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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by InQpharm Group
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01905956
First received: July 19, 2013
Last updated: October 6, 2013
Last verified: October 2013
  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 glucomannan, kappa-carrageenan and xanthan gum, in appetite regulation.


Condition Intervention Phase
Weight Loss
Appetite Management
Device: IQP-AK-102
Device: 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:
  • Difference in the mean change in body weight between the two arms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured in kg using calibrated weighing scales


Secondary Outcome Measures:
  • Waist and hip circumference (cm) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Body fat content and fat free mass [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Food craving questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global evaluation of efficacy by the subjects and investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global evaluation of safety by the subjects and investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IQP-AK-102
2 capsules per dose, three times daily
Device: IQP-AK-102
Placebo Comparator: Placebo
2 capsules per dose, 3 times daily
Device: Placebo

  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 (glucomannan, kappa- carrageenan and xanthan gum)
  • 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 Recruiting
Berlin, Germany, 10709
Contact: Barbara Grube, MD    +49 30/892 1030    bgrube@web.de   
Principal Investigator: Barbara Grube, MD         
Sponsors and Collaborators
InQpharm Group
  More Information

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01905956     History of Changes
Other Study ID Numbers: INQ/010013
Study First Received: July 19, 2013
Last Updated: October 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 27, 2014