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

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ClinicalTrials.gov Identifier: NCT01681069
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 7, 2012
Results First Submitted Date  ICMJE September 1, 2015
Results First Posted Date  ICMJE November 6, 2015
Last Update Posted Date November 6, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Change in Body Weight at End of Study Compared to Baseline [ Time Frame: 12 weeks ]
Change in body weight at the end of study compared to baseline
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
Difference in mean loss of body weight [ Time Frame: 12 weeks ]
Measured in kg using calibrated weighing scales
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • Change in Waist Circumference (in cm) at End of Study From Baseline [ Time Frame: 12 weeks ]
    Difference in waist circumference (in cm) at end of study from baseline
  • Change in Mean Body Fat at End of Study From Baseline [ Time Frame: 12 weeks ]
    Measured in kg using calibrated weighing scales
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • Difference in mean loss of body fat [ Time Frame: 12 weeks ]
    Measured in kg using calibrated weighing scales
  • Waist circumference [ Time Frame: 12 weeks ]
    Measured in cm
  • Clinical lab measurements [ Time Frame: 12 weeks ]
    Full blood count and clinical chemistry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of IQP-VV-102 in Weight Management
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
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
  • Obesity
  • Overweight
Intervention  ICMJE
  • Dietary Supplement: IQP-VV-102
  • Other: Placebo
Study Arms  ICMJE
  • Active Comparator: IQP-VV-102
    2 tablets twice a day
    Intervention: Dietary Supplement: IQP-VV-102
  • Placebo Comparator: Placebo
    2 tablets twice a day
    Intervention: Other: Placebo
Publications * Grube B, Bongartz U, Alt F. IQP-VV-102, a Novel Proprietary Composition for Weight Reduction: A Double-Blind Randomized Clinical Trial for Evaluation of Efficacy and Safety. Evid Based Complement Alternat Med. 2015;2015:413075. doi: 10.1155/2015/413075. Epub 2015 May 17. Erratum in: Evid Based Complement Alternat Med. 2016;2016:7173896.

*   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: September 6, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01681069
Other Study ID Numbers  ICMJE INQ/009712
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InQpharm Group
Study Sponsor  ICMJE InQpharm Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Grube, MD Practice for General Medicine
PRS Account InQpharm Group
Verification Date October 2015

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