Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients with Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Compare the digestive tolerance of an oligomeric nutritional supplement with respect to a polymeric nutritional supplement in a group of patients diagnosed with anorexia nervosa under follow-up by the Nutrition Unit.
研究概览
简要总结
Anorexia nervosa causes gastroparesis, constipation, and can lead to elevated liver enzymes. It is often necessary to supplement the diet of patients with nutritional formulas. The ingestion of a peptide formula, with partially hydrolyzed protein and rich in medium chain triglycerides, could favor its digestion and absorption, improving its tolerance and acceptance by the patient, compared to a polymeric formula.
详细描述
Main objective:
• To compare the digestive tolerance of an oligomeric nutritional supplement with respect to a polymeric nutritional supplement in a group of patients diagnosed with anorexia nervosa under follow-up by the Nutrition Unit.
Secondary Objectives:
- Assess the gastrointestinal tolerance of the oral nutritional supplement on a single occasion with respect to a continuous intake over a period of 4 weeks.
- Evaluate the impact of oral nutritional supplementation on nutritional status over a four-week period.
- Evaluate the impact of oral nutritional supplementation on the functional capacity of the patient in a period of four weeks.
- Evaluate the impact of oral nutritional supplementation on the patient's body composition over a four-week period.
- Evaluate the impact of oral nutritional supplementation on the quality of life of the patient in a period of four weeks.
- Evaluate the impact of oral nutritional supplementation on the depressive and anxious symptoms of the patient in a period of four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants, ≥ 12 y ≤ 40 years of age at screening
- •Diagnosed of Anorexy nervous according to DSM-5
- •Appropiate cultural level & understanding of the clinical study
- •To be in agreement in participate voluntarily in the study and written informed consent must be obtained from the participants.
- •Females who are non-pregnant and non-lactating women or women who have given birth at least six weeks before to the screening visit.
排除标准
- •Allergy or intolerance to any component of the products under study.
- •Participation in a concomitant trial that conflicts with this study
- •Doesn't sign the informed consent
结局指标
主要结局
Compare the digestive tolerance of an oligomeric nutritional supplement with respect to a polymeric nutritional supplement in a group of patients diagnosed with anorexia nervosa under follow-up by the Nutrition Unit.
时间窗: From baseline to week 1
Differences in the score of the questionnaire: "Evaluation questionnaire for gastrointestinal complaints". This questionnaire assesses the presence (and where appropriate its degree) or absence of nausea, vomiting, diarrhea, constipation, reflux or heartburn. Each section has a score from 0 to 10, which will be filled in by the patient himself.
次要结局
- Changes in eating habits and styles(From baselilne to week 8)
- Assess the impact of oral nutritional supplementation on the patient's depressive and anxious symptoms.(From baseline to week 8)
- Assess the gastrointestinal tolerance of the oral nutritional supplement on a single occasion with respect to a continuous intake over a period of 4 weeks.(From baseline to week 1 in group 1; from baseline to week 8 in group 2)
- Compare the sensory perception of a polymeric nutritional supplement with respect to an oligomeric one.(From baseline to week 1 in group 1; from baseline to week 8 in group 2)
- Compare adherence to treatment in group 2 subjects.(From baseline to week 8 in group 2)
- Evaluate the intake of natural food in group 2 patients.(From baseline to week 8 in group 2)
- Changes in weight(From baseline to week 8)
- Change in hand grip strength(From baselilne to week 8)
- Change in fat mass(From baselilne to week 8)
- Change in lean mass(From baselilne to week 8)
- Change in extracellular water(From baselilne to week 8)
- Change in intracellular water(From baselilne to week 8)
- Change in phase angle(From baselilne to week 8)
- Change in total cell mass(From baselilne to week 8)
- Evaluate the impact of oral nutritional supplementation on the quality of life of the patient(From baselilne to week 8)