Completed
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
What is being tested
IQP-VV-102
+ Placebo
Dietary SupplementOther
Who is being recruted
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
From 18 to 60 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
Summary
Principal SponsorInQpharm Group
Last updated: November 6, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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
Principal SponsorInQpharm Group
Last updated: November 6, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionObesityOverweight
Criteria
3 inclusion criteria required to participate
25 kg/m2 <= BMI <= 35 kg/m2
Age 18 to 60 years
Written informed consent
4 exclusion criteria prevent from participating
Inability to comply with study requirements, e.g. due to language difficulties
Known sensitivity to sources of the active ingredients and excipients
Participation in another study during the last 30 days of the screening visit
Pregnancy or nursing
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active Comparator2 tablets twice a day
Group II
Placebo2 tablets twice a day
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center