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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681069
First Posted: September 7, 2012
Last Update Posted: November 6, 2015
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.
Information provided by (Responsible Party):
InQpharm Group
  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
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

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • 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:
  • 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


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Barbara Grube, MD Practice for General Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01681069     History of Changes
Other Study ID Numbers: INQ/009712
First Submitted: September 4, 2012
First Posted: September 7, 2012
Results First Submitted: September 1, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms