Completed

High-Energy, Low-Volume Oral Nutritional Supplement Compliance in Malnourished Patients

What is being tested

High-Energy, Low-Volume ONS

+ High-Energy Standard ONS

Dietary Supplement

Who is being recruted

Nutrition Disorders

+ Nutritional and Metabolic Diseases

+ Malnutrition

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2019

See protocol details

Summary

Principal SponsorDanone Specialized Nutrition

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2019

Actual date on which the first participant was enrolled.

This study focuses on improving the nutritional status of adults who are either malnourished or at risk of malnutrition, specifically those diagnosed with cancer, surgical patients, and others. The goal is to compare the effectiveness of two types of oral nutritional supplements (ONS): a high-energy, low volume ONS and a standard high-calorie, high-volume ONS. The study aims to understand if a more energy-dense and less voluminous supplement can help patients meet their nutritional needs better, as this could potentially improve their health outcomes and quality of life. During this 8-week study, participants are randomly assigned to one of two groups. Group A receives the high-energy, low volume ONS for 28 days, followed by the standard ONS for 7 days. Group B starts with the standard ONS for 28 days, then switches to the high-energy, low volume ONS for 28 days. The primary outcome measured is the compliance rate, or the percentage of energy consumed compared to what was prescribed. Additionally, the study evaluates the supplements' gastrointestinal tolerance and patient satisfaction, as well as identifying factors that may influence compliance. The cost associated with product wastage for both ONS is also compared.

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

NCT05609006

Principal SponsorDanone Specialized Nutrition

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

73 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nutrition DisordersNutritional and Metabolic DiseasesMalnutrition

Criteria

6 inclusion criteria required to participate

Patients ≥ 18 years

Patients who are in one of the following clinical situations: oncological patients who did not undergo surgery during the month prior to inclusion, including head and neck, esophagus, stomach, pancreas, or colon cancer; surgical patients who underwent surgery less than one month, including all types of surgical processes; and other non-surgical patients diagnosed with benign esophageal stricture, chronic radiation enteritis, and non-oncological maxillofacial pathology, cystic fibrosis, human immunodeficiency virus (HIV), malabsorption syndrome , ulcerative colitis, Crohn's disease, fistula, intestinal pseudo-obstruction, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), or who were undergone to scheduled major surgery or transplantation within a period of no less than 2 months until inclusion.

Patients with malnutrition or at risk of malnutrition according to Subjective Global Assessment (SGA).

Patients with a high energy requirement that require 2 bottles/day of an ONS (≥2kcal/ml), for a minimum period of 8 weeks

Show More Criteria

5 exclusion criteria prevent from participating

Patients suffering from any of the following clinical disorders: chronic kidney insufficiency or diabetes.

Patients requiring enteral tube feeding or parenteral nutrition.

Patients suffering from an allergy or intolerance to the product ingredients.

Patients scheduled for surgery during the study period.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Intervention: high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days followed by high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days

Group II

Experimental

Intervention: high-energy standard ONS (2.0kcal/ml; 200ml) for 28 days followed by high-energy low-volume ONS (2.4kcal/ml; 125ml) for 28 days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Hospital Universitario 12 de Octubre

Madrid, SpainOpen Hospital Universitario 12 de Octubre in Google Maps

Suspended

Hospital Regional Universitario de Málaga

Málaga, Spain

Completed2 Study Centers