Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink supplement on development in body weight and body composition, and risk markers for type-2 diabetes and cardiovascular disease in obese subjects.
详细描述
The study consists of a parallel RCT with 96 overweight/obese subjects enrolled into two treatment arms: placebo or active for 12 weeks. They will undergo examination at time points 0 and 12 weeks where a DXA scan will be performed to assess body composition and a fasting blood sample will be taken. At time points 0, 2, 4, 6, 8, 10 and 12 weeks their weight and waist circumference and number of test products not consumed will be recorded. In addition all subjects receive dietary counselling during the 12 weeks.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Overweight to obese (BMI 28-45 kg/m2)
排除标准
- •Chronic diseases including:liver and kidney disease, including P-Alanine aminotransferase (ALT), P-aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatinine kinase and P-lactate dehydrogenase (LD)> 2.0 times the upper limit of normal (ULN) (measured at the screening at the Department of Human Nutrition)
- •systemic infections and metabolic diseases that can interfere with energy balance,
- •diabetes or fasting blood glucose concentration> 7.0 mM, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmHg, hyperlipidemia (total cholesterol> 6.5 mM and triglycerides> 5.0 mM) (measured by the screening at the Department of Human Nutrition)
- •Food allergies
- •Psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment
- •Use of dietary supplements (during the experimental period and 3 months before study start)
- •Provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin <7.5 mmol / l (measured at the screening at the Department of Human Nutrition)
- •Smoking (throughout the trial and 6 months before study start)
- •Elite Athletes (> 10 hours strenuous exercise per week, self-reported)
- •Women who are pregnant or breastfeeding, and post-menustruelle (self reported)
结局指标
主要结局
Body weight
时间窗: 12 Weeks
次要结局
- Risk markers for type 2 diabetes(12 weeks)
- Blood pressure(12 weeks)
- Risk markers for cardiovascular disease(12 Weeks)
- Body composition(12 Weeks)