NCT05609006

Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement

Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement (ONS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Danone Specialized Nutrition · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the compliance of high-energy, low-volume oral nutritional supplements (ONS) compared to equivalent high-energy standard ONS (control) in participants at risk of malnutrition.

Detailed description

The use of high-calorie, high-protein ONS is recommended in patients with malnutrition or who are at risk of malnutrition-related disease. However, compliance with ONS is a key feature to improve the patient's nutritional status. Since compliance with ONS could be influenced by the energy density and the volume of the nutritional supplement used, a higher energy density and lower volume ONS could provide similar energy to the standard ONS for the requirements of this population. This study has been designed as an open-label randomized crossover study with nutritional intervention with the aim to compare the patient's compliance, defined as the percentage of energy consumed with respect to that prescribed, with a high-energy content, low volume ONS versus a standard high calorie and volume ONS, over an 8-weeks follow-up period. As secondary objectives, the study aims to describe the gastrointestinal tolerance and satisfaction of the study ONS, to establish the factors that may affect compliance with the ONS and to compare the cost associated with product wastage in both ONS. The study population will consist of patients aged ≥ 18 years, distributed into three groups according to their diagnosis: oncological patients, surgical patients, and other patients, all of them malnourished or at risk of malnutrition according to Subjective Global Assessment (SGA), and requiring the use of an ONS. Participants will be randomly allocated to receive either: Group A: A high energy, low volume ONS (2.4kcal/ml; 125ml) in addition to the diet for 28 days. Participants will then receive the equivalent standard ONS (2.0kcal/ml, 200ml) as control ad libitum in addition to diet for 7 days, or: Group B. A standard ONS (2.0 kcal/ml, 200ml) as control in addition to the diet for 28 days. Participants will then receive the high energy, low volume equivalent ONS (2.4kcal/ml; 125ml) for 28 days.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High-Energy, Low-Volume ONS	2 bottles/day of a High-Energy, Low-Volume ONS
DIETARY_SUPPLEMENT	High-Energy Standard ONS	2 bottles/day of a High-Energy Standard ONS

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-11-08
• Last updated: 2022-11-08

Locations

2 sites across 1 country: Spain