NCT01423617已完成3 期
Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in Mean Body Weight (kg)
研究概览
简要总结
The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects.
This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian males and females, age 18 to 60 years
- •25 kg/m2 ≤ BMI ≤32 kg/m2
- •Expressed desire for weight loss
- •Accustomed to 3 main meals a day
- •Consistent and stable body weight 3 months prior to study enrollment
- •Commitment to avoid the use of other weight loss products/programs during the study
- •Commitment to adhere to diet recommendation
- •Females' agreement to use appropriate birth control methods during the active study period
- •Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
排除标准
- •Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
- •History of diabetes mellitus or other endocrine disorders
- •Fasting blood glucose >7 mmol/L
- •Treatment with systemic corticosteroids within the last 12 months
- •Current use of antidepressants
- •Uncontrolled hypertension (>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator
- •Presence of acute or history of chronic gastrointestinal disease
- •Schizophrenia or other diagnosed psychiatric disorders
- •Any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, HIV)
- •Bariatric surgery
- •Abdominal surgery within the last 6 months
- •History of eating disorders like bulimia, anorexia nervosa
- •Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months
- •Pregnancy or nursing
- •Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks
- •More than 3 hours strenuous sport activity per week
- •History of abuse of drugs, alcohol or medication
- •Smoking cessation within the 6 months prior to this study
- •Incompliance due to language difficulties
- •Participation in another study during the last 4 weeks
- •Clinically relevant excursions of safety parameters
结局指标
主要结局
Change in Mean Body Weight (kg)
时间窗: 12 weeks
Change in mean body weight at week 12 compared to baseline.
Change in Mean Body Fat (kg)
时间窗: 12 weeks
Change in mean body fat at week 12 compared to baseline
次要结局
- Number of Subjects Who Lost at Least 3% of Baseline Body Weight(12 weeks)
- Changes in Hip Circumference(12 weeks)
- Changes in Waist-hip-ratio(12 weeks)
- Global Evaluation of Safety by Investigators(12 weeks)
- Changes in Waist Circumference (cm)(12 weeks)
- Changes in Body Fat Content (%)(12 weeks)
- Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)(12 weeks)
- Subjects' Global Feeling of Satiety(12 weeks)
- Global Evaluation of Efficacy by Subjects(12 weeks)
- Changes in Body Fat Free Mass (kg)(12 weeks)
- Global Evaluation of Safety by Subjects(12 weeks)
研究者
研究点 (1)
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