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Introduction of an Enriched Evening Meal on the Feeding Behavior of Institutionalized Residents

Impact of the Introduction of a New Qualitative Composition of the Evening Meal on the Feeding Behavior of Institutionalized Residents of a Long-term Care Unit: a Randomized, Single Center Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02329613
Acronym
IRCAR
Enrollment
48
Registered
2014-12-31
Start date
2015-04-30
Completion date
2015-12-31
Last updated
2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Institutionalization

Brief summary

The main objective of this study was to evaluate and compare 6-month calorie intakes between a group of patients receiving a standard dinner and a group of patients whose evening meal is improved; compliance will be assessed on a food card with 5 levels of consumption: no (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per month for 6 months and will, from the total calorie intake of each dish, estimate calorie intake ingested per day on all meals of the day.

Detailed description

The secondary objectives of this study are to evaluate the two groups for the following: A. The difference between 0 and 6 months in: the patient's weight, calorie intake, serum prealbumin, albumin and CRP, blood sugar for diabetic patients. B. Monthly evolution over 6 months: calorie intake, the patient's weight. C. The quarterly trend over 6 months: serum prealbumin, albumin and CRP, blood sugar for diabetic patients. D. Comorbidities and mortality. E. the risk of morning hypoglycaemia for diabetic patients.

Interventions

OTHERStandard evening meals.

Patients will receive usual evening meals.

OTHERImproved evening meal

Patients will receive improved evening meals. Improved meals will include enriched soup (with starches, butter, cheese or sour cream), a semi-liquid dairy dessert, fruit or a fruit dessert.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The subject or his/her representative must be given free and informed consent and must have signed the consent * The subject must be affiliated with or beneficiary of a health insurance plan * The subject has lived for at least 3 months in the institution * The subject is fed by mouth only

Exclusion criteria

* The subject is participating in another study * The subject is in an exclusion period determined by a previous study * The subject or his/her legal representative refuses to sign the consent * It is not possible to correctly inform the subject or his/her representative

Design outcomes

Primary

MeasureTime frame
Total caloric ration for each dish6 months
Meal compliance for 3 days6 months
Ingested caloric intake6 months

Secondary

MeasureTime frame
Weight (kg)Baseline (days -7 to 0)
Serum prealbuminBaseline (days -7 to 0)
Serum albuminBaseline (days -7 to 0)
Serum C reactive proteinBaseline (days -7 to 0)
Total caloric ration for each dishBaseline (days -7 to 0)
Presence/absence of comorbiditiesMonth 6
MortalityMonth 6
Capillary fasting blood glucose for diabetic patientsMonth 1
Glycated hemoglobin (HbA1C) for diabetic patientsBaseline (days -7 to 0)
Meal compliance for 3 daysBaseline (days -7 to 0)
Ingested caloric intakeBaseline (days -7 to 0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026