Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
研究概览
简要总结
The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.
详细描述
Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.
One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI >30 and < 35
- •waist circumference of more than 88 cm for women and greater than 102 for men
排除标准
- •pregnancy or breast-feeding
- •alcohol abuse
- •drug abuse or drug addiction
- •inability to fulfill the criteria of the trial protocol
- •cancer diseases
- •malignant tumors
- •pre-existence of chronic intestinal disease
- •known hypersensitivity reactions to crustaceans
研究组 & 干预措施
Medical device polyglucosamine
2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity
干预措施: polygucosamine (Device)
Placebo
2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity
干预措施: placebo (Other)
结局指标
主要结局
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
时间窗: 12 months
次要结局
- Change of body weight in kg(12 months)
- Change of BMI(12 monts)
- Reduction of waist circumference(12 months)