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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905956
• Other study ID #: INQ/010013
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2013
• Last updated: February 10, 2016
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Dietary Supplement:
• IQP-AK-102
IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.
• Placebo
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.

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Global Evaluation of Efficacy by the Investigators		12 weeks	No
Secondary	Global Evaluation of Efficacy by the Subjects		12 weeks	No
Secondary	Global Evaluation of Safety by the Investigators		12 weeks	Yes
Secondary	Global Evaluation of Safety by the Subjects		12 weeks	Yes