MalnutritionNCT05609006
Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement
A study testing High-Energy, Low-Volume ONS and High-Energy Standard ONS in people with Malnutrition, run by Danone Specialized Nutrition at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- High-Energy, Low-Volume ONS and High-Energy Standard ONS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario de Málaga
Málaga, 29001
About this study
Official title: Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement (ONS)
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.
Read the 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
- Being tested
- High-Energy, Low-Volume ONS, High-Energy Standard ONS
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Energy, Low-Volume ONSDietary supplement
Also called Energy-dense ONS, 2.4 ONS
2 bottles/day of a High-Energy, Low-Volume ONS
High-Energy Standard ONSDietary supplement
Also called 2.0 ONS
2 bottles/day of a High-Energy Standard ONS
| Study group | Role | What they receive |
|---|---|---|
| Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS | 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 Receives: Dietary Supplement: High-Energy, Low-Volume ONS; Dietary Supplement: High-Energy Standard ONS |
| Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS | 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 Receives: Dietary Supplement: High-Energy, Low-Volume ONS; Dietary Supplement: High-Energy Standard ONS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate with ONS
Percentage of consumed energy over the prescribed
Measured: One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)
Secondary outcomes (2)
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.
Measured: Weekly (from second to fourth week of each period) up to 8 weeks
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).
Measured: For each period/ONS, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Specialized Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Leon, MD, Principal investigator, Hospital Universitario 12 de OctubreGabriel Olveira, MD, Principal investigator, Hospital Regional de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609006
- Sponsor's protocol ID
- NUT 2.4 Study
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With a High Energy Content, Low Volume Oral Nutritional Supplement (ONS)
- ClinicalTrials.gov ID
- NCT05609006
- Acronym / sponsor ID
- NUT 2.4 Study
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Danone Specialized NutritionIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS | Experimental | Dietary Supplement: High-Energy, Low-Volume ONS, Dietary Supplement: High-Energy Standard ONSIntervention: 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 B: High-Energy Standard ONS // High-Energy, Low-Volume ONS | Experimental | Dietary Supplement: High-Energy, Low-Volume ONS, Dietary Supplement: High-Energy Standard ONSIntervention: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Energy, Low-Volume ONSAlso: Energy-dense ONS, 2.4 ONS2 bottles/day of a High-Energy, Low-Volume ONS | Dietary supplement | Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS, Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS |
| High-Energy Standard ONSAlso: 2.0 ONS2 bottles/day of a High-Energy Standard ONS | Dietary supplement | Group A: High-Energy, Low-Volume ONS // High-Energy Standard ONS, Group B: High-Energy Standard ONS // High-Energy, Low-Volume ONS |
Primary outcome
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
2 secondary outcomes
Gastrointestinal tolerance
Time frame: Weekly (from second to fourth week of each period) up to 8 weeks
Satisfaction with ONS
Time frame: For each period/ONS, up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Leon, MD principal investigator
Hospital Universitario 12 de Octubre
Gabriel Olveira, MD principal investigator
Hospital Regional de Malaga
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Energy, Low-Volume ONS and High-Energy Standard ONS in people with Malnutrition, run by Danone Specialized Nutrition at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate with ONS (time frame: One period of 28 days for both ONS (high-energy low-volume, and high-energy standard)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.