Short-chain Fatty Acids in Plasma After Intake of Fermentable Cereal Fibres- An Extended Postprandial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Differences in plasma propionate and butyrate concentration
研究概览
简要总结
Circulating SCFAs reflect the net effect of what is produced in the large intestine from dietary fibre fermentation, bioavailability after considerable absorption by the enterocytes and in the liver and the elimination. It is yet unclear to what extent SCFA levels in systemic circulation is of importance for metabolic disease risk and diabetes aetiology. Recent high-impact studies strongly suggest beneficial metabolic effects of butyrate and adverse effects from propionate However, no study has yet investigated to what extent butyrate or propionate producing diets may influence metabolic risk factors for T2D across individuals with different butyrate or propionate producing capacity. The overall aim is to investigate individual's ability to generate high concentrations of butyrate and propionate in plasma after acute intake of different fibre rich foods in an extended postprandial setting. The aim is further to optimize time points for data collection to allow robust assessment of plasma-time concentration profiles of butyrate and propionate to establish a screening approach to identify individuals with high/low butyrate/propionate plasma concentrations. This will be used in later precision nutrition studies where diet will be tailored to high/low SCFA-metabotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 20-35 kg/m2
- •Waist circumference >102 cm (males) or 88 cm (females)
- •Haemoglobin, low density lipoprotein (LDL) cholesterol or triglycerides within the normal reference ranges (age and sex specific) according to the laboratory analysing the screening samples.
- •Willing to collect faecal samples at home and store them in their household freezer
排除标准
- •Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
- •Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.
- •Diastolic blood pressure ³ 105 mm Hg at visit 1
- •Systolic blood pressure ³ 160 mm at visit 1
- •History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption etc.)
- •More than 10 hours physical activity per week
- •History of heart failure or heart attack within 1 year prior to screening
- •Having type I and type 2 diabetes
- •Previous gastrointestinal surgery (e.g., gastric bypass, gastric sleeve, bowel resection, colostomy etc.), with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
- •Thyroid disorder not controlled by drug therapy
- •History of drug or alcohol abuse
- •Stroke or transient ischemic attack (TIA) within 1 year prior to screening
- •Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
- •Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
- •Food allergies or intolerances preventing consumption of any products included in the study
- •Strict vegetarian/vegan (participants must be able to consume the standardized meals used in the study)
结局指标
主要结局
Differences in plasma propionate and butyrate concentration
时间窗: 24 hours
Differences in plasma SCFA concentration- time profiles , with emphasis on butyrate and propionate concentrations after intake of the breakfast meals cointaned the same amount of different fibre sources (wheat bran puff and Arabynoxylans bread) compared to control fiber (extruded vitacel puff). Plasma SCFAs concentration was evaluated by LC-MS analysis
次要结局
- Effects of the different fibres sources on plasma glucose(24 hours)
- Effects of the different fibres sources on plasma GLP-1(24 hours)
- Effects of the different fibres sources on plasma insulin(24 hours)
- Effects of the different fibres sources on plasma free fatty acids(24 hours)
- Gut microbiota composition(24 hours)
研究者
rivellese angela
Full Professor
Federico II University