Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of IQP- AK-102 in Reducing Body Weight in Overweight and Obese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Mean Change in Body Weight From Baseline to Week 12
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.
详细描述
Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by biological, behavioral and environmental stimuli. Satiation (intrameal satiety) is defined as the process of feeling full and subsequently stopping food consumption during eating, it therefore reduces hunger and limits the energy consumptions during meals. On the other hand, satiety or more precisely intermeal satiety, delays the onset and possibly reduces the consumption of the next meal. High viscosity and bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than macronutrients or clear liquid.
Due to its unique physicochemical properties, dietary fibre has been recognized as a 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, and eventually leading on to weight loss.
The investigational product is formulated from IQP-AK-102, a proprietary, patent pending combination of three soluble fibres. In-vitro studies showed synergistic properties for the fibres in IQP-AK-102. When consumed orally, IQP-AK-102 capsules dissolve in the stomach to release the fibres. Once hydrated, the fibres swell to form a thick, viscous and indigestible gel structure in the stomach. This physical structure results in increased gastric distension and delays the gastric emptying that induces satiety and fullness.
However the unique composition of IQP-AK-102 had not been evaluated in human clinical studies. The objective of this placebo controlled, double blind study was to confirm the benefit of IQP-AK-102 in weight loss through promoting satiety and managing appetite. In this study, 120 overweight and obese subjects (60 per study arm) were tested to investigate if IQP-AK-102 is effective in reducing body weight over a period of 12 weeks.
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
结局指标
主要结局
Mean Change in Body Weight From Baseline to Week 12
时间窗: Baseline and 12 weeks
Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values).
次要结局
- Global Evaluation of Efficacy by the Investigators(12 weeks)
- Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12(Baseline and 12 weeks)
- Global Evaluation of Efficacy by the Subjects(12 weeks)
- Mean Change in Body Fat Mass (kg) From Baseline to Week 12(Baseline and 12 weeks)
- Mean Change in Body Fat Content (%) From Baseline to Week 12(Baseline and 12 weeks)
- Global Evaluation of Safety by the Investigators(12 weeks)
- Global Evaluation of Safety by the Subjects(12 weeks)
- Food Craving Questionnaire (FCQ)(Baseline and 4, 8, and 12 weeks)