The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Faecal propionate concentrations.
研究概览
简要总结
The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects.
To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years
- •overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years
排除标准
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- •Gastroenterological diseases or abdominal surgery;
- •Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- •Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
- •Plans to lose weight or following of a hypocaloric diet;
- •Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
- •Intensive exercise training more than three hours a week;
- •Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
- •Regular use of laxation products;
- •Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- •Follow a vegan diet.
研究组 & 干预措施
Human milk-like oligosaccharide alone
12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day
干预措施: Human Milk Oligossaccharide (Dietary Supplement)
Human milk-like oligosaccharide and resistant starch
12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day
干预措施: Human Milk Oligossaccharide and resistant starch (Dietary Supplement)
Placebo
11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Faecal propionate concentrations.
时间窗: Fecal propionate will be sampled in the morning before the testday
On the day of clinical investigation day, fecal propionate will be sampled
Plasma acetate concentrations.
时间窗: plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
During the clinical investigation day plasma acetate will be sampled
Faecal acetate concentrations.
时间窗: Fecal acetate will be sampled in the morning before the testday
On the day of clinical investigation day, fecal acetate will be sampled
Plasma butyrate concentrations.
时间窗: plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma butyrate will be sampled
Fecal butyrate concentrations.
时间窗: Fecal butyrate will be sampled in the morning before the testday
On the day of clinical investigation day, fecal butyrate will be sampled
Plasma propionate concentrations.
时间窗: Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma propionate will be sampled
Plasma acetate concentrations.
时间窗: plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal
During the clinical investigation day plasma acetate will be sampled
Plasma acetate concentrations.
时间窗: plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal
During the clinical investigation day plasma acetate will be sampled
Plasma acetate concentrations.
时间窗: plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal
During the clinical investigation day plasma acetate will be sampled
Plasma butyrate concentrations.
时间窗: plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma butyrate will be sampled
Plasma butyrate concentrations.
时间窗: plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma butyrate will be sampled
Plasma butyrate concentrations.
时间窗: plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma butyrate will be sampled
Plasma propionate concentrations.
时间窗: Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma propionate will be sampled
Plasma propionate concentrations.
时间窗: Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma propionate will be sampled
Plasma propionate concentrations.
时间窗: Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal
During the clinical investigation day, plasma propionate will be sampled
次要结局
- Plasma FFA concentrations(Plasma FFA concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
- Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).(Breath H2 will be sampled during the CID before and at t=30, t=60, t=90, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
- Plasma glucose concentrations(Plasma glucose concentrations will be sampled during the CID before and t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
- Faecal microbiota composition(Faecal microbiota composition will be sampled in the morning before the testday)
- Energy expenditure, fat and carbohydrate oxidation(Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID)
- Plasma insulin concentrations(Plasma insulin concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)