Open-Label Clinical Investigation to Evaluate Efficacy and Safety of IQP-AK-102 on Appetite Reduction in Healthy Over- Weight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in appetite before and after breakfast 3 days a week (including one weekend day) using Haber Score (hunger, satiety)
研究概览
简要总结
The primary cause of being overweight is an imbalance in calories consumed and energy expenditure. A surplus in energy intake might result in body fat deposition and thereby body weight gain. Therefore, food intake regulation is crucial to control the body weight gain.
Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by the individual (physiology and psychology) and environment. Satiation (process that leads to the termination of eating) and satiety (decline in hunger, increase in fullness after a meal has finished) are the precursors of appetite regulation, which may be induced by various food components such as macronutrients, water, alcohol and non-digestible polysaccharides. High viscosity and swellable/bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or clear liquid. Due to its unique physicochemical properties, dietary fibre has been recognized as potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake.
IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102 on appetite reduction in overweight subjects during a 4-weeks interval.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, aged 18-65 years
- •BMI ≥25 and BMI <30 kg/m2
- •Generally in good health
- •Regular daily consumption of 3 main meals (breakfast, lunch, dinner)
- •Consistent regular physical activity (≤4 hours of strenuous sportive activity per week) AND willingness to maintain the same level of sport activity throughout the study
- •Commitment to avoid the use of other weight loss and/or management products / programmes during the study
- •Commitment to complete the subject diary correctly and to adhere to the lifestyle recommended for this study
- •Stable concomitant medications (if any)
- •Stable body weight for the last 3 months prior to V1 (less than 5% self-reported change)
- •Subject's agreement to comply with study procedures
- •Negative pregnancy testing (beta HCG-test in urine) at V1 in females of childbearing potential
- •Women of child-bearing potential: willingness to use reliable method of contraception during the study period
排除标准
- •Known sensitivity to the components of the investigational product
- •Bariatric surgery in the last 12 months prior to V1
- •Abdominal surgery within the last 6 months prior to V1
- •Presence of any active gastrointestinal disease incl. stenosis in the gastrointestinal tract
- •Malabsorption disorders
- •Pancreatitis
- •History of eating disorders like bulimia, anorexia nervosa, binge-eating (within the last 12 months prior to V1)
- •Lack of appetite for any (unknown) reason
- •Use of medications that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, anti-diarrheals 3 months prior to V1 and during the study
- •Use of medications that could influence body weight (e.g. antidepressants) in the last 3 months prior to V1 and during the study
- •Any medication or use of products for the treatment of obesity (e.g. fat binder, fat burner, satiety products etc.) or treatment that could influence food absorption, in last 3 months before V1 and during the study
- •Gluten allergy
- •History of abuse of drugs, alcohol or medication
- •Exceeding moderate alcohol consumption (≥21 units /week; 1 unit is equal 1⁄2 l of beer, or 200 ml of wine, or 50 ml hard liquor)
- •Smoking cessation within 6 months prior to V1 or during the study (regular smoking at the same level as prior to the study during the study is not an exclusion criteria)
- •Inability to comply with study procedures (e.g. due to language difficulties etc.)
- •Participation in similar studies or weight loss programs within the last 6 months prior to V1 and during the study
- •Participation in other clinical studies within the last 30 days prior to V1 and during the study
- •Clinically relevant deviations of laboratory values
- •Any other reason deemed suitable for exclusion, per investigator's judgement
研究组 & 干预措施
IQP-AK-102
2 capsules to be taken 3 times daily orally, 30 min before each main meal (breakfast, lunch, dinner) with 250 mL of water
干预措施: IQP-AK-102 (Device)
结局指标
主要结局
Changes in appetite before and after breakfast 3 days a week (including one weekend day) using Haber Score (hunger, satiety)
时间窗: 6 weeks
- Comparison between week 2 and week 3 (first week of the IP intake) as well as comparison between week 2 and week 6 (last week of the IP intake)
Changes in appetite before and after breakfast 3 days a week (including one weekend day) using VAS (hunger, satiety, fullness, prospective food consumption).
时间窗: 6 weeks
- Comparison between week 2 and week 3 (first week of the IP intake) as well as comparison between week 2 and week 6 (last week of the IP intake)
次要结局
- Global evaluation of safety by investigator(6 weeks)
- Global evaluation of efficacy by subjects(6 weeks)
- Changes in body weight using calibrated weighing scales (Tanita BC-420 SMA)(6 weeks)
- Changes in BMI(6 weeks)
- Changes in waist circumference(6 weeks)
- Changes in hip circumference(6 weeks)
- Changes in body fat content using validated electronic weighing scales according to the Body composition analyser BC-420MA (a bio-impedance analysis (BIA))(6 weeks)
- Changes in fat-free mass using validated electronic weighing scales according to the Body composition analyser BC-420MA (a bio-impedance analysis (BIA))(6 weeks)
- Global evaluation of efficacy by investigator(6 weeks)
- Pulse rate(6 weeks)
- Changes in food intake using the subject diary(6 weeks)
- Blood pressure(6 weeks)
- Global evaluation of safety by subjects(6 weeks)