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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
32
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
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 recommendation reduced by 20%
Change from baseline adipocytes size at 3 months
Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.
Time frame: Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of body composition
Evaluation performed by Dual energy X-ray absorptiometry (DEXA).
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of cellulite grade
Evaluation performed by a score.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).