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Status unknownNCT02857049Updated Aug 5, 2016

Effective Consumption of Oral Nutritional Supplements in Geriatrics: A Study Evaluating a Strategy Based on a Preliminary Degustation

An interventional study of Oral nutritional supplements (ONS) degustation in Malnutrition and Geriatric Patients, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Not applicable
Ages
70 Years and older
Sex
All
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Study summary

Malnutrition affects until 70% of the patients hospitalized in geriatric's units and constitutes an independent risk factor of morbidity and mortality. Malnutrition is also associated with increased length of stay and increased costs, and alters the quality of life. Oral nutritional supplements (ONS) play a key role in the prevention and treatment of malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional supply with a high density of calorie and protein. The clinical efficiency of ONS is well demonstrated whether on nutritional parameters or on clinical outcomes. However, acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50% to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia, taste changes, monotony ... also partly because patients dislike flavor, taste or texture. The respect of patients' preferences is essential to improve the therapeutic observance to ONS. Generally, ONS are delivered after the patient has told his preferences orally to the dietitian. To date, there is no study evaluating the effect of an alternative strategy based on a preliminary degustation of several products on the effective consumption of ONS in geriatrics.

The study is designed as prospective, randomized, controlled, open study to test this strategy in older undernourished people hospitalized in geriatrics who require prescription of ONS. This study will be performed among 220 older people hospitalized in two departments of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).

The main objective is to compare the therapeutic observance to ONS when products are delivered to older people according to the usual way (preferences announced orally and/or dietitian's choice) or according to an alternative strategy based on a preliminary degustation of several products varying for flavor and texture but always in respect of the medical prescription. The secondary objective is to compare the evolution of the nutritional status estimated by routinely used clinical and biological parameters, as well as the main clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients will be reevaluated clinically 3 months after the hospital's discharge.

The hypothesis is that a strategy based on a preliminary degustation, leading to an informed choice, will significantly improve the acceptability and the effective consumption of ONS during the hospital stay, and will also impact positively the nutritional status at hospital's discharge and 3 months after. The validation of this hypothesis could allow recommending the generalization of preliminary degustation of ONS at the time of their prescription to optimize the therapeutic observance in undernourished older people.

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Conditions studied

  • Malnutrition
  • Geriatric Patients

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 220 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  • Patient aged over 70 years, hospitalized in a geriatric service for a short stay
  • Patient malnourished or at risk of malnutrition, justifying the medical prescription of ONS
  • Patient agreeing to participate in the study and who signed the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Patient particularly protected (adult and incapable person deprived of liberty)
  • Patient with a disease making it impossible to administer oral feeding
  • Patient for which it is impossible to gather enough reliable data interrogation (dementia, pre-dementia, lack of proficiency in the French language)
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Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Geriatric patients administered with ONS

    Oral nutritional supplements (ONS) degustation

    Other: Oral nutritional supplements (ONS) degustation

Interventions

  • OtherOral nutritional supplements (ONS) degustation
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What researchers measure

Primary outcomes

  1. Assessment of the consumed quantity of ONS in weight percentage

    Time frame: 3 months

  2. Assessment of the consumed quantity of ONS in weight percentage

    Time frame: 3 months after hospital's discharge

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Study locations

1 of 1 sites recruiting
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13354 Cedex 05, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02857049
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
Feb 2014
Primary completion
Feb 2017 (estimated)
Last update
Aug 5, 2016

Study contacts

Florence ROSSI- PACINI
Contact
florence.rossi-pacini@ap-hm.fr
04.91.38.14.30
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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