Acute Microbial Switch Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- 24 hour intestinal gas concentrations
研究概览
简要总结
In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo
Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.
详细描述
In this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. Additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.
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)
盲法说明
double-blinded
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
- •Lean normoglycemic individuals:
- •Lean (BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 );
- •Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2
- •Individuals with overweight/obesity and prediabetes/insulin resistance:
- •Overweight/obesity (BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 );
- •insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma glucose ≥ 5.6 mmol/l)
- •For both subject groups:
- •Aged 30 - 75 years;
- •Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure 60-100 mmHg);
- •Weight stable for at least 3 months (± 2 kg)
排除标准
- •T2DM (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- •Gastroenterological diseases
- •Abdominal surgery affecting the GI tract;
- •Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years;
- •Abuse of products;
- •Alcohol (> 15 standard units per week)
- •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 three months prior to the start of the study;
- •Intensive exercise training more than three hours a week;
- •Use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., PPAR γ or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory* or immunosuppressive drugs) and anti-oxidants;
- •Regular use of laxatives;
- •Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- •Lactose intolerance
- •For women: pregnancy or lactation
研究组 & 干预措施
lean normoglycaemic individuals fiber mixture
Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch
干预措施: Two day supplementation of a complex fiber mixture (Dietary Supplement)
lean normoglycaemic placebo
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
干预措施: Placebo supplementation (Dietary Supplement)
overweight and/or obesity and prediabetes/insulin fiber mixture
Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch
干预措施: Two day supplementation of a complex fiber mixture (Dietary Supplement)
overweight and/or obesity and prediabetes/insulin resistance placebo
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
干预措施: Placebo supplementation (Dietary Supplement)
结局指标
主要结局
24 hour intestinal gas concentrations
时间窗: after ingestion of the supplement up until 24 hours after supplementation continuously
changes in intestinal gas excretion (methane, hydrogen or hydrogen sulphide will be measured using gas sensors in a modified respiration chamber)
次要结局
- 24 hour substrate metabolism(after ingestion of the supplement up until 24 hours after supplementation continuously)
- 24 hour energy expenditure(after ingestion of the supplement up until 24 hours after supplementation continuously)
- circulating blood markers(after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation)
- Fecal microbiota composition(at baseline and 24 hours after supplementation)
- fecal microbial metabolite concentrations(after ingestion of the supplement and 24 hours after supplementation)
- 24 hour glucose monitoring(after ingestion of the supplement up until 24 hours after supplementation)
- Urine metabolites(at baseline up until 24 hours after supplementation)