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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 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
研究组 & 干预措施
Placebo
Placebo Comparator
The placebo is identical in shape, colour and size to the active comparator with the active ingredient replaced with microcrystalline cellulose.
Subjects will take 2 capsules three times a day, 30 mins before meals.
干预措施: Placebo (Dietary Supplement)
Low dose (Glucosanol 350mg)
Experimental
Each capsule contains Glucosanol / Phaselite 350mg
Subjects will take 2 capsules three times a day, 30 mins before meals.
干预措施: Glucosanol 350mg (Dietary Supplement)
High dose (Glucosanol 500mg)
Experimental
Each capsule contains Glucosanol / Phaselite 500mg
Subjects will take 2 capsules three times a day, 30 mins before meals.
干预措施: Glucosanol 500mg (Dietary Supplement)
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 (1)
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