NCT01739998已完成4 期
Randomized, Double-blind, Controlled Study to Evaluate the Efficacy of Omega 3 Fatty Acids on Different Inflammatory Markers in Obese Subjects With Dietary Intervention for Weight Lost
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Inflammatory markers
研究概览
简要总结
Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from fish oil) on different inflammatory markers in obese subjects with dietary intervention for weight lost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 30 to 75 years old.
- •Body mass index (BMI) ≥ 30 kg/m2
- •Signed informed consent.
排除标准
- •Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
- •Individuals with Diabetes Mellitus insulin dependent.
- •Individuals with disorders associated with eating behaviour.
- •Individuals with mental disease or low cognitive function.
- •Individuals with consumption of drugs to weight lost.
- •Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
- •Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.)
- •Pregnant women or lactating.
- •Individuals with recurrent infections.
- •Individuals with regular consumption of anti-inflammatory or glucocorticoids.
- •Individuals with consumption of oil fish supplements (except if they gave up its consumption 1 month before).
- •Individuals with fish allergy.
- •Individuals with consumption of more than two fatty fish servers twice a week.
- •Individuals with physical problems complying with the recommendations of physical activity and diet indicated.
结局指标
主要结局
Inflammatory markers
时间窗: 2 months
Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR
次要结局
- Motivation and Satiety Parameters(0 and 2 month)
- Anthropometric parameters(0.1 and 2 months)
- Lipid profile(0.1 and 2 months)
- Hormonal Parameters(0.2 months)
- Oxidative Stress Parameters(0 and 2 months)
- Glucosa Metabolism(0, 1 and 2 months)
- Depression Test(0 and 2 months)
- Adeherence and Tolerance parameters(up to 2 months)
研究者
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