NCT03058367已完成不适用
Double-blind, Randomised, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 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
- 108
- 试验地点
- 1
- 主要终点
- Mean change in body weight (kg)
研究概览
简要总结
This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg daily) in reducing body weight 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years
- •Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)
- •Expressed desire for weight loss
- •Accustomed to 3 main meals/day
- •Commitment to take IP as recommended
- •Commitment to adhere to diet recommendation during the study
- •Commitment to maintain habitual level of activity/exercise during the study
- •Consistent and stable body weight for 3 months prior to V1
- •Commitment to avoid the use of other weight management products or programs during study
- •Commitment and ability to complete the subject diary and study questionnaires
- •Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period
- •Consents to participate, understands requirements of the study and is willing to comply
排除标准
- •Known sensitivity to the ingredients of the investigational product or source of ingredients
- •Pregnancy or nursing
- •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)
- •Current or history of abuse of drugs, alcohol or medication
- •Clinically relevant excursions of safety laboratory parameter
- •Diabetes mellitus type 1
- •Untreated or unstable diabetes mellitus type 2
- •Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
- •Stenosis in the gastrointestinal (GI) tract
- •Bariatric surgery in subject´s medical history
- •Abdominal surgery within the last 6 months prior to V1
- •Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.)
- •Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis)
- •Digestion/absorption disorders in gastrointestinal (GI) tract
- •History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1
- •Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1
- •Any electronic medical implant
- •Use of any medication that could influence GI functions such as antibiotics within 4 weeks and any laxatives, opioids, glucocorticoids, anticholinergics within last 3 months prior to V1 and during the study, as per investigator judgement
- •Any medication or use of products for the treatment of obesity (e.g. orlistat, other fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.) within last 3 months prior to V1 and during the study
- •Participation in similar studies or weight loss programs within last 4 weeks prior to V1
- •Participation in other studies during the last 4 weeks prior to V1
- •Inability to comply
- •Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement
研究组 & 干预措施
High dose IQP-AE-103 (1980mg)
Experimental
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
干预措施: IQP-AE-103 (330mg) (Dietary Supplement)
Low dose IQP-AE-103 (990mg)
Experimental
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
干预措施: IQP-AE-103 (165mg) (Dietary Supplement)
Placebo
Placebo Comparator
2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Mean change in body weight (kg)
时间窗: 12 weeks
Difference in mean change of body weight (kg) between the higher dosed verum (1980 mg a day) and placebo group after 12 weeks of intervention in comparison to baseline.
次要结局
- Mean change in body weight (kg)(2, 4, 8, 12 weeks)
- Mean change in body weight (%)(2, 4, 8, 12 weeks)
- Proportion of subject weight loss(2, 4, 8, 12 weeks)
- Change in waist circumference (cm)(2, 4, 8, 12 weeks)
- Change in hip circumference (cm)(2, 4, 8, 12 weeks)
研究者
研究点 (1)
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