NCT03227276已完成不适用
Double-blind, Randomised, Placebo-controlled 1-year Study to Evaluate the Efficacy and Safety of Litramine 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
- 166
- 试验地点
- 1
- 主要终点
- Difference in mean body weight (kg) of overweight subjects
研究概览
简要总结
To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 18 to 70 years old
- •Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI 30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects
- •Generally in good health
- •Desire to lose weight
- •Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview
- •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)
- •Subject's agreement to comply with study procedures, in particular:
- •to take IP as recommended
- •to avoid the use of other weight loss and/or management products and/or programs during the study
- •to adhere to diet recommendation during the study
- •to complete the subject diary and study questionnaires
- •Women of childbearing potential:
- •commitment to use contraception methods
- •negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •Written informed consent
排除标准
- •Known allergy or hypersensitivity to the components of the investigational products or source plants
- •Pathological electrocardiogram (ECG) at V1
- •History and/or presence of clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- •untreated or unstable thyroid gland disorder
- •untreated or unstable hypertension (regular blood pressure >140/90 mm Hg)
- •acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g.
- •inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- •diabetes mellitus type 1
- •untreated or unstable diabetes mellitus type 2
- •any other serious organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
- •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 months prior to V1
- •Deviation of safety laboratory parameter(s) at V1 that is:
- •clinically significant or
- •>2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- •Any electronic medical implant
- •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. laxatives, opioids, anticholinergics etc.) as per investigator judgement
- •for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)
- •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)
- •Women of child-bearing potential: pregnancy or nursing
- •History of or current abuse of drugs, alcohol or medication
- •Participation in another clinical study in the 30 days prior to V1 and during the study
- •Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo tablet (Dietary Supplement)
Litramine
Experimental
干预措施: Litramine (Dietary Supplement)
结局指标
主要结局
Difference in mean body weight (kg) of overweight subjects
时间窗: 52 weeks
Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo
次要结局
- Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight(52 weeks)
- Difference in mean body weight (kg) of all subjects(52 weeks)
- Difference in mean body weight (kg) of obese subjects(52 weeks)
研究者
研究点 (1)
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