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| Name | Class |
|---|---|
| Eurofins Optimed | INDUSTRY |
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A randomized, double-blind, placebo-controlled, multi-center, parallel group study on overweight and obese individuals following healthy lifestyle consisting of calorie-reduced diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once compared to the baseline steps)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Active | Experimental | Bifidobacterium animalis ssp. lactis 420 at 1*10^10 colony forming units (CFU) per day |
|
| Group Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily intake of study product | Dietary Supplement | Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total body fat mass relative change | Difference in total body fat mass relative change from baseline (Visit 2) to 6 months of product intake (Visit 5) between the active vs. placebo group | Change from baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Trunk fat mass change | Change in trunk fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline at 2 months, 4 months and 6 months |
| Waist circumference change |
| Measure | Description | Time Frame |
|---|---|---|
| Food intake change | Change in food intake from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Physical activity change |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN nutriment | Dijon | 21000 | France | |||
| Eurofins Optimed |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Change in waist circumference from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
| Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Android fat mass change | Change in android fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Lean body mass change | Change in lean body mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Energy intake change | Change in energy intake from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Fat mass change in individual body regions | Change in fat mass in other individual body regions from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Total fat mass absolute change | Change in total body fat mass absolute change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Body weight change | Change in body weight from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| BMI change | Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative) | Change from baseline at 6 months |
| Hip circumference change | Change in hip circumference from baseline (Visit 2) to, 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Total fat mass relative change | Change in total body fat mass relative change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4) | Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4) |
Change in physical activity (IPAQ) from baseline (Visit 2) to 6 months (Visit 5)
| Change from baseline at 6 months |
| Daily activity change | Change in daily activity (steps, pedometer/accelerometer) from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) |
| Fasting glucose levels change | Change in fasting glucose levels from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Fasting insulin levels change | Change in fasting insulin levels from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Insulin resistance change | Change in insulin resistance from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| HbA1c change | Change in glycated hemoglobin HbA1c from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Blood lipids change | Change in blood lipids from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Inflammation markers change | Change in inflammation markers, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Circulating zonulin change | Change in circulating zonulin from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Barrier function and endotoxemia markers change | Change in markers of gut barrier function and endotoxemia, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Fecal microbiota change | Change in fecal microbiota from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Fecal metabolites change | Change in fecal metabolites from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Adipose tissue biomarkers change | Change in adipose tissue biomarkers, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months |
| Gières |
| 38610 |
| France |
| Biofortis SAS | Saint-Herblain | 44800 | France |
| Cap Vallcarca | Barcelona | 08023 | Spain |
| CAP Centelles | Barcelona | 8540 | Spain |
| CAP Hostalets | Barcelona | Spain |
| CAP Muralles | Tarragona | 43002 | Spain |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |