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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-VV-102 | Active Comparator | 2 tablets twice a day |
|
| Placebo | Placebo Comparator | 2 tablets twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-VV-102 | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight at End of Study Compared to Baseline | Change in body weight at the end of study compared to baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Waist Circumference (in cm) at End of Study From Baseline | Difference in waist circumference (in cm) at end of study from baseline | 12 weeks |
| Change in Mean Body Fat at End of Study From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Grube, MD | Practice for General Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube | Berlin | State of Berlin | 10709 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26074990 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IQP-VV-102 | 2 tablets twice a day IQP-VV-102 |
| FG001 | Placebo | 2 tablets twice a day Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
*Only 117 out of 118 subjects included in the intention-to-treat population as one subject was lost to follow-up after visit 3
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| ID | Title | Description |
|---|---|---|
| BG000 | IQP-VV-102 | 2 tablets twice a day IQP-VV-102 |
| BG001 | Placebo | 2 tablets twice a day Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight at End of Study Compared to Baseline | Change in body weight at the end of study compared to baseline | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
12 weeks
All adverse effect reported were not deemed associated with the investigational product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IQP-VV-102 | 2 tablets twice a day IQP-VV-102 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christof Jänicke | Analyze & Realize GmBH | +49 30 40 00 83 23 | cj@a-r.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
Measured in kg using calibrated weighing scales
| 12 weeks |
| Adverse Event |
|
| BG002 |
| Total |
Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Change in Waist Circumference (in cm) at End of Study From Baseline | Difference in waist circumference (in cm) at end of study from baseline | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
|
|
| Secondary | Change in Mean Body Fat at End of Study From Baseline | Measured in kg using calibrated weighing scales | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
|
| 0 |
| 57 |
| 5 |
| 57 |
| EG001 | Placebo | 2 tablets twice a day Placebo | 0 | 60 | 8 | 60 |
| Respiratory infections | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vomitting and diarhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypothyrodism | Endocrine disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Bruised left thigh | General disorders | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |