OverweightSORESCALNCT02667691
Evaluation of SODB® in Metabolic Adaptations in Overweight Women
A study testing SODB Dimpless and caloric restriction in people with Overweight, run by Robertet SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- SODB Dimpless and caloric restriction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- untreated dyslipidemia
- unstable hypertension
- type 1 or 2 diabetes
- any history of bariatric surgery
- any history of unstable thyroidian diseases
- any troubles of hemostasis
Show all 28Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- SODB Dimpless, Placebo, caloric restriction
- Keywords
- superoxyde dismutase, melon concentrate, oxydative stress, overweight women
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SODB DimplessDietary supplement
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
PlaceboDietary supplement
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 restrictionOther
Caloric recommendation reduced by 20%
| Study group | Role | What they receive |
|---|---|---|
| SODB Dimpless-caloric restriction | Experimental | This arm receives daily two capsules of SODB Dimpless 40mg containing 480 UI of superoxide dismutase (SOD), associated with a moderate caloric restriction. Receives: Dietary Supplement: SODB Dimpless; Other: caloric restriction |
| Placebo-caloric restriction | Placebo comparator | This arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction. Receives: Dietary Supplement: Placebo; Other: caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline adipocytes size at 3 months
Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.
Measured: 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 performed by Dual energy X-ray absorptiometry (DEXA).
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of cellulite grade
Evaluation performed by a score.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of body weight
Evaluation performed by body weight measurements.
Measured: 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 performed by glucose measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of insulinemia
Evaluation performed by insulin measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of non esterified fatty acids level
Evaluation performed by non esterified fatty acids measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of triglycerides level
Evaluation performed by triglycerides measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of cholesterol level
Evaluation performed by cholesterol measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of glycerol level
Evaluation performed by glycerol measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of adipokines level
Evaluation performed by adipokines measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of C-reactive protein (CRP) level
Evaluation performed by CRP measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of albumin level
Evaluation performed by albumin measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of prealbumin level
Evaluation performed by prealbumin measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of retinol binding protein (RBP) level
Evaluation performed by RBP measurements.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of adipocytes size
Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of adipocytes number
Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of fibrosis
Evaluation performed by immunohIstology (red sirius coloration) in subcutaneous abdominal and gluteo-femoral adipose tissues.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of macrophage infiltration
Evaluation performed by immunohistology in subcutaneous abdominal and gluteo-femoral adipose tissues.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Adipose tissue secretions of glycerol
Evaluation performed by glycerol measurements in subcutaneous abdominal adipose tissue
Measured: 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
Evaluation performed by non esterified fatty acids measurements in subcutaneous abdominal adipose tissue
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Adipose tissue secretions of adipokines
Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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.
Measured: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robertet SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire Thalamas, Principal investigator, CIC Hopital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667691
- Sponsor's protocol ID
- 2014-A01974-43
- Acronym
- SORESCAL
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo
- ClinicalTrials.gov ID
- NCT02667691
- Acronym / sponsor ID
- SORESCAL / 2014-A01974-43
- Conditions
- Overweight
- Keywords
- superoxyde dismutase, melon concentrate, oxydative stress, overweight women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Robertet SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SODB Dimpless-caloric restriction | Experimental | Dietary Supplement: SODB Dimpless, Other: caloric restrictionThis 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 comparator | Dietary Supplement: Placebo, Other: caloric restrictionThis arm receives daily two capsules Placebo containing excipients only, associated with a moderate caloric restriction. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (28 listed)
- untreated dyslipidemia
- unstable hypertension
- type 1 or 2 diabetes
- any history of bariatric surgery
- any history of unstable thyroidian diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SODB DimplessSubjects 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 | Dietary supplement | SODB Dimpless-caloric restriction |
| PlaceboSubjects 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 | Dietary supplement | Placebo-caloric restriction |
| caloric restrictionCaloric recommendation reduced by 20% | Other | Placebo-caloric restriction, SODB Dimpless-caloric restriction |
Primary outcome
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).
Evaluation performed by immunohistology in subcutaneous abdominal adipose tissue.
22 secondary outcomes
Evaluation of body composition
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of cellulite grade
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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).
Evaluation of glycemia
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of insulinemia
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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).
Evaluation of triglycerides level
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of cholesterol level
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of glycerol level
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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 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).
Evaluation of albumin level
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of prealbumin level
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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).
Evaluation of adipocytes size
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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 of fibrosis
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
Evaluation of macrophage infiltration
Time frame: Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Thalamas principal investigator
CIC Hopital Purpan
Questions about this trial
What is this clinical trial studying?
A study testing SODB Dimpless and caloric restriction in people with Overweight, run by Robertet SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Lacan (33(0)6 84 95 39 95, dominique.lacan@bionov.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.