- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609006
Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement
Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement (ONS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28041
- Hospital Universitario 12 De Octubre
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Málaga, Spain, 29001
- Hospital Regional Universitario de Málaga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS
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
|
2 bottles/day of a High-Energy, Low-Volume ONS
Other Names:
2 bottles/day of a High-Energy Standard ONS
Other Names:
|
Experimental: Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS
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
|
2 bottles/day of a High-Energy, Low-Volume ONS
Other Names:
2 bottles/day of a High-Energy Standard ONS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance rate with ONS
Time Frame: One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)
|
Percentage of consumed energy over the prescribed
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One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal tolerance
Time Frame: Weekly (from second to fourth week of each period) up to 8 weeks
|
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.
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Weekly (from second to fourth week of each period) up to 8 weeks
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Satisfaction with ONS
Time Frame: For each period/ONS, up to 8 weeks
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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).
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For each period/ONS, up to 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miguel Leon, MD, Hospital Universitario 12 De Octubre
- Principal Investigator: Gabriel Olveira, MD, Hospital Regional de Málaga
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUT 2.4 Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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