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
1 other identifier
interventional
32
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 29, 2016
January 1, 2016
1.2 years
January 22, 2016
January 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline adipocytes size at 3 months
Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.
Evaluation performed at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Secondary Outcomes (22)
Evaluation of body composition
Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of cellulite grade
Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of body weight
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).
Evaluation of glycemia
Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of insulinemia
Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
- +17 more secondary outcomes
Other Outcomes (1)
Number of participants with treatment-related adverse events
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).
Study Arms (2)
SODB Dimpless-caloric restriction
EXPERIMENTALThis arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction.
Placebo-caloric restriction
PLACEBO COMPARATORThis arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction.
Interventions
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
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 recommendation reduced by 20%
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bionovlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire Thalamas
CIC Hopital Purpan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2016
First Posted
January 29, 2016
Study Start
February 1, 2016
Primary Completion
May 1, 2017
Study Completion
January 1, 2018
Last Updated
January 29, 2016
Record last verified: 2016-01