Office of Human Research, Taipei Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Body Weight
研究概览
简要总结
Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat concentration, and weight management, and has other health benefits.The purposes of this study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and diabetic patients.
详细描述
The KGN diet was composed of well-cooked noodle with 2 g of KGM in a dosage of 200 g/piece twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period between alternative diets. All 33 subjects received two servings of either GMNs or PNs (400 g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. After a 2-week washout period, the subjects received the other type of noodle for 4 weeks. The body weight, BMI, waist circumference, fasting blood glucose and lipid profile, as well as serum vitamin A, E, β-carotene and high sensitivity C-reactive protein (hs-CPR) were measured by HPCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with metabolic syndrome
- •Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:
- •Abdominal obesity (waist circumference >= 90 cm in men and >= 80 cm in women)
- •Impaired fasting glucose ( >= 5.6 mmol/L)
- •Hypertriglyceridemia ( >= 1.7 mmol/L)
- •Low HDL-C (< 1.0 mmol/L in men and < 1.3 mmol/L in women)
- •Increased blood pressure (SBP >= 130 mmHg and DBP >= 85 mmHg).
排除标准
- •Liver and renal diseases
- •Undergoing statin therapy
- •Pregnancy women
- •Taking antioxidant vitamins supplements
研究组 & 干预措施
GMN Diet
In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
干预措施: Glucomannan noodle (Dietary Supplement)
GMN Diet
In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
干预措施: Placebo noodle (Dietary Supplement)
PN Diet
In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
干预措施: Glucomannan noodle (Dietary Supplement)
PN Diet
In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
干预措施: Placebo noodle (Dietary Supplement)
结局指标
主要结局
Body Weight
时间窗: 4 weeks
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
次要结局
- Waist Circumference(4 weeks)
- Glycemic Index(4 weeks)
- Lipid Index(4 weeks)