Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Weight
研究概览
简要总结
The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.
详细描述
Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized in blocks of two participants, at a 1:1 ratio, for the two groups of treatment. For every two participants, there will be one block. The number of each block will be hold in a nontransparent, seriated, sealed envelope. Intervention capsules will be opaque and stored in identical containers by a single investigator, who will not take part in data collection or analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30kg/m2
- •Candidate to bariatric and metabolic surgery
排除标准
- •Use of Omega-3
- •Contraindication to bioimpedance analysis
- •Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics
- •Refusal to participate
结局指标
主要结局
Weight
时间窗: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Measurement with digital scale, patient standing, barefoot. kilograms (kg)
Height
时间窗: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Height measurement, patient standing, barefoot. Unit of measurement: meters (m).
次要结局
- Electrical Bioimpedance - Percentage of muscle mass(Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.)
- Electrical Bioimpedance - Body fat percentage(Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.)
- Manual Grip Strength(Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.)
- 6-Minute Walk Test(Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.)