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

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

IQP-VV-102

Placebo

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Barbara Grube

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IQP-VV-102

Placebo

Arm Description

2 tablets twice a day

Outcomes

Primary Outcome Measures

Change in Body Weight at End of Study Compared to Baseline

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

Difference in waist circumference (in cm) at end of study from baseline

Change in Mean Body Fat at End of Study From Baseline

Measured in kg using calibrated weighing scales

Full Information

NCT ID

NCT01681069

First Posted

September 4, 2012

Last Updated

October 5, 2015

Sponsor

InQpharm Group

1. Study Identification

Unique Protocol Identification Number

NCT01681069

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InQpharm Group

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IQP-VV-102

Arm Type

Active Comparator

Arm Description

2 tablets twice a day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 tablets twice a day

Intervention Type

Dietary Supplement

Intervention Name(s)

IQP-VV-102

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in Body Weight at End of Study Compared to Baseline

Description

Change in body weight at the end of study compared to baseline

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Waist Circumference (in cm) at End of Study From Baseline

Description

Difference in waist circumference (in cm) at end of study from baseline

Time Frame

12 weeks

Title

Change in Mean Body Fat at End of Study From Baseline

Description

Measured in kg using calibrated weighing scales

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Grube, MD

Organizational Affiliation

Practice for General Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barbara Grube

City

Berlin

ZIP/Postal Code

10709

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26074990

Citation

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.

Results Reference

derived

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

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