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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01681069
First received: September 4, 2012
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated 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
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: May 22, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013