Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease. Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and blood collected at weeks 0 and 16.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have Metabolic Syndrome as defined by International Diabetes Federation
- •must be able to swallow tablets and capsules
- •must be 18 years of age or older
- •must be physically capable of moderate intensity exercise
排除标准
- •pregnant or lactating
- •vegetarian
研究组 & 干预措施
diet only
low glycemic index diet, calorie restricted with exercise 3 times per week.
干预措施: low glycemic diet (Other)
supplemented
2000 IU vitamin D3 plus 1.8 g EPA + DHA
干预措施: low glycemic diet (Other)
supplemented
2000 IU vitamin D3 plus 1.8 g EPA + DHA
干预措施: vitamin D omega-3 (Dietary Supplement)
结局指标
主要结局
body weight
时间窗: up to 16 weeks
body weight will be measured to nearest 0.5 kg weekly
次要结局
- Blood pressure(up to 16 weeks)
- Blood lipids(up to 16 weeks)
- Glucose homeostasis(up to 16 weeks)
研究者
Kelly Anne Meckling, PhD
Professor
University of Guelph