Efficacy of a Specific Complete Formula on Nutritional Status and Coverage of Protein Requirements After Obesity Surgery Compared to the Traditional Progressive Diet: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- evaluate nutritional deficiencies
研究概览
简要总结
The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.
Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:
- Analytical determination
- Nitrogen balance by determining urea N2 in 24-hour urine
- Anthropometric determinations
- Body composition determined by impedanciometry
- Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
- Energy, protein and hydration intake.
- Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Patients of both sexes between 18 and 65 years of age undergoing bariatric surgery in our center With the ability to understand the objectives and proposals of the study That they agree to participate in the study.
排除标准
- •Patients who have had perioperative complications and who require an extended hospital stay Patients who after the intervention require some type of artificial nutritional support Patients who have undergone a surgical technique other than BPG.
研究组 & 干预措施
High protein liquid formula
Patients allocated in the intervention group (n=15) received 4 high-protein shakes and the corresponding standard vitamin-mineral (VM) supplementation according to our post BS protocol, then progressed towards a diet that combines traditional foods with 2 hLF shakes per day and VM supplementation for 15 days. Over the following 15 days, patients continued to normalize their diet, including a single hLF shake per day and continued with VM supplementation.
干预措施: High protein liquid formula (Dietary Supplement)
Standard care diet
Patients in the control group (n=35) followed the traditional protocol after bariatric surgery (sCD-group) consisting of a progressive diet with traditional foods, recommendation of 23g/d of protein powder and standard vitamin-mineral supplementation during the first 2 weeks after the surgery. From then on and according to current dietary protocols, the recommendation for protein powder decreases from 23g to 15g up to the end of the study.
结局指标
主要结局
evaluate nutritional deficiencies
时间窗: 2 months
Nutritional status and the preservation of lean mass during the rapid phase of weight loss
protein intake
时间窗: 2 months
Achieving the protein intake goal established for patients after obesity surgery.
Tolerance
时间窗: 2 months
Gastrointestinal tolerance during the first two months after surgery.
次要结局
未报告次要终点
研究者
Violeta Moizé
PhD
Hospital Clinic of Barcelona