Clinical trial · Interventional
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
NCT06055543CI-TRIAL-00069947unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Obstructive Pulmonary Disease (COPD) | — | UNRESOLVED | — |
| Hiv | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fortimel | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fortimel Energy
- description
- Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days
- interventionNames
- Dietary Supplement: Fortimel
- type
- EXPERIMENTAL
- label
- Fortimel PlantBased
- description
- Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days
- interventionNames
- Dietary Supplement: Fortimel
Primary outcomes (2)
- measure
- Change in weight
- timeFrame
- Changes between baseline and final visit (12 weeks).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 /dlReferences
Publications (1)
- DERIVEDIglesias Hernandez NC, Ramos Carrasco A, De Luis Roman DA, de Pablos-Velasco PL, Calanas Continente A, Rodriguez Soto MJ, Lopez-Gomez JJ, Comi-Diaz C, Garcia-Rey S, Perez-Rambla C, Garcia-Luna PP. Effect of a new plant-based high-energy oral nutritional supplement in adult malnourished patients: an open-label, randomized clinical trial. Front Nutr. 2025 Nov 20;12:1667954. doi: 10.3389/fnut.2025.1667954. eCollection 2025. PMID 41356829