Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the influence of a 3 months SODB® supplementation in adipose tissue modulations of overweight women, in comparison to a placebo.
Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to induce endogenous antioxidant defence, and then reduce oxidative stress generally observed in overweight adipose tissue.
Moreover, this study could evaluate the impact of a decrease in oxidative stress on the others overweight-induced disorders, such as insulin resistance, inflammation, fibrosis, lipolyse alterations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SODB Dimpless-caloric restriction | Experimental | This arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction. |
|
| Placebo-caloric restriction | Placebo Comparator | This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SODB Dimpless | Dietary Supplement | Subjects are supplemented with SODB, daily over 3 Months. Each volunteer was seen for the 4 visits: - visit of pre-inclusion, - visit V1, so-called inclusion visit, - visit V2 at 1,5 months and - visit V3 at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline adipocytes size at 3 months | Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue. | Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of body composition | Evaluation performed by Dual energy X-ray absorptiometry (DEXA). | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of cellulite grade |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | All the adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events. | Evaluation at inclusion day (V1), after 1.5 months of treatment (V2), and after 3 months of treatment at the end of the study (V3). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Lacan | Contact | 33(0)6 84 95 39 95 | dominique.lacan@bionov.fr | |
| Julie Carillon | Contact | 33(0)640201478 | jc.rech@bionov.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire Thalamas | CIC Hopital Purpan | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Subjects are supplemented with placebo, daily over 3 Months. Each volunteer was seen for the 4 visits: - visit of pre-inclusion, - visit V1, so-called inclusion visit, - visit V2 at 1,5 months and - visit V3 at 3 months |
|
| caloric restriction | Other | Caloric recommendation reduced by 20% |
|
Evaluation performed by a score.
| Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of body weight | Evaluation performed by body weight measurements. | Evaluation at inclusion day (V1), after 1.5 months of treatment (V2), and after 3 months of treatment at the end of the study (V3). |
| Evaluation of glycemia | Evaluation performed by glucose measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of insulinemia | Evaluation performed by insulin measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of non esterified fatty acids level | Evaluation performed by non esterified fatty acids measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of triglycerides level | Evaluation performed by triglycerides measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of cholesterol level | Evaluation performed by cholesterol measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of glycerol level | Evaluation performed by glycerol measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of adipokines level | Evaluation performed by adipokines measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of C-reactive protein (CRP) level | Evaluation performed by CRP measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of albumin level | Evaluation performed by albumin measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of prealbumin level | Evaluation performed by prealbumin measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of retinol binding protein (RBP) level | Evaluation performed by RBP measurements. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of adipocytes size | Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of adipocytes number | Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of fibrosis | Evaluation performed by immunohIstology (red sirius coloration) in subcutaneous abdominal and gluteo-femoral adipose tissues. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Evaluation of macrophage infiltration | Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Adipose tissue secretions of glycerol | Evaluation performed by glycerol measurements in subcutaneous abdominal adipose tissue | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Adipose tissue secretions of non esterified fatty acids | Evaluation performed by non esterified fatty acids measurements in subcutaneous abdominal adipose tissue | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Adipose tissue secretions of adipokines | Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| Adipose tissue genetic profile modifications | Evaluation of genes (all human known genes tested) differentially expressed in the two arms of subjects performed by DNA microarrays in subcutaneous abdominal adipose tissue. | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |