Mediterranean-style and Open Protein Diet Plans on Weight Loss in Patients With Obesity After Endoscopic Bariatric Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 主要终点
- Weekly weight loss
研究概览
简要总结
All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position.
Intervention: Participants followed a liquid diet plan during the first week after the endoscopic bariatric procedure (Bioenterics Intragastric Balloon - BIB - or Primary Obesity Surgery Endoluminal - POSE -). Subsequently, subjects were randomly assigned either a Mediterranean-style or a protein diet plan. Energy intake was calculated according to the Spanish Consensus on Bariatric Endoscopy.
The hypothesis of this project is to analyze whether the Mediterranean-style diet is more effective compared with the open protein diet plans in weight loss and weight relapse in subjects with obesity who underwent endoscopic bariatric therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •no previous gastric intervention
- •no hiatus hernias
- •not being pregnant or in breastfeeding
- •not having cardiac problems, and having regular values in coagulation and blood count,
- •having a positive psychological evaluation.
排除标准
- •lack of compliance with the dietary treatment
- •adverse effects of the surgery
- •refuse to complete the treatment
- •lack of adherence
结局指标
主要结局
Weekly weight loss
时间窗: Every week up to 24 weeks
Weight relapse after 36 weeks
时间窗: 1 time after 36 weeks
次要结局
未报告次要终点
研究者
Antonio Sanchez Egea
Assistant Professor
Universitat Politècnica de Catalunya