Last reviewed · How we verify
NCT06055543
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Phase 4 trial testing Fortimel in Malnutrition in 140 participants. Status unknown.
31 May 2024
Quick facts
| Lead sponsor | Danone Specialized Nutrition |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 9 August 2023 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 May 2024 |
| Sites | 6 locations across Spain |
Drugs / interventions tested
- Fortimel
Conditions studied
- Malnutrition — all drugs for Malnutrition →
- Cancer — all drugs for Cancer →
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →
Sponsor
Danone Specialized Nutrition
Who can join
18 and older, any sex, with Malnutrition or Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of a new plant-based high-energy oral nutritional supplement in adult malnourished patients: an open-label, randomized clinical trial.
Iglesias Hernández NC, Ramos Carrasco A, De Luis Román DA, de Pablos-Velasco PL, et al · · 2025 · PMID 41356829 · DOI 10.3389/fnut.2025.1667954
Verify or expand the search:
- PubMed search for NCT06055543
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fortimel
Trials testing the same drug.
- NCT06698783 — Practical Application and Evaluation of Fortimel in Oncology Patients · NA · not yet recruiting
Other recruiting trials for Malnutrition
Currently open trials in the same condition.
- NCT07162701 — Body Composition Assessment and Monitoring in Inflammatory Bowel Disease · recruiting
- NCT05324475 — Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition. · NA · recruiting
- NCT06825377 — Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrom · NA · recruiting
- NCT06687291 — Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer · recruiting
- NCT06837194 — Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis · recruiting
Other Danone Specialized Nutrition trials
Trials by the same sponsor.
- NCT05609006 — Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06055543 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danone Specialized Nutrition
- Last refreshed: 26 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06055543.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing