Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Malnutrition, Cancer, Inflammatory Bowel Diseases
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Hospital Universitario de BasurtoRecruiting
- Hospital Universitario Reina SofíaRecruiting
- Hospital Universitario de Gran Canaria Doctor NegrínRecruiting
- Hospital Universitario de MóstolesRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Clínico ValladolidRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Fortimel Energy
Fortimel PlantBased
Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days
Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days