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

Phase 3

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: IQP-VV-102; Other: Placebo

• Registration Number: NCT01681069
• Lead Sponsor: InQpharm Group

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 available

Study Timeline

• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Study Start: 2012-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-09-01
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-05
• Last Update Submitted: 2015-10-05
• Results First Posted: 2015-11-06
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IQP-VV-102	IQP-VV-102	2 tablets twice a day
Placebo	Placebo	2 tablets twice a day

Primary Outcome Measures

Name	Time	Method
Change in Body Weight at End of Study Compared to Baseline	12 weeks	Change in body weight at the end of study compared to baseline

Secondary Outcome Measures

Name	Time	Method
Change in Waist Circumference (in cm) at End of Study From Baseline	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	12 weeks	Measured in kg using calibrated weighing scales

Trial Locations

Locations (1)

Barbara Grube; 🇩🇪 Berlin, Germany