Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Appetite_Food Intake
研究概览
简要总结
This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.
详细描述
This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers aged between 21 and 65 years
排除标准
- •Weight change of more than 3kg in the preceding 2 months
- •Current smokers
- •Substance abuse
- •Excess alcohol intake
- •Pregnancy
- •Cardiovascular disease
- •Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- •Kidney disease
- •Liver disease
- •Pancreatitis
- •Use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.
研究组 & 干预措施
Propionate ester
干预措施: Propionate ester (Dietary Supplement)
Fermentable control
干预措施: Inulin (Dietary Supplement)
Non fermentable control
干预措施: Cellulose (Dietary Supplement)
结局指标
主要结局
Appetite_Food Intake
时间窗: Baseline, 24 weeks
The change in food intake following 24 weeks of supplementation
Body Weight
时间窗: Baseline, 24 weeks
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
时间窗: Baseline, 24 weeks
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
次要结局
- Adipose Tissue Distribution - Intra-abdominal Adipose Tissue(24 weeks)
- Insulin Sensitivity - HOMA IR(24 weeks)