The Effect of ω-3 Polyunsaturated Fatty Acids (Eicosapentaenoic Acid and Docosahexanoic Acid) on Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Decrease of inflammatory levels on blood
研究概览
简要总结
Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?
详细描述
Intake of EPA and DHA for the management of morbid obesity in capsules
- Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein, cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of omega 3 capsules and placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18-65 years,
- •BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities),
- •ambulatory, receiving an oral diet,
- •with a diagnosis of metabolic syndrome,
- •and who signed a Term of Free and Informed Consent.
排除标准
- •Systemic inflammatory response syndrome,
- •coma or compromised organ,
- •fever or infection foci,
- •cancer with or without chemotherapy and radiotherapy,
- •radiotherapy, inflammatory diseases of the gastrointestinal tract,
- •transplant, trauma, surgery or hospital stay in the past 30 days
- •use of steroids or non-steroid anti-inflammatory or immunomodulators agents or antibiotics,
- •or those refusing to take part in the study.
结局指标
主要结局
Decrease of inflammatory levels on blood
时间窗: 08 weeks
expected from this study verify inflammatory factors such as adipokines, glucose, c reactive protein, lipid profile, triglycerides, and anthropometric data as visceral fat, weight, BMI, in both groups, control and intervention, to see the action of the capsules of omega 3.patient may withdraw any time from ingestion of capsules, and the same will be provided by the laboratory Vitamed, which is regularized with the supervisory bodies and food security of Brazil
次要结局
- Decrease of weight(08 weeks)