NCT00655902已完成不适用
Copenhagen Obesity Risk Assessment Study - A Double Blind Randomized Dietary Intervention Study Examining the Effect of a High Intake of Trans Fatty Acids on Abdominal Obesity and Risk Markers of Type 2 Diabetes and Cardiovascular Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- change in LDL-cholesterol/LDL-cholesterol ratio
研究概览
简要总结
The aim of the present study is to assess the effect of a high intake of industrially produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2 diabetes and heart disease in healthy, moderately overweight, postmenopausal women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 45-70 years
- •BMI 25-32
- •Waist circumference > 80 cm
- •Postmenopausal for at least 1 year
排除标准
- •BP > 160/100 mmHg
- •Fasted blood glucose > 7 mM
- •Fasted LDL-cholesterol > 6 mM
- •Fasted triglycerides > 3 mM
- •Diabetes mellitus or other chronic diseases
- •Current or previous cardiovascular disease
- •Weight change > 3 kg within last 2 months
- •Use of anti-hypertensive drugs
- •Use of statins/fibrates
- •Use of fish oil supplements
- •Hard physical activity > 10 h/week
结局指标
主要结局
change in LDL-cholesterol/LDL-cholesterol ratio
时间窗: week 0, 8, 16 and 28
Change in Liver fat measured by MR-S
时间窗: week 0, 16 and 28
Change in Insulin sensitivity (ISI composite) from 3h OGTT
时间窗: week 0, 8, 16 and 28
次要结局
- Change in Waist circumference(week 0, 8, 16 and 28)
- Change in Visceral adipose tissue measured by MR(week 0, 16 and 28)
- Change in Intramuscular fat measured by MR-S (Psoas Major)(week 0, 16 and 28)
- Change in Body fat percentage measured by DEXA(week 0, 16 and 28)
- Change in 24h heart rate variability measured by Holter-monitoring(week 0, 16 and 28)
- Changes in Cytokines in blood(week 0, 8, 16 and 28)
- Changes in Cytokines in abdominal adipose tissue(week 0, 16 and 28)
- Changes in Ceramide in abdominal adipose tissue(week 0, 16 and 28)
- Changes in Metabolomic profile in blood and urine(week 0, 16 and 28)
研究者
研究点 (2)
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