NCT03741686已完成2 期
Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome
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 systolic blood pressure
研究概览
简要总结
To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Impaired glucose tolerant
- •Clinical absent of CHD
- •BMI less than 30 kg/m2
- •Presence of full insulin resistance syndrome
- •Reduced HDL cholesterol
- •Elevated serum triglycerides
- •Moderate hypertension
排除标准
- •Regular smoking
- •Regular alcohol consumption
- •Family history of premature coronary heart disease
- •Hypothyroidism
- •Renal, hepatic or gastrointestinal disease
- •Taking medications for hyperglycemia
- •Taking medications for hyperlipidemia
- •Taking medications for hypertension
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 systolic blood pressure
时间窗: change from baseline after 3 weeks, relative to control
change in fructosamine
时间窗: change from baseline after 3 weeks, relative to control
change in total:HDL cholesterol
时间窗: change from baseline after 3 weeks, relative to control
次要结局
- change in total cholesterol(change from baseline after 3 weeks, relative to control)
- change in LDL cholesterol(change from baseline after 3 weeks, relative to control)
- change in glucose(change from baseline after 3 weeks, relative to control)
- change in insulin(change from baseline after 3 weeks, relative to control)
- change in HDL cholesterol(change from baseline after 3 weeks, relative to control)
- change in apolipoprotein A-1(change from baseline after 3 weeks, relative to control)
- change in apolipoprotain B(change from baseline after 3 weeks, relative to control)
- change in diastolic blood pressure(change from baseline after 3 weeks, relative to control)
- change in body weight(change from baseline after 3 weeks, relative to control)
- change in apoB:ApoA-1(change from baseline after 3 weeks, relative to control)
研究者
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