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Completed

NCT Number: NCT02329613

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

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.

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Key information

Conditions

Institutionalization

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard evening meals.

Other

Patients will receive usual evening meals.

Improved evening meal

Other

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.

Primary outcomes

  1. Total caloric ration for each dish

    Time frame: 6 months

  2. Meal compliance for 3 days

    Time frame: 6 months

  3. Ingested caloric intake

    Time frame: 6 months

Secondary outcomes

  1. Total caloric ration for each dish

    Time frame: Baseline (days -7 to 0)

  2. Total caloric ration for each dish

    Time frame: Month 1

  3. Total caloric ration for each dish

    Time frame: Month 2

  4. Total caloric ration for each dish

    Time frame: Month 3

  5. Total caloric ration for each dish

    Time frame: Month 4

  6. Total caloric ration for each dish

    Time frame: Month 5

  7. Meal compliance for 3 days

    Time frame: Baseline (days -7 to 0)

  8. Meal compliance for 3 days

    Time frame: Month 1

  9. Meal compliance for 3 days

    Time frame: Month 2

  10. Meal compliance for 3 days

    Time frame: Month 3

  11. Meal compliance for 3 days

    Time frame: Month 4

  12. Meal compliance for 3 days

    Time frame: Month 5

  13. Ingested caloric intake

    Time frame: Baseline (days -7 to 0)

  14. Ingested caloric intake

    Time frame: Month 1

  15. Ingested caloric intake

    Time frame: Month 2

  16. Ingested caloric intake

    Time frame: Month 3

  17. Ingested caloric intake

    Time frame: Month 4

  18. Ingested caloric intake

    Time frame: Month 5

  19. Weight (kg)

    Time frame: Baseline (days -7 to 0)

  20. Weight (kg)

    Time frame: Month 1

  21. Weight (kg)

    Time frame: Month 2

  22. Weight (kg)

    Time frame: Month 3

  23. Weight (kg)

    Time frame: Month 4

  24. Weight (kg)

    Time frame: Month 5

  25. Weight (kg)

    Time frame: Month 6

  26. Serum prealbumin

    Time frame: Baseline (days -7 to 0)

  27. Serum prealbumin

    Time frame: Month 3

  28. Serum prealbumin

    Time frame: Month 6

  29. Serum albumin

    Time frame: Baseline (days -7 to 0)

  30. Serum albumin

    Time frame: Month 3

  31. Serum albumin

    Time frame: Month 6

  32. Serum C reactive protein

    Time frame: Baseline (days -7 to 0)

  33. Serum C reactive protein

    Time frame: Month 3

  34. Serum C reactive protein

    Time frame: Month 6

  35. Glycated hemoglobin (HbA1C) for diabetic patients

    Time frame: Baseline (days -7 to 0)

  36. Glycated hemoglobin (HbA1C) for diabetic patients

    Time frame: Month 3

  37. Glycated hemoglobin (HbA1C) for diabetic patients

    Time frame: Month 6

  38. Presence/absence of comorbidities

    Time frame: Month 6

  39. Mortality

    Time frame: Month 6

  40. Capillary fasting blood glucose for diabetic patients

    Time frame: Month 1

  41. Capillary fasting blood glucose for diabetic patients

    Time frame: Month 2

  42. Capillary fasting blood glucose for diabetic patients

    Time frame: Month 3

  43. Capillary fasting blood glucose for diabetic patients

    Time frame: Month 4

  44. Capillary fasting blood glucose for diabetic patients

    Time frame: Month 5

  45. Capillary fasting blood glucose for diabetic patients

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: IRCAR

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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