Evaluation of SODB® in Metabolic Adaptations in Overweight Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: SODB Dimpless
* Dietary Supplement: Placebo
* Other: caloric restriction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SODB Dimpless-caloric restriction<br>This arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction. | Dietary Supplement: SODB Dimpless<br>* 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<br>Other: caloric restriction<br>* Caloric recommendation reduced by 20%<br>|
| Placebo Comparator: Placebo-caloric restriction<br>This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction. | Dietary Supplement: Placebo<br>* 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<br>Other: caloric restriction<br>* Caloric recommendation reduced by 20%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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superoxyde dismutase, melon concentrate, oxydative stress, overweight women