Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insulin Resistance
研究概览
简要总结
The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women diagnosed with carbohydrate metabolism disorder,
- •obesity (BMI >29,9 kg/m2)
- •patients not participating in other similar research programs at the same time,
- •written agreement to take part in the research.
排除标准
- •the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
- •failure to comply with dietary recommendations established during the nutritional intervention,
- •pregnancy and breast feeding.
研究组 & 干预措施
NAC group
NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder
干预措施: NAC group (Dietary Supplement)
Control group
Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Insulin Resistance
时间窗: 12 weeks
Fasting insulin concentration (uU/ml) will be measured before and after 2 hours of 75g glucose drink. Insulin resistance will be measured before and after 12 weeks of the intervention.
Oral glucose toletance test OGTT
时间窗: 12 weeks
Fasting glucose concentration (mg/dL) will be measured before and after 2 hours of 75g glucose drink. OGTT test will be measured before and after 12 weeks of the intervention. Fasting glucose and fasting insulin concentrations will be combined to report HOMA-IR index (homeostatic model assessment of insulin resistance).
次要结局
- Glutathione level uM/L(12 weeks)
- Cytokine measured(12 weeks)
- Homocysteine concentrations mg/dL(12 weeks)
- Body weight kg(12 weeks)
- Body height kg(baseline)
- MTHFR polymorphism(baseline)
- Blood lipoproteins measured.(12 weeks)
- Body mass index kg/m2(12 weeks)
- Body composition(12 weeks)
- C-Reactive Protein measured(12 weeks)
研究者
Agata Chmurzyńska
dr hab, Director of Institute of Human Nutrition and Dietetics
Poznan University of Life Sciences