NCT01193543已完成2 期
Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Intra-abdominal fat as measured with CT scan
研究概览
简要总结
Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 25-30 kg/m2
- •age 20-65 years
排除标准
- •coronary heart disease last 12 months
- •unstable angina pectoris
- •cancer diagnosed the last 5 years
- •use of lipid lowering drugs
- •seafood allergy
结局指标
主要结局
Intra-abdominal fat as measured with CT scan
时间窗: at the end of 12 months intervention
次要结局
- oral glucose tolerance test(at the end of 12 months intervention)
- lipid status(at the end of 12 months intervention)
- systolic and diastolic blood pressure(at the end of 12 months intervention)
- markers of inflammation - C-reactive protein (CRP)(at the end of 12 months intervention)
- body weight(at the end of 12 months intervention)
研究者
研究点 (2)
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