Safety and Efficacy of IQP- AK-102 in Reducing Body Weight

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: IQP-AK-102
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IQP-AK-102<br>2 capsules per dose, three times daily | Dietary Supplement: IQP-AK-102<br>* IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.<br>|
| Placebo Comparator: Placebo<br>2 capsules per dose, 3 times daily | Dietary Supplement: Placebo<br>* The placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Body Weight From Baseline to Week 12 | 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). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest. Hip circumference (cm) was measured as the maximal circumference over the buttocks. Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values). | Baseline and 12 weeks | 
| Mean Change in Body Fat Content (%) From Baseline to Week 12 | Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values). | Baseline and 12 weeks | 
| Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values). | Baseline and 12 weeks | 
| Food Craving Questionnaire (FCQ) | This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale: = I do not agree at all = I do not agree = Neutral = I agree = I highly agree Results were expressed as the mean score for the whole population in the respective intervention group. | Baseline and 4, 8, and 12 weeks | 
| Global Evaluation of Efficacy by the Investigators |  | 12 weeks | 
| Global Evaluation of Efficacy by the Subjects |  | 12 weeks | 
| Global Evaluation of Safety by the Investigators |  | 12 weeks | 
| Global Evaluation of Safety by the Subjects |  | 12 weeks |