NCT02930668已完成不适用
Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo
研究概览
简要总结
It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing weight in the overweight and obese. The present study aims at expanding the data concerning the weight management effect of Glucosanol™ in overweight and moderately obese population.
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, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •BMI 25 kg/m2 - 34,9 kg/m2
- •Generally in good health• Desire to lose weight
- •Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
- •Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)• Readiness to take IP as recommended
- •Readiness to avoid the use of other weight loss and/or management products and/or programs during the study
- •Readiness to adhere to diet recommendation during the study
- •Readiness to keep the habitual level of physical activity as prior to the study during the study
- •Readiness and ability to complete the subject diary and study questionnaires
- •Negative pregnancy testing (beta HCG-test in urine) at V1 in women of childbearing potential
- •Women of childbearing potential: commitment to use contraception methods
排除标准
- •Known allergy or hypersensitivity to the components of the investigational products
- •Known allergy or hypersensitivity to members of the Fabaceae family
- •Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
- •Significant disorders:
- •untreated or unstable thyroid gland disorder
- •untreated or unstable hypertension (>140/90 mm Hg)
- •acute or chronic gastrointestinal (GI) disease or malabsorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- •diabetes mellitus- coagulation disorder- any other serious organ or systemic diseases that could influence the conduct and/or out-come of the study and/or could affect the tolerability of the subject (in the opinion of the investigator)
- •Significant surgery within the last 6 months prior to V1:
- •GI surgery
- •liposuction
- •History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to V1
- •Clinically relevant excursions of safety laboratoryparameters
- •Any electronic medical implant
- •Regular use of anticoagulants
- •Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:
- •that could influence body weight (e.g. systemic corticosteroids)
- •that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, anti-diarrheals etc.) as per investigator judgement
- •for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)
- •Consumption of food supplements or natural health products for the duration of the study
- •Diet to lose and/or manage weight (except ac-cording to the study protocol)
- •Vegetarian, vegan or macrobiotic diet
- •Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
- •Pregnancy or nursing
- •History of or current abuse of drugs, alcohol or medication
- •Inability to comply with study requirements
- •Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
- •Participation in another clinical study in the 30 days prior to V1 and during the study
结局指标
主要结局
Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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