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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01905956
First received: July 19, 2013
Last updated: February 10, 2016
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Weight Loss
Dietary Supplement: IQP-AK-102
Dietary Supplement: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Mean Change in Body Weight From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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:
  • Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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).


  • Mean Change in Body Fat Content (%) From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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).


  • Mean Change in Body Fat Mass (kg) From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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).


  • Food Craving Questionnaire (FCQ) [ Time Frame: Baseline and 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Global Evaluation of Efficacy by the Investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Evaluation of Efficacy by the Subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Evaluation of Safety by the Investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Global Evaluation of Safety by the Subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 119
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IQP-AK-102
2 capsules per dose, three times daily
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 Comparator: Placebo
2 capsules per dose, 3 times daily
Dietary Supplement: 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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905956

Locations
Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Udo Bongartz analyze & realize GmbH
  More Information

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01905956     History of Changes
Other Study ID Numbers: INQ/010013 
Study First Received: July 19, 2013
Results First Received: January 4, 2016
Last Updated: February 10, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016