Evaluation of SODB® in Metabolic Adaptations in Overweight Women

Overweight Clinical Trial

— SORESCAL  

Official title:

Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02667691
• Other study ID #: 2014-A01974-43
• Status: Not yet recruiting
• Phase: N/A
• First received: January 22, 2016
• Last updated: January 26, 2016
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Bionov
• Contact: Dominique Lacan
• Phone: 33(0)6 84 95 39 95
• Email: dominique.lacan[@]bionov.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

• triglyce´rides > 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• 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

Other:
• caloric restriction
Caloric recommendation reduced by 20%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bionov

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events	All the adverse events occured throughout the study analyzed in order to know the number of participants only 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).	Yes
Primary	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).	No
Secondary	Evaluation of body composition	Evaluation performed by Dual energy X-ray absorptiometry (DEXA).	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of cellulite grade	Evaluation performed by a score.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of body weight	Evaluation performed by body weight measurements.	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).	No
Secondary	Evaluation of glycemia	Evaluation performed by glucose measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of insulinemia	Evaluation performed by insulin measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of non esterified fatty acids level	Evaluation performed by non esterified fatty acids measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of triglycerides level	Evaluation performed by triglycerides measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of cholesterol level	Evaluation performed by cholesterol measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of glycerol level	Evaluation performed by glycerol measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of adipokines level	Evaluation performed by adipokines measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of C-reactive protein (CRP) level	Evaluation performed by CRP measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of albumin level	Evaluation performed by albumin measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of prealbumin level	Evaluation performed by prealbumin measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of retinol binding protein (RBP) level	Evaluation performed by RBP measurements.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of adipocytes size	Evaluation performed by immunohistology in subcutaneous gluteo-femoral adipose tissue.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Evaluation of adipocytes number	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).	No
Secondary	Evaluation of fibrosis	Evaluation performed by immunohIstology (red sirius coloration) 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).	No
Secondary	Evaluation of macrophage infiltration	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).	No
Secondary	Adipose tissue secretions of glycerol	Evaluation performed by glycerol measurements in subcutaneous abdominal adipose tissue	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	Adipose tissue secretions of non esterified fatty acids	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).	No
Secondary	Adipose tissue secretions of adipokines	Evaluation performed by adipokines measurements in subcutaneous abdominal adipose tissue	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No
Secondary	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.	Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).	No