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Study was terminated because of conflicting results from intermediate analysis.
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The purpose of this clinical trial is to evaluate the safety and efficacy of a food supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight subjects during 12 weeks treatment.
Overweight and obesity represent a serious public health issue. These conditions are characterized by an abnormal or excessive accumulation of body fat mass and they are related to an increase risk of developing chronic diseases such as cardiovascular, diabetes, arthrosis and certain kind of cancer (breast; colon). It's thus necessary to find new products able to counteract both overweight and obesity.
Omnia is a food supplement based on a Phaseolus vulgaris extract. It has pancreatic amylase inhibition properties.
In the following clinical trial, OMNIA will be administrated to a group of overweight subjects in order to evaluate its efficacy on reducing the body fat mass. Its action will be compared to a placebo administered to a second group of overweight volunteers with the same modalities as OMNIA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnia group | Experimental | After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks. |
|
| Placebo group | Placebo Comparator | After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnia | Dietary Supplement | 12weeks of treatment |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Body Mass Index (BMI) | 6, 12 weeks | |
| change from baseline on the ratio fat/lean body mass measured by DEXA | 12 weeks | |
| change from baseline on weight |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Dietary Supplement |
12weeks of treatment |
|
| 6, 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |