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

Primary Purpose

Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SODB Dimpless
Placebo
caloric restriction
Sponsored by
Bionov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring superoxyde dismutase, melon concentrate, oxydative stress, overweight women

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    SODB Dimpless-caloric restriction

    Placebo-caloric restriction

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change from baseline adipocytes size at 3 months
    Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.

    Secondary Outcome Measures

    Evaluation of body composition
    Evaluation performed by Dual energy X-ray absorptiometry (DEXA).
    Evaluation of cellulite grade
    Evaluation performed by a score.
    Evaluation of body weight
    Evaluation performed by body weight measurements.
    Evaluation of glycemia
    Evaluation performed by glucose measurements.
    Evaluation of insulinemia
    Evaluation performed by insulin measurements.
    Evaluation of non esterified fatty acids level
    Evaluation performed by non esterified fatty acids measurements.
    Evaluation of triglycerides level
    Evaluation performed by triglycerides measurements.
    Evaluation of cholesterol level
    Evaluation performed by cholesterol measurements.
    Evaluation of glycerol level
    Evaluation performed by glycerol measurements.
    Evaluation of adipokines level
    Evaluation performed by adipokines measurements.
    Evaluation of C-reactive protein (CRP) level
    Evaluation performed by CRP measurements.
    Evaluation of albumin level
    Evaluation performed by albumin measurements.
    Evaluation of prealbumin level
    Evaluation performed by prealbumin measurements.
    Evaluation of retinol binding protein (RBP) level
    Evaluation performed by RBP measurements.
    Evaluation of adipocytes size
    Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue.
    Evaluation of adipocytes number
    Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues.
    Evaluation of fibrosis
    Evaluation performed by immunohIstology (red sirius coloration) in subcutaneous abdominal and gluteo-femoral adipose tissues.
    Evaluation of macrophage infiltration
    Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues.
    Adipose tissue secretions of glycerol
    Evaluation performed by glycerol measurements in subcutaneous abdominal adipose tissue
    Adipose tissue secretions of non esterified fatty acids
    Evaluation performed by non esterified fatty acids measurements in subcutaneous abdominal adipose tissue
    Adipose tissue secretions of adipokines
    Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue
    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.

    Full Information

    First Posted
    January 22, 2016
    Last Updated
    January 26, 2016
    Sponsor
    Bionov
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02667691
    Brief Title
    Evaluation of SODB® in Metabolic Adaptations in Overweight Women
    Acronym
    SORESCAL
    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

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bionov

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    superoxyde dismutase, melon concentrate, oxydative stress, overweight women

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SODB Dimpless-caloric restriction
    Arm Type
    Experimental
    Arm Description
    This arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction.
    Arm Title
    Placebo-caloric restriction
    Arm Type
    Placebo Comparator
    Arm Description
    This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    SODB Dimpless
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    caloric restriction
    Intervention Description
    Caloric recommendation reduced by 20%
    Primary Outcome Measure Information:
    Title
    Change from baseline adipocytes size at 3 months
    Description
    Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.
    Time Frame
    Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Secondary Outcome Measure Information:
    Title
    Evaluation of body composition
    Description
    Evaluation performed by Dual energy X-ray absorptiometry (DEXA).
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of cellulite grade
    Description
    Evaluation performed by a score.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of body weight
    Description
    Evaluation performed by body weight measurements.
    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).
    Title
    Evaluation of glycemia
    Description
    Evaluation performed by glucose measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of insulinemia
    Description
    Evaluation performed by insulin measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of non esterified fatty acids level
    Description
    Evaluation performed by non esterified fatty acids measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of triglycerides level
    Description
    Evaluation performed by triglycerides measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of cholesterol level
    Description
    Evaluation performed by cholesterol measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of glycerol level
    Description
    Evaluation performed by glycerol measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of adipokines level
    Description
    Evaluation performed by adipokines measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of C-reactive protein (CRP) level
    Description
    Evaluation performed by CRP measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of albumin level
    Description
    Evaluation performed by albumin measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of prealbumin level
    Description
    Evaluation performed by prealbumin measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of retinol binding protein (RBP) level
    Description
    Evaluation performed by RBP measurements.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of adipocytes size
    Description
    Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of adipocytes number
    Description
    Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of fibrosis
    Description
    Evaluation performed by immunohIstology (red sirius coloration) in subcutaneous abdominal and gluteo-femoral adipose tissues.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Evaluation of macrophage infiltration
    Description
    Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Adipose tissue secretions of glycerol
    Description
    Evaluation performed by glycerol measurements in subcutaneous abdominal adipose tissue
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Adipose tissue secretions of non esterified fatty acids
    Description
    Evaluation performed by non esterified fatty acids measurements in subcutaneous abdominal adipose tissue
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Adipose tissue secretions of adipokines
    Description
    Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Title
    Adipose tissue genetic profile modifications
    Description
    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.
    Time Frame
    Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
    Other Pre-specified Outcome Measures:
    Title
    Number of participants with treatment-related adverse events
    Description
    All the adverse events occured throughout the study analyzed in order to know the number of participants only 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).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique Lacan
    Phone
    33(0)6 84 95 39 95
    Email
    dominique.lacan@bionov.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie Carillon
    Phone
    33(0)640201478
    Email
    jc.rech@bionov.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claire Thalamas
    Organizational Affiliation
    CIC Hopital Purpan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Evaluation of SODB® in Metabolic Adaptations in Overweight Women

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