be used as an indicator of human health.
The aim of this study is to explore how consumption of foods which enhance the growth of friendly gut bacteria (such as probiotics, prebiotics, and plant rich foods high in polyphenols) can change the makeup of bile acids after 8 weeks. Changes in the bile acids measured in blood and stool samples will then be related to markers of health, such as blood cholesterol, glucose, insulin, vascular health and inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Aged 25-70 years
- •BMI: 23-32 kg/m2
- •Fasting glucose < 7 mmol/l
- •Total cholesterol < 7.5 mmol/L
- •Triglycerides < 2.3 mmol/L
- •Habitual breakfast consumers
- •Weight stable in the last three months
排除标准
- •Endocrine disease
- •Cardiovascular disease diagnosis
- •Gastrointestinal diseases
- •Pancreatic, hepatic or renal diseases
- •Medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
- •Antibiotic use within the last three months
- •Food allergies (e.g. gluten, dairy, apples) and intolerances (e.g. lactose)
- •Alcohol or drug abuse (Drink more than 14 units of alcohol per week)
- •Anemia (men:haemoglobin<130g/ L and women <120 g/L
- •Planning or currently on a weight reducing program
- •Pregnancy, planned pregnancy in the next year or lactating
- •Irregular menstrual cycle
- •Planning or currently on a weight reducing program
- •Currently taking part or participation in other research studies within the last three months
- •Recent blood donation or unwilling to refrain from donating blood during the study
- •Regular consumption of probiotic or prebiotic food supplements or fiber based laxatives and unwilling stop consuming these for the duration of the study
结局指标
主要结局
Circulating bile acids
时间窗: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Plasma bile acid profile
次要结局
- Glucose response(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Gut hormones(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Metabolomics(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Blood lipid profile(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Gut microbiota(At baseline and week 8)
- Insulin response(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- C-peptide(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Nitric Oxide(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Cell-adhesion molecules(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- LDL receptor expression(This will be measured at baseline)
- Platelets(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Inflammatory markers(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Genotyping of bile acid receptor gene(This will be measured at baseline)
- Energy excretion(At baseline and week 8)
- Short-chain fatty acids(Chronic and acute effects: Fasting and 6-hour postprandial response and faecal sample at both baseline and week 8)
- Bile acid excretion(At baseline and week 8)
- Urine metabolites(At baseline and week 8)
- Blood pressure and heart rate(Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8)
- Body composition(At baseline and week 8)
研究者
Julie Lovegrove
Professor
University of Reading