NCT01435278已完成4 期
Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
- •Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
- •BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
- •Expressed desire for weight maintenance
- •Accustomed to 3 main meals per day
- •Commitment to avoid the use of other weight loss products during study
- •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 the ingredients of the device (Phaseolus vulgaris or members of the Fabaceae family)
- •History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
- •History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
- •Clinically relevant excursions of safety parameter
- •Current use of anti-depressants
- •Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
- •Uncontrolled hypertension (more than 160/110 mm Hg)
- •Stenosis in the GI tract
- •Bariatric surgery
- •Abdominal surgery within the last 6 months prior to enrollment
- •History of eating disorders like bulimia, anorexia nervosa within the past 12 months
- •Other serious organ or systemic diseases such as cancer
- •Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
- •Pregnancy or nursing
- •Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
- •More than 3 hours strenuous sport activity per week
- •History of abuse of drugs, alcohol or medication
- •Smoking cessation within 6 months prior to enrolment
- •Inability to comply due to language difficulties
- •Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
结局指标
主要结局
Body weight
时间窗: 24 weeks
Measured in kg using a calibrated scale
次要结局
- Waist and hip circumference (cm)(24 weeks)
- Body mass index, BMI (kg/m2)(24 weeks)
- Body fat content and fat free mass(24 weeks)
- Effect on appetite, hunger and food cravings(24 weeks)
- Feeling of satiety(24 weeks)
- Evaluation of the efficacy of Glucosanol by the subjects(24 weeks)
- Full blood count(24 weeks)
- Clinical chemistry parameter(24 weeks)
- Blood pressure(24 weeks)
- Global evaluation of the safety of Glucosanol by the subjects(24 weeks)
- Global evaluation of the safety of Glucosanol by the investigators(24 weeks)
- Occurrence of adverse events(24 weeks)
研究者
研究点 (1)
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