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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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

Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: IQP-VV-102 Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Change in Mean Body Fat at End of Study From Baseline [ Time Frame: 12 weeks ]
    Measured in kg using calibrated weighing scales


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681069


Locations
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Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
Investigators
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Principal Investigator: Barbara Grube, MD Practice for General Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01681069    
Other Study ID Numbers: INQ/009712
First Posted: September 7, 2012    Key Record Dates
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Overweight
Body Weight