Clinical Trials Directory

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UnknownNCT06055543

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Danone Specialized Nutrition · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTFortimel2 bottles/day of the high energy ONS

Timeline

Start date
2023-08-09
Primary completion
2024-05-31
Completion
2024-05-31
First posted
2023-09-26
Last updated
2023-09-26

Locations

6 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT06055543. Inclusion in this directory is not an endorsement.