Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Weightloss
研究概览
简要总结
Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist Doctor for weight loss and loss of fat percentage in patients who need it.
详细描述
Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist Doctor for weight loss and loss of fat percentage in patients who need it. The feeding is by nasogastric-duodenal tube depending on the desired fat loss and / or weight in relation to the basal metabolism. Feeding by tube of 12-29 days, continuing with personalized nutritional treatment for 2 weeks and physical activity during the protocol. Losses of weight and / or expected fat greater than 10%. The results will be compared with bariatric surgery. The main objective is to provide a tool for the obesity epidemic that can be applied worldwide by doctors without the complications of surgery and with a lower price for health systems and controlling the actions of the hormones leptin and ghrelin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Desire for weight loss, desire to improve body image, voluntariness
排除标准
- •esophageal alteration or swallowing, not sign the informed consent, acute active disease
研究组 & 干预措施
Nasogastroduodenal Protocol
Evaluation of a protocol for the treatment of excess body fat through duodenal nutrition
干预措施: Nasogastroduodenal Protocol (Dietary Supplement)
Controls
Change from Baseline Body Composition values at 1 and 3 months
干预措施: Control (Other)
Data analysis
Analysis and publication of data
干预措施: Data analysis (Other)
结局指标
主要结局
Weightloss
时间窗: Change from Baseline weight at 1 and 3 months
Decrease, minor difference in weight at the end of treatment
次要结局
- Fat loss(Change from Baseline fat percentage at 1 and 3 months)
- Loss of measures(Change from Baseline measures at 1 and 3 months)
研究者
Isaac Kuzmar, MD, MBT, MsCN, PhD
Principal Investigator
BiomediKcal