Use of New Food Products (Food for Special Medical Purposes) in the Period Post-bariatric Surgery Weaning to Increase Patient Compliance Diet and Avoid Nutritional Deficiencies.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Patient compliance throughout the weaning period
研究概览
简要总结
Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomical changes in the vagus that may contribute to the alteration of taste perception. In order to facilitate patient weaning and improve the liking of the foods used in this semi-liquid phase, our Center intends to test some "Foods for Special Medical Purposes" (AFMS), in order to ensure a better intake of nutrition, including in terms of vitamin D3 and calcium, good palatability and thus a better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.
详细描述
Primary goal: Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable by Sensory Questionnaire.
Secondary objective:
- Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable with test comparative
- Taste perception, liking, palatability and food preferences among the different products (Special Medical Purpose Foods-AFMS vs homogenized foods) and between pre and post bariatric surgery.
- Nutritional efficacy (assessment of blood levels of micronutrients such as. iron, ferritin, transferrin , calcium, vit D3, folic ac, vit B12 and of macronutrients such as total protein and protein electrophoresis; bioimpedance analysis for body composition assessment).
32 subjects with severe or morbid obesity ( BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2 , respectively), male and female, candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
Two timepoints: T0 (pre-rev) and T1 (follow-up 1 month +/-7 days). Planned assessments at T0 and T1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥18 and ≤ of 60
- •Subjects with severe or morbid obesity (BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2)
- •Absence of diagnosis of primary obesity
- •Absence of medical/psychiatric contraindications
- •Signature of informed consent for the study
- •Patients who are candidates by clinical practice for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
排除标准
- •Presence of chronic diseases of the digestive system, such as chronic diseases intestinal, malabsorption syndrome, diverticulosis of the colon
- •Current pregnancy (verified by self-declaration) and/or lactation
- •Subjects with endocrine disorders (e.g., Cushing's m., thyroid disease uncontrolled)
- •Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl and eGFR < 60 ml/min
- •Presence of malignant pathology
- •Alcohol or drug abuse
- •Severe psychological/psychiatric disorders
- •Difficulty adhering to the protocol due to language barriers or other reasons.
研究组 & 干预措施
Group A (AFSM)
16 subjects (Group A: intervention group) will take AFSMs in the immediate postoperative period (Appendix A). A weaning period with AFSM nutritional protocol of 4 weeks is planned, the weaning will cover the entire observation period T0 → T1.
干预措施: Foods for Special Medical Purposes (Dietary Supplement)
Group B (protocol in use with homogenized)
16 subjects (Group B: control group) will follow the standard weaning protocol i.e. with homogenized food (Appendix B). A weaning period with nutritional protocol, as per clinical protocol, of 4 weeks is planned, weaning will cover the entire observation period T0 → T1.
结局指标
主要结局
Patient compliance throughout the weaning period
时间窗: 1 month
Patient compliance throughout the weaning period (4 weeks post-intervention), assessed through satisfaction with the products measurable with a questionnaire sensory.
次要结局
未报告次要终点