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

InQpharm

Status and phase: Completed; Phase 3

Conditions: Weight Loss

Treatments: Dietary Supplement: Placebo; Dietary Supplement: IQP-AK-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01905956

INQ/010013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 2 patient groups, including a placebo group

IQP-AK-102

Active Comparator group

Description:

2 capsules per dose, three times daily

Treatment:

Dietary Supplement: IQP-AK-102

Placebo

Placebo Comparator group

Description:

2 capsules per dose, 3 times daily

Treatment:

Dietary Supplement: Placebo