NCT02041754已完成3 期
Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
研究概览
简要总结
The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.
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
- Double (Participant, Investigator)
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
- •25≤BMI≤35
- •Expressed desire for weight loss
- •Accustomed to 3 main meals/day
- •Generally in good health
- •Consistent and stable body weight 3 months prior to study enrolment
- •Consistent regular physical activity
- •Commitment to avoid the use of other weight loss products during study
- •Commitment to adhere to diet and lifestyle recommended for the study
排除标准
- •Known sensitivity to the ingredients of the device
- •Presence of any active gastrointestinal disease
- •Malabsorption disorders
- •Pancreatitis
- •Stenosis in the GI tract
- •Bariatric surgery
- •Any other reason deemed suitable for exclusion, per investigator's judgement
研究组 & 干预措施
IQP-AK-102
Active Comparator
2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
干预措施: IQP-AK-102 (Device)
Placebo
Placebo Comparator
2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
干预措施: Placebo (Device)
结局指标
主要结局
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
时间窗: 4 weeks
Measured using a visual analogue scale (VAS)
次要结局
- Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms(4 weeks)
- Difference in the mean change in body weight between the 2 arms, from baseline to the final visit(4 weeks)
- Changes in waist and hip circumference(4 weeks)
- Changes in body fat content and fat free mass(4 weeks)
- Subjects global feeling of satiety(4 weeks)
- Food Craving Questionnaire(4 weeks)
- Global evaluation of efficacy by the subjects and investigators(4 weeks)
- Global evaluation of safety by the subjects and investigators(4 weeks)
- Difference in ad libitum energy intake between the two arms at baseline visit and at final visit(4 weeks)
- Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit(4 weeks)
研究者
研究点 (1)
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