Overweight
Conditions
Keywords
superoxyde dismutase, melon concentrate, oxydative stress, overweight women
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSODB Dimpless
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
DIETARY_SUPPLEMENTPlacebo
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
OTHERcaloric restriction
Caloric recommendation reduced by 20%
Sponsors
Bionov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* overweight women (IMC 25-30 kg/m2) * stable weight (variation \<5% over the last 3 months) * age between 25 and 50 years old * cellulite grade ≥ 2 * women with genital activity * regular menstrual cycles (28 ± 2 days over the last 3 months) * women with efficient contraception (oral, intra-uterine, ligature trunks or other surgery) - same contraception over the last 3 months * women having given her free, informed and express consent. * affiliated with a social security insurance or beneficiary of such an insurance system. * glycemia \< 1,26g/l * Arterial blood pression \< 140/90 mm Hg or stable for at least 2 months * LDL cholesterol \<1,90g/l * triglycerides \<2,50g/l
Exclusion criteria
* untreated dyslipidemia * unstable hypertension * type 1 or 2 diabetes * any history of bariatric surgery * any history of unstable thyroidian diseases * any troubles of hemostasis * any allergy to utilized antiseptic, xylocaine, or to one of the compounds of the experimental or placebo product * excessive coffee consumption (\> 6 cups/day) * consumption of drinks containing xanthic bases (\> 0.5 l/day) * consumption of drinks containing grapefruit juice (\> 0.5 l/day) * consumption of drinks containing plants (\> 2 l/day) * medication with draining, lipolytic, anorexigenic activity * current or recent (in the previous month) antioxidant supplementation (vitamine A, C, E, beta-carotene, lutein, lycopene, selenium) * recent (in the previous year) local anti-cellulite treatment * thigh liposuction in the last 2 years * under current anticoagulant treatment * under current neuroleptic treatment * under current corticotherapy (local or systemic) treatment * under current diuretic treatment * under current antiinflammatory treatment that cannot be interrupted * under current treatment which interferes with autonomous nervous system and lipids metabolism * triglycérides \> 2.50g/l * LDL cholesterol \>1.90 * positive serology for hepatitis B, C and HIV * consumption of more than 66g/day of alcohol * venous fragility not allowing to support catheters during the visits. * adult protected by the law * any subject who participated to a clinical assay within the 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline adipocytes size at 3 months | Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of body composition | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by Dual energy X-ray absorptiometry (DEXA). |
| Evaluation of cellulite grade | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by a score. |
| Evaluation of body weight | 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 performed by body weight measurements. |
| Evaluation of glycemia | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by glucose measurements. |
| Evaluation of insulinemia | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by insulin measurements. |
| Evaluation of non esterified fatty acids level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by non esterified fatty acids measurements. |
| Evaluation of triglycerides level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by triglycerides measurements. |
| Evaluation of cholesterol level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by cholesterol measurements. |
| Evaluation of glycerol level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by glycerol measurements. |
| Evaluation of adipokines level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by adipokines measurements. |
| Evaluation of C-reactive protein (CRP) level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by CRP measurements. |
| Evaluation of prealbumin level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by prealbumin measurements. |
| Evaluation of retinol binding protein (RBP) level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by RBP measurements. |
| Evaluation of adipocytes size | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue. |
| Evaluation of adipocytes number | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues. |
| Evaluation of fibrosis | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by immunohIstology (red sirius coloration) in subcutaneous abdominal and gluteo-femoral adipose tissues. |
| Evaluation of macrophage infiltration | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues. |
| Adipose tissue genetic profile modifications | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | 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. |
| Adipose tissue secretions of glycerol | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by glycerol measurements in subcutaneous abdominal adipose tissue |
| Adipose tissue secretions of non esterified fatty acids | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by non esterified fatty acids measurements in subcutaneous abdominal adipose tissue |
| Adipose tissue secretions of adipokines | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue |
| Evaluation of albumin level | Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3). | Evaluation performed by albumin measurements. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants 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). | All the adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events. |
Contacts
Primary ContactDominique Lacan
Backup ContactJulie Carillon
Outcome results
None listed