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

Malnutrition Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857049
• Other study ID #: 2013-03
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2016
• Last updated: August 2, 2016
• Start date: February 2014

Study information

• Verified date: July 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Florence ROSSI- PACINI
• Phone: 04.91.38.14.30
• Email: florence.rossi-pacini[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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:

• 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Geriatric Patients
• Malnutrition

Intervention

Other:
• Oral nutritional supplements (ONS) degustation

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the consumed quantity of ONS in weight percentage		3 months	No
Primary	Assessment of the consumed quantity of ONS in weight percentage		3 months after hospital's discharge	No