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CompletedNCT05609006Updated Nov 8, 2022

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

An interventional study of High-Energy, Low-Volume ONS and High-Energy Standard ONS in Malnutrition, sponsored by Danone Specialized Nutrition. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Danone Specialized Nutrition (part of Danone) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jul 2019, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Malnutrition

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03

In context

Malnutrition

1,619 studies on the registry are indexed under Malnutrition; 241 are open to participants now.

This study's enrollment of 73 is below the median of 90 across 1,152 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Danone Specialized Nutrition is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Browse Danone Specialized Nutrition studies →All Danone studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • 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

    Dietary Supplement: High-Energy, Low-Volume ONS · Dietary Supplement: High-Energy Standard ONS

  • 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

    Dietary Supplement: High-Energy, Low-Volume ONS · Dietary Supplement: High-Energy Standard ONS

Interventions

  • Dietary supplementHigh-Energy, Low-Volume ONS

    2 bottles/day of a High-Energy, Low-Volume ONS

    Also known as: Energy-dense ONS, 2.4 ONS

  • Dietary supplementHigh-Energy Standard ONS

    2 bottles/day of a High-Energy Standard ONS

    Also known as: 2.0 ONS

06

What researchers measure

Primary outcomes

  1. Compliance rate with ONS

    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 outcomes

  1. 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.

    Time frame: Weekly (from second to fourth week of each period) up to 8 weeks

  2. 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).

    Time frame: For each period/ONS, up to 8 weeks

07

Study locations

2 sites
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Regional Universitario de Málaga
    Málaga, 29001, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Dec 2021, 29 months.

Of 31 industry-sponsored interventional studies with no phase under Malnutrition, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 29 months is above that.

Counting every sponsor, half of 469 studies reached it within 20 months; a quarter within 10 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2022
First posted
Nov 8, 2022
StartActual
Jul 1, 2019
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
Nov 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05609006
Lead sponsor
Danone Specialized Nutrition
Responsible party
Sponsor
First posted
Nov 8, 2022
Start date
Jul 1, 2019
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Nov 8, 2022

Study contacts

Miguel Leon, MD
principal investigator · Hospital Universitario 12 de Octubre
Gabriel Olveira, MD
principal investigator · Hospital Regional de Malaga

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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