Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Change in weight
研究概览
简要总结
This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria.
详细描述
Due to the increasingly pressing need to develop an oral nutritional supplement (ONS) that does not contain animal ingredients, Fortimel PlantBased, suitable for patients with Disease-Related Malnutrition or who wish to avoid or reduce the consumption of animal products for dietary or lifestyle reasons, is being promoted. At the same time, it is also a therapeutic option to be considered in the population with allergy or intolerance to cow's milk protein. Therefore, the aim is to offer an adapted therapeutic nutritional solution that guarantees nutritional results that are not inferior than ONS with animal protein (cow's milk protein).
This study was designed as an open-label randomized controlled non-inferiority trial with two arms: a new planted-based ONS (Fortimel PlantBased) as the intervention arm and standard ONS (Fortimel Energy) as the control arm, both high-energy formulas (1.5 kcal/m; 200ml).
The study will be carried out in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria, who need to supplement their diet by taking a high-energy ONS for at least 12 weeks. These patients will be treated and follow-up by the Endocrinology and Nutrition services of 6 public hospitals in Spain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Malnourished patients according to GLIM criteria
- •Patients with a high energy requirement (1.5kcal/ml) requiring the intake of 2 bottles of ONS per day for at least 12 weeks
- •Patients presenting any of the following clinical situations:
- •Elderly patients requiring oral nutritional support
- •Patients with digestive pathology including but not restricted to inflammatory bowel disease, short bowel syndrome, pancreatitis, without active malabsorption and maldigestion.
- •Chronic diseases such as COPD, mild to moderate renal disease, HIV
- •Oncologic patients with Eastern Cooperative Oncology Group (ECOG) 0-1
- •Patients who have given their consent to participate
- •Patients who, in the opinion of the physician, have the capacity to answer the study questionnaires themselves or their caregivers
排除标准
- •Patients who need ONS due to surgical or acute illness*
- •Patients with known intolerance or allergy to cow's milk, soya or peas
- •Patients with hyperthyroidism. Patients with uncontrolled hypothyroidism
- •Uncontrolled diabetic patients (HbA1c >8%)
- •Patients requiring enteral nutrition by tube or ostomy
- •Patients with moderate and serious renal insufficiency < 30ml/min/1,73 m2
- •Patients who have value creatinine:
- •1,70 mg/dl - 150,31umol/L Men
- •1,50 mg/dl - 132,63umol/L Women
- •Patients with levels of haemoglobin <10 g/dl, transferrin <150 mg /dl
研究组 & 干预措施
Fortimel Energy
Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days
干预措施: Fortimel (Dietary Supplement)
Fortimel PlantBased
Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days
干预措施: Fortimel (Dietary Supplement)
结局指标
主要结局
Change in weight
时间窗: Changes between baseline and final visit (12 weeks).
Change in weight percentage
Improvement in nutritional status
时间窗: From the baseline to the final visit (12 weeks)
Improvement in nutritional status according to the GLIM criteria. A change in classification category from grade 2 of malnutrition to grade 1 or not meet GLIM criteria, as well as a change from grade 1 to not meet GLIM criteria are considered an improvement.
次要结局
- Change in calf circumference(From baseline to final visit (12 week))
- Percentage of compliance(During the study follow up)
- ONS Satisfaction(Final visit (12 week))
- Change in muscle strength(From the baseline to final visit (12 weeks))
- Changes in the gastrointestinal symptom scale (GSRS)(From the baseline to final visit (12 week))