Evidence map›Paper›PMID 41356829›Full record

Trial reportFrontiers in nutrition2025

Effect of a new plant-based high-energy oral nutritional supplement in adult malnourished patients: an open-label, randomized clinical trial.

Natalia Covadonga Iglesias Hernández, Araceli Ramos Carrasco, Daniel Antonio De Luis Román, Pedro Luis de Pablos-Velasco, Alfonso Calañas Continente, Miren Josune Rodríguez Soto, Juan José López-Gómez, Cristina Comi-Díaz, Silvia García-Rey, Clara Pérez-Rambla and 1 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Frontiers in nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06055543 (Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06055543 phase4unknown statusnot on this map

Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients

TypeinterventionalSponsorDanone Specialized NutritionRan2023 to 2024Enrolled140ConditionsMalnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD)ArmsFortimel
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Natalia Covadonga Iglesias HernándezEndocrinology and Nutrition Department, Basurto University Hospital, Bilbao, Spain.
Araceli Ramos CarrascoEndocrinology and Nutrition Department, Mostoles University Hospital, Madrid, Spain.
Daniel Antonio De Luis RománUniversity of Valladolid, Valladolid, Spain.
Pedro Luis de Pablos-VelascoEndocrinology and Nutrition Department, University of Las Palmas de Gran Canaria, Gran Canaria, Spain.
Alfonso Calañas ContinenteEndocrinology and Nutrition Department, Reina Sofía University Hospital, Córdoba, Spain.
Miren Josune Rodríguez SotoEndocrinology and Nutrition Department, Basurto University Hospital, Bilbao, Spain.
Juan José López-GómezEndocrinology and Nutrition Department, Valladolid University Clinical Hospital, Health Research Institute of Valladolid (IBioVALL) and Center of Investigation Endocrinology and Nutrition, University of Valladolid, Valladolid, Spain.
Cristina Comi-DíazEndocrinology and Nutrition Department, University of Las Palmas de Gran Canaria, Gran Canaria, Spain.
Silvia García-ReyNutrition Unit, Endocrinology and Nutrition Department, Virgen del Rocío University Hospital, Sevilla, Spain.
Clara Pérez-RamblaRWE Department, Outcomes'10 SLU, Castellón de la Plana, Spain.
Pedro Pablo García-LunaNutrition Unit, Endocrinology and Nutrition Department, Virgen del Rocío University Hospital, Sevilla, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and aims: The recent global trend toward reducing the consumption of animal-derived products has contributed to a growing demand for plant-based oral nutritional supplement (pbONS) options. PbONS, in addition to achieving good compliance, have an improvement in nutritional status (increased energy and protein intake, body weight, and BMI) on malnourished patients. However, there is no evidence of their impact compared to animal-based ONS (aONS). Methods: A multicenter, open-label, and non-inferiority trial (NCT06055543) was conducted in 5 tertiary hospitals in Spain. Adult malnourished outpatients requiring high-energy ONS for at least 12 weeks (1.5 kcal/ml;200 ml, 2 bottles/day), having signed informed consent, were recruited and randomly assigned (1:1) to receive pbONS or aONS. Randomization was performed using a pre-generated list embedded in the electronic data entry platform. The total number of participants randomized was 149, 75 patients in aONS group and 74 in pONS group. Baseline and final characteristics of the two groups were described and compared in terms of sociodemographic, clinical, compliance, and satisfaction variables. Results: A total of 129 patients who received pbONS (66) or aONS (74) were included. Weight increased significantly from 55.1 ± 12.7 kg to 57.4 ± 13.1 kg ( Conclusion: PbONS are as effective and well-tolerated as traditional ONS in improving nutritional outcomes, with high patient satisfaction in malnourished patients. This study provides valuable evidence for integrating pbONS into routine clinical practice for the tailored management of patients. Clinical trial registration: The study was registered on September 21, 2024, with the identifier number NCT06055543.

Indexed as

gastrointestinal tolerancemalnourished patientsnutritional statusoral nutritional supplementplant-based diet

Identifiers

PMID41356829
PMCPMC12677066

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.