Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055543
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-09-14
Brief Title:
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Sponsor:
Danone Specialized Nutrition
Organization:
Danone Specialized Nutrition
Study Overview
Official Title:
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 cows 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 cows 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 cows 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 15 kcalm 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
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 15 kcalm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None