NCT02667691Unknown不适用
Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Bionov
- 入组人数
- 32
- 主要终点
- Change from baseline adipocytes size at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change from baseline adipocytes size at 3 months
时间窗: 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.
次要结局
- Evaluation of cellulite grade(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 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 cholesterol level(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of body composition(Evaluation at inclusion day (V1) 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 glycerol level(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of prealbumin level(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of adipocytes number(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Adipose tissue secretions of glycerol(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Adipose tissue secretions of adipokines(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).)
- Evaluation of adipocytes size(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of triglycerides level(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of adipokines level(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 at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of albumin level(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Adipose tissue genetic profile modifications(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 at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of fibrosis(Evaluation at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
- Evaluation of macrophage infiltration(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 at inclusion day (V1) and after 3 months of treatment at the end of the study (V3).)
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