NCT02529631已完成不适用
Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
研究概览
简要总结
This trial compares two treatment methods:
- Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet.
- Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 28 kg/m² and < 45 kg/m²
- •Waist circumference > 80 cm (women) > 94 cm (men)
排除标准
- •Energy intake lower than the standard value according to Miffin St-Jeor equation
- •Pregnancy or breast-feeding
- •Addiction to alcohol
- •Inability to fulfil the requirement of the trial protocol
- •Cancer ,malignant tumour
- •Hypersensitivity reactions to crustaceans or ingredient of the study medication
- •Chronic diseases not under control with adequate therapy
研究组 & 干预措施
Drug: orlistat 60mg capsules
Active Comparator
A tailored blister-strip for one day contains
- three capsules with orlistat 60mg Administration: 3 times daily 1 capsule with each meal containing fat concomitant with
- six placebo tablets Administration: 3 times daily 2 tablets with each main meal
干预措施: orlistat 60 mg (Drug)
Medical device: polyglucosamine
Active Comparator
A tailored blister-strip for one day contains
- three placebo capsules Administration: 3 times daily 1 capsule with each meal containing fat concomitant with
- six tablets Administration: 3 times daily 2 tablets (whereas the 2 tablets in the mold "breakfast" are placebo tablets and the remaining 4 tablets for lunch and dinner contains poliglucosamine
干预措施: polyglucosamine (Device)
结局指标
主要结局
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
时间窗: 12 weeks
次要结局
- BMI reduction(12 weeks)
- Waist circumference reduction(12 weeks)
研究者
研究点 (2)
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