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Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Fortimel

Natalia Iglesias, MD

Alfonso Calañas, MD

Pedro L Pablos Velasco, MD

Araceli Ramos, MD

Pedro Pablo Garcia Luna, MD

Daniel Antonio De Luis Román, MD

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.

Due to the increasingly pressing need to develop an oral nutritional supplement (ONS) that does not contain animal ingredients, Fortimel PlantBased, suitable for patients with Disease-Related Malnutrition or who wish to avoid or reduce the consumption of animal products for dietary or lifestyle reasons, is being promoted. At the same time, it is also a therapeutic option to be considered in the population with allergy or intolerance to cow's milk protein. Therefore, the aim is to offer an adapted therapeutic nutritional solution that guarantees nutritional results that are not inferior than ONS with animal protein (cow's milk protein).

This study was designed as an open-label randomized controlled non-inferiority trial with two arms: a new planted-based ONS (Fortimel PlantBased) as the intervention arm and standard ONS (Fortimel Energy) as the control arm, both high-energy formulas (1.5 kcal/m; 200ml).

The study will be carried out in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria, who need to supplement their diet by taking a high-energy ONS for at least 12 weeks. These patients will be treated and follow-up by the Endocrinology and Nutrition services of 6 public hospitals in Spain.

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

Improvement in nutritional status according to the GLIM criteria. A change in classification category from grade 2 of malnutrition to grade 1 or not meet GLIM criteria, as well as a change from grade 1 to not meet GLIM criteria are considered an improvement.

Taking into account the number of bottles per day taken, the ml of product and the ml left over.

Patients satisfaction taking ONS will be considered if a patient indicates a score of at least 8 points for overall satisfaction question.

Danone Specialized Nutrition

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients	NCT06055543	Malnutrition Cancer Inflammatory Bo... Chronic Obstruc... Hiv	Fortimel	18 Years -	Danone Specialized Nutrition
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients	NCT06055543	Malnutrition Cancer Inflammatory Bo... Chronic Obstruc... Hiv	Fortimel	18 Years -	Danone Specialized Nutrition

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Spots Global Cancer Trial Database for fortimel

Every month we try and update this database with for fortimel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fortimel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.