Clinical trial NCT02667691: Evaluation of SODB® in Metabolic Adaptations in Overweight Women
Official title: Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Keywords: superoxyde dismutase
melon concentrate
oxydative stress
overweight women
Lead sponsor: Bionov
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline adipocytes size at 3 months
timeFrame: Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Secondary outcomes:
measure: Evaluation of body composition
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of cellulite grade
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of body weight
timeFrame: 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).
measure: Evaluation of glycemia
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of insulinemia
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of non esterified fatty acids level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of triglycerides level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of cholesterol level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of glycerol level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of adipokines level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of C-reactive protein (CRP) level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of albumin level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of prealbumin level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of retinol binding protein (RBP) level
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of adipocytes size
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of adipocytes number
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of fibrosis
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Evaluation of macrophage infiltration
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Adipose tissue secretions of glycerol
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Adipose tissue secretions of non esterified fatty acids
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Adipose tissue secretions of adipokines
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
measure: Adipose tissue genetic profile modifications
timeFrame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Other outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 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).
Locations:
Study officials:
affiliation: CIC Hopital Purpan
name: Claire Thalamas
role: PRINCIPAL_INVESTIGATOR
References: