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

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ClinicalTrials.gov Identifier: NCT01905956
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Tracking Information
First Submitted Date  ICMJE July 19, 2013
First Posted Date  ICMJE July 23, 2013
Results First Submitted Date  ICMJE January 4, 2016
Results First Posted Date  ICMJE March 8, 2016
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
Mean Change in Body Weight From Baseline to Week 12 [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
Difference in the mean change in body weight between the two arms [ Time Frame: 12 weeks ]
Measured in kg using calibrated weighing scales
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 [ Time Frame: 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).
  • Mean Change in Body Fat Content (%) From Baseline to Week 12 [ Time Frame: 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).
  • Mean Change in Body Fat Mass (kg) From Baseline to Week 12 [ Time Frame: 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).
  • Food Craving Questionnaire (FCQ) [ Time Frame: 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.
  • Global Evaluation of Efficacy by the Investigators [ Time Frame: 12 weeks ]
  • Global Evaluation of Efficacy by the Subjects [ Time Frame: 12 weeks ]
  • Global Evaluation of Safety by the Investigators [ Time Frame: 12 weeks ]
  • Global Evaluation of Safety by the Subjects [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
  • Waist and hip circumference (cm) [ Time Frame: 12 weeks ]
    Changes from baseline to end of study
  • Body fat content and fat free mass [ Time Frame: 12 weeks ]
    Changes from baseline to end of study
  • Food craving questionnaire [ Time Frame: 12 weeks ]
  • Global evaluation of efficacy by the subjects and investigators [ Time Frame: 12 weeks ]
  • Global evaluation of safety by the subjects and investigators [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: IQP-AK-102
    2 capsules per dose, three times daily
    Intervention: Dietary Supplement: IQP-AK-102
  • Placebo Comparator: Placebo
    2 capsules per dose, 3 times daily
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2015)
119
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2013)
120
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01905956
Other Study ID Numbers  ICMJE INQ/010013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InQpharm Group
Study Sponsor  ICMJE InQpharm Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Udo Bongartz analyze & realize GmbH
PRS Account InQpharm Group
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP