Long-term Effect of Cereal Fibre on Abdominal Fat in Insulin Resistant Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Serum acetate concentration
研究概览
简要总结
High intake of cereal fibre has been shown to be associated with reduced weight gain and improved insulin sensitivity. We hypothesize these effects are due to the short chain fatty acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large intestine). Insulin resistant subjects will be randomized to receive 2 servings of a low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal) per day for one year. The effects of the diets on body weight, appetite, abdominal fat, blood short chain fatty acids, glucose, insulin, lipids and hormones will be measured
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
- Single
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-diabetic male or non-pregnant females
- •aged 18-60
- •fasting insulin >40pmol/L (70%ile)
排除标准
- •intention to lose >5kg in weight
- •presence of diabetes (fasting glucose >6.9mmol/L)
- •use of diuretics, beta-blockers or weight reducing drugs
- •use of antibiotics in last 3 months and use of antibiotics more than once annually for the last 2 years
- •significant gastrointestinal, liver or kidney disease
- •use of lipid-lowering drug
- •major medical or surgical event in last 6 mo.
- •fibre intake >30g/d
- •inability to eat low or high fibre breakfast cereals
- •unwilling or unable to give consent or comply with protocol
结局指标
主要结局
Serum acetate concentration
时间窗: 0, 3, 6, 9 and 12 months
Serum butyrate concentration
时间窗: 0, 3, 6, 9 and 12 months
Plasma GLP-1 concentration
时间窗: 0, 3, 6, 9 and 12 months
次要结局
- HOMA insulin resistance and beta cell function(0, 3, 6, 9 and 12 months)
- postprandial glucose and insulin(0, 3, 6, 9 and 12 months)
- Fasting glucose and insulin(0, 3, 6, 9 and 12 months)
- Body weight(0, 3, 6, 9 and 12 months)
- waist circumference(0, 3, 6, 9 and 12 months)
- Abdominal fat(0 and 12 months)
- food intake(0, 3, 6, 9 and 12 months)
- Fasting lipids (cholesterol, triglyceride, HDL, LDL)(0, 3, 6, 9 and 12 months)
- Fasting and postprandial free fatty acids and triglycerides(0, 3, 6, 9 and 12 months)
- Fasting and postprandial c-peptide(0, 3, 6, 9 and 12 months)
- C-peptide/insulin ratio as marker of hepatic insulin extraction(0, 3, 6, 9 and 12 months)