Efficacy and Safety of IQP-VV-102 in Weight Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01681069
First received: September 4, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored


Condition Intervention Phase
Obesity
Overweight
Dietary Supplement: IQP-VV-102
Other: 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 the Safety and Efficacy of IQP-VV-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 mean loss of body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured in kg using calibrated weighing scales


Secondary Outcome Measures:
  • Difference in mean loss of body fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured in kg using calibrated weighing scales

  • Waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured in cm

  • Clinical lab measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Full blood count and clinical chemistry


Enrollment: 120
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IQP-VV-102
2 tablets twice a day
Dietary Supplement: IQP-VV-102
Placebo Comparator: Placebo
2 tablets twice a day
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 60 years
  • 25 kg/m2 ≤ BMI ≤ 35 kg/m2
  • Written informed consent

Exclusion Criteria:

  • Known sensitivity to sources of the active ingredients and excipients
  • Pregnancy or nursing
  • Inability to comply with study requirements, e.g. due to language difficulties
  • Participation in another study during the last 30 days of the screening visit
  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: NCT01681069

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

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01681069     History of Changes
Other Study ID Numbers: INQ/009712
Study First Received: September 4, 2012
Last Updated: December 11, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014