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

NCT ID: NCT01681069

Last Updated: 2015-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IQP-VV-102

2 tablets twice a day

Group Type ACTIVE_COMPARATOR

IQP-VV-102

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 tablets twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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IQP-VV-102

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InQpharm Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Grube, MD

Role: PRINCIPAL_INVESTIGATOR

Practice for General Medicine

Locations

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Barbara Grube

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26074990 (View on PubMed)

Other Identifiers

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INQ/009712

Identifier Type: -

Identifier Source: org_study_id

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