Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement
Malnutrition
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years Patients who are in one of the following clinical situations: oncological patients who did not undergo surgery during the month prior to inclusion, including head and neck, esophagus, stomach, pancreas, or colon cancer; surgical patients who underwent surgery less than one month, including all types of surgical processes; and other non-surgical patients diagnosed with benign esophageal stricture, chronic radiation enteritis, and non-oncological maxillofacial pathology, cystic fibrosis, human immunodeficiency virus (HIV), malabsorption syndrome , ulcerative colitis, Crohn's disease, fistula, intestinal pseudo-obstruction, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), or who were undergone to scheduled major surgery or transplantation within a period of no less than 2 months until inclusion. Patients with malnutrition or at risk of malnutrition according to Subjective Global Assessment (SGA). Patients with a high energy requirement that require 2 bottles/day of an ONS (≥2kcal/ml), for a minimum period of 8 weeks Patients who have not received ONS during the month prior to their inclusion. Surgical patients may have received ONS prior to the study in accordance with the guidelines of the institution. Patients who voluntarily agree to participate in the study and give their signed consent for participation. Exclusion Criteria: Patients suffering from any of the following clinical disorders: chronic kidney insufficiency or diabetes. Patients requiring enteral tube feeding or parenteral nutrition. Patients suffering from an allergy or intolerance to the product ingredients. Patients scheduled for surgery during the study period. Patients who, in the opinion of the treating physician, are unable to adhere to the protocol instructions, including inability of the patient/caregiver to use the study eCRF, and to remain in the study during all the follow-up.
Sites / Locations
- Hospital Universitario 12 de Octubre
- Hospital Regional Universitario de Málaga
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS
Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS
Intervention: high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days followed by high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days
Intervention: high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days followed by high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days