Diet, Obesity and Genes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- For adults: body weight loss maintenance
研究概览
简要总结
Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.
详细描述
DiOGenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different European countries, testing the efficacy and safety of diets differing in Glycaemic Index (GI) and protein content.
The 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below):
The 2 Shop Centers (Denmark & The Netherlands):
Dietary periods and clinical examinations:
- Clinical examination 1 with anthropometry, blood etc.
- 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only)
- Clinical examination 2 with anthropometry, blood etc.
- 6 months dietary intervention period 1 (SUPERMARKET period)(Family)
- Clinical examination 3 with anthropometry, blood etc.
- 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family).
- Clinical examination 4 with anthropometry, blood ect.
- 12 months free-living period with no dietary intervention. (Family)
- Follow up (only body weight registration)
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
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Families with healthy adults and children
排除标准
- 未提供
研究组 & 干预措施
1
Low Protein, Low GI Diet
干预措施: High or low Glycemic Index and high or low Protein Diet (Behavioral)
2
Low Protein, High Glycemic Index Diet
干预措施: High or low Glycemic Index and high or low Protein Diet (Behavioral)
3
High Protein, Low Glycemic Index diet
干预措施: High or low Glycemic Index and high or low Protein Diet (Behavioral)
4
High Protein, High glycemic index diet
干预措施: High or low Glycemic Index and high or low Protein Diet (Behavioral)
5
Control diet (current recommendations)
干预措施: High or low Glycemic Index and high or low Protein Diet (Behavioral)
结局指标
主要结局
For adults: body weight loss maintenance
时间窗: 6 Month
The primary outcome is related to body weight loss maintenance after 6 month of intensive, homogeneous and therefore comparable dietary intervention across all 8 centres.
次要结局
- For adults: More than 10% weight loss maintenance(6 month)
- For adults: Drop out rate(6 month)
- For Children: Change in BMI-Z-score(6 month)
- For Adults: Change in risk factors for type-2 diabetes(6 month)
- For Adults: Change in risk factors for cardiovascular disease(6 month)
- For adults: change in body composition(6 Month)
- For adults: More than 5% weight loss maintenance(6 month)
- For children: Change in body weight(6 month)
研究者
Arne Astrup
Head of Department
University of Copenhagen