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

Phase 3

Completed

Conditions: Weight Loss

Interventions: Dietary Supplement: IQP-AK-102
Dietary Supplement: Placebo

Registration Number: NCT01905956

Lead Sponsor: InQpharm Group

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 119

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IQP-AK-102	IQP-AK-102	2 capsules per dose, three times daily
Placebo	Placebo	2 capsules per dose, 3 times daily

Primary Outcome Measures

Name	Time	Method
Mean Change in Body Weight From Baseline to Week 12	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).

Secondary Outcome Measures

Name	Time	Method
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	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).
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	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).
Mean Change in Body Fat Content (%) From Baseline to Week 12	Baseline and 12 weeks	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).
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	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: 1. = I do not agree at all 2. = I do not agree 3. = Neutral 4. = I agree 5. = I highly agree Results were expressed as the mean score for the whole population in the respective intervention group.