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

Institutionalization Clinical Trial

— IRCAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329613
• Other study ID #: LOCAL/2014/BH-01
• Secondary ID: 2014-A00509-38
• Status: Completed
• Phase: N/A
• First received: December 29, 2014
• Last updated: May 23, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Institutionalization

Intervention

Other:
• Standard evening meals.
Patients will receive usual evening meals.
• Improved 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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total caloric ration for each dish		6 months	No
Primary	Meal compliance for 3 days		6 months	No
Primary	Ingested caloric intake		6 months	No
Secondary	Total caloric ration for each dish		Baseline (days -7 to 0)	No
Secondary	Total caloric ration for each dish		Month 1	No
Secondary	Total caloric ration for each dish		Month 2	No
Secondary	Total caloric ration for each dish		Month 3	No
Secondary	Total caloric ration for each dish		Month 4	No
Secondary	Total caloric ration for each dish		Month 5	No
Secondary	Meal compliance for 3 days		Baseline (days -7 to 0)	No
Secondary	Meal compliance for 3 days		Month 1	No
Secondary	Meal compliance for 3 days		Month 2	No
Secondary	Meal compliance for 3 days		Month 3	No
Secondary	Meal compliance for 3 days		Month 4	No
Secondary	Meal compliance for 3 days		Month 5	No
Secondary	Ingested caloric intake		Baseline (days -7 to 0)	No
Secondary	Ingested caloric intake		Month 1	No
Secondary	Ingested caloric intake		Month 2	No
Secondary	Ingested caloric intake		Month 3	No
Secondary	Ingested caloric intake		Month 4	No
Secondary	Ingested caloric intake		Month 5	No
Secondary	Weight (kg)		Baseline (days -7 to 0)	No
Secondary	Weight (kg)		Month 1	No
Secondary	Weight (kg)		Month 2	No
Secondary	Weight (kg)		Month 3	No
Secondary	Weight (kg)		Month 4	No
Secondary	Weight (kg)		Month 5	No
Secondary	Weight (kg)		Month 6	No
Secondary	Serum prealbumin		Baseline (days -7 to 0)	No
Secondary	Serum prealbumin		Month 3	No
Secondary	Serum prealbumin		Month 6	No
Secondary	Serum albumin		Baseline (days -7 to 0)	No
Secondary	Serum albumin		Month 3	No
Secondary	Serum albumin		Month 6	No
Secondary	Serum C reactive protein		Baseline (days -7 to 0)	No
Secondary	Serum C reactive protein		Month 3	No
Secondary	Serum C reactive protein		Month 6	No
Secondary	Glycated hemoglobin (HbA1C) for diabetic patients		Baseline (days -7 to 0)	No
Secondary	Glycated hemoglobin (HbA1C) for diabetic patients		Month 3	No
Secondary	Glycated hemoglobin (HbA1C) for diabetic patients		Month 6	No
Secondary	Presence/absence of comorbidities		Month 6	Yes
Secondary	Mortality		Month 6	Yes
Secondary	Capillary fasting blood glucose for diabetic patients		Month 1	No
Secondary	Capillary fasting blood glucose for diabetic patients		Month 2	No
Secondary	Capillary fasting blood glucose for diabetic patients		Month 3	No
Secondary	Capillary fasting blood glucose for diabetic patients		Month 4	No
Secondary	Capillary fasting blood glucose for diabetic patients		Month 5	No
Secondary	Capillary fasting blood glucose for diabetic patients		Month 6	No