Evaluation of SODB® in Metabolic Adaptations in Overweight Women (SORESCAL)

Bionov

Status: Unknown

Conditions: Overweight

Treatments: Dietary Supplement: Placebo; Other: caloric restriction; Dietary Supplement: SODB Dimpless

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667691

2014-A01974-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

SODB Dimpless-caloric restriction

Experimental group

Description:

This arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction.

Treatment:

Dietary Supplement: SODB Dimpless

Other: caloric restriction

Placebo-caloric restriction

Placebo Comparator group

Description:

This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction.

Treatment:

Other: caloric restriction

Dietary Supplement: Placebo