Evaluation of SODB® in Metabolic Adaptations in Overweight Women
NCT ID: NCT02667691
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2016-02-29
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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SODB Dimpless-caloric restriction
This arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction.
SODB 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
caloric restriction
Caloric recommendation reduced by 20%
Placebo-caloric restriction
This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction.
Placebo
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 restriction
Caloric recommendation reduced by 20%
Interventions
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SODB 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
Placebo
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 restriction
Caloric recommendation reduced by 20%
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
50 Years
FEMALE
Yes
Sponsors
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Bionov
INDUSTRY
Responsible Party
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Principal Investigators
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Claire Thalamas
Role: PRINCIPAL_INVESTIGATOR
CIC Hopital Purpan
Central Contacts
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Other Identifiers
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2014-A01974-43
Identifier Type: -
Identifier Source: org_study_id