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

This study has been completed.
Information provided by (Responsible Party):
InQpharm Group Identifier:
First received: July 19, 2013
Last updated: March 24, 2015
Last verified: March 2015
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
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 ]

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
Device: IQP-AK-102
Placebo Comparator: Placebo
2 capsules per dose, 3 times daily
Device: Placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01905956

Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
  More Information

No publications provided

Responsible Party: InQpharm Group Identifier: NCT01905956     History of Changes
Other Study ID Numbers: INQ/010013 
Study First Received: July 19, 2013
Last Updated: March 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms processed this record on February 04, 2016