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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High-Energy, Low-Volume ONS
High-Energy Standard ONS
Sponsored by
Danone Specialized Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Patients who have not received ONS during the month prior to their inclusion. Surgical patients may have received ONS prior to the study in accordance with the guidelines of the institution. Patients who voluntarily agree to participate in the study and give their signed consent for participation. Exclusion Criteria: 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. Patients who, in the opinion of the treating physician, are unable to adhere to the protocol instructions, including inability of the patient/caregiver to use the study eCRF, and to remain in the study during all the follow-up.

Sites / Locations

  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario de Málaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS

Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Compliance rate with ONS
Percentage of consumed energy over the prescribed

Secondary Outcome Measures

Gastrointestinal tolerance
Tolerance is measured using a numeric rate scale (NRS) of the frequency of symptoms (0, not at all; 10, very frequently) for the last 7 days such as nausea, vomiting, diarrhea, constipation, acid reflux, bellyache, bloated belly, stomach pain, flatulence, and satiety.
Satisfaction with ONS
Satisfaction with the ONS taste, satiety, ease of completing the intake, and overall satisfaction are measured using an NRS of the level of satisfaction (0, very dissatisfied; 10, very satisfied).

Full Information

First Posted
October 31, 2022
Last Updated
November 4, 2022
Sponsor
Danone Specialized Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT05609006
Brief Title
Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement
Official Title
Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement (ONS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Specialized Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS
Arm Type
Experimental
Arm Description
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
Arm Title
Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
High-Energy, Low-Volume ONS
Other Intervention Name(s)
Energy-dense ONS, 2.4 ONS
Intervention Description
2 bottles/day of a High-Energy, Low-Volume ONS
Intervention Type
Dietary Supplement
Intervention Name(s)
High-Energy Standard ONS
Other Intervention Name(s)
2.0 ONS
Intervention Description
2 bottles/day of a High-Energy Standard ONS
Primary Outcome Measure Information:
Title
Compliance rate with ONS
Description
Percentage of consumed energy over the prescribed
Time Frame
One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)
Secondary Outcome Measure Information:
Title
Gastrointestinal tolerance
Description
Tolerance is measured using a numeric rate scale (NRS) of the frequency of symptoms (0, not at all; 10, very frequently) for the last 7 days such as nausea, vomiting, diarrhea, constipation, acid reflux, bellyache, bloated belly, stomach pain, flatulence, and satiety.
Time Frame
Weekly (from second to fourth week of each period) up to 8 weeks
Title
Satisfaction with ONS
Description
Satisfaction with the ONS taste, satiety, ease of completing the intake, and overall satisfaction are measured using an NRS of the level of satisfaction (0, very dissatisfied; 10, very satisfied).
Time Frame
For each period/ONS, up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Patients who have not received ONS during the month prior to their inclusion. Surgical patients may have received ONS prior to the study in accordance with the guidelines of the institution. Patients who voluntarily agree to participate in the study and give their signed consent for participation. Exclusion Criteria: 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. Patients who, in the opinion of the treating physician, are unable to adhere to the protocol instructions, including inability of the patient/caregiver to use the study eCRF, and to remain in the study during all the follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Leon, MD
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira, MD
Organizational Affiliation
Hospital Regional de Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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