- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667691
Evaluation of SODB® in Metabolic Adaptations in Overweight Women (SORESCAL)
Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dominique Lacan
- Phone Number: 33(0)6 84 95 39 95
- Email: dominique.lacan@bionov.fr
Study Contact Backup
- Name: Julie Carillon
- Phone Number: 33(0)640201478
- Email: jc.rech@bionov.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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 recommendation reduced by 20%
|
Placebo Comparator: Placebo-caloric restriction
This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction.
|
Caloric recommendation reduced by 20%
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline adipocytes size at 3 months
Time Frame: Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.
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Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of body composition
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by Dual energy X-ray absorptiometry (DEXA).
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of cellulite grade
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by a score.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of body weight
Time Frame: 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).
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Evaluation performed by body weight measurements.
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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).
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Evaluation of glycemia
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by glucose measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of insulinemia
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by insulin measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of non esterified fatty acids level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by non esterified fatty acids measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of triglycerides level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by triglycerides measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of cholesterol level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by cholesterol measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of glycerol level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by glycerol measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of adipokines level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
|
Evaluation performed by adipokines measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of C-reactive protein (CRP) level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by CRP measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of albumin level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by albumin measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of prealbumin level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by prealbumin measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of retinol binding protein (RBP) level
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by RBP measurements.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of adipocytes size
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of adipocytes number
Time Frame: 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 at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of fibrosis
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by immunohIstology (red sirius coloration) in subcutaneous abdominal and gluteo-femoral adipose tissues.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation of macrophage infiltration
Time Frame: 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.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Adipose tissue secretions of glycerol
Time Frame: 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
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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
Time Frame: 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
|
Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Adipose tissue secretions of adipokines
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Adipose tissue genetic profile modifications
Time Frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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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.
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Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events
Time Frame: 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).
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All the adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events.
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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).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claire Thalamas, CIC Hopital Purpan
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A01974-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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