Clinical trial NCT01905956: Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Body Weight From Baseline to Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Mean Change in Body Fat Content (%) From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Mean Change in Body Fat Mass (kg) From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Food Craving Questionnaire (FCQ)
timeFrame: Baseline and 4, 8, and 12 weeks
measure: Global Evaluation of Efficacy by the Investigators
timeFrame: 12 weeks
measure: Global Evaluation of Efficacy by the Subjects
timeFrame: 12 weeks
measure: Global Evaluation of Safety by the Investigators
timeFrame: 12 weeks
measure: Global Evaluation of Safety by the Subjects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube
Study officials:
affiliation: analyze & realize GmbH
name: Udo Bongartz
role: PRINCIPAL_INVESTIGATOR
References: