NCT03741660已完成2 期
Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- change in total:HDL cholesterol
研究概览
简要总结
To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hyperlipidemia controlled by medication
- •hypertension controlled by medication
- •type 2 diabetes controlled by medication
- •minimum 3 years since onset of all three conditions
- •sedentary lifestyle
排除标准
- •regular smoking
- •regular alcohol consumption
- •family history of premature coronary heart disease
- •hypothyroidism
- •renal, hepatic or gastrointestinal disease
研究组 & 干预措施
Konjac-mannan
Experimental
Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet
干预措施: konjac glucomannan (Dietary Supplement)
Placebo
Placebo Comparator
wheat bran fiber biscuits with NCEP Step II metabolically controlled diet
干预措施: wheat bran (Dietary Supplement)
结局指标
主要结局
change in total:HDL cholesterol
时间窗: change from baseline at week 3, relative to control
change in fructosamine
时间窗: change from baseline at week 3, relative to control
change in systolic blood pressure
时间窗: change from baseline at week 3, relative to control
次要结局
- change in total cholesterol(change from baseline at week 3, relative to control)
- change in LDL cholesterol(change from baseline at week 3, relative to control)
- change in HDL cholesterol(change from baseline at week 3, relative to control)
- change in apolipoprotein A-1(change from baseline at week 3, relative to control)
- change in apolipoprotain B(change from baseline at week 3, relative to control)
- change in glucose(change from baseline at week 3, relative to control)
- change in insulin(change from baseline at week 3, relative to control)
- diastolic blood pressure(change from baseline at week 3, relative to control)
- change in body weight(change from baseline at week 3, relative to control)
- change in apoB:ApoA-1(change from baseline at week 3, relative to control)
研究者
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