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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00509-38 | Other Identifier | RCB number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard evening meal | Active Comparator | Patients randomized to this arm will receive standard evening meals. Intervention: Standard evening meals. |
|
| Improved evening meal | Experimental | Patients randomized to this arm 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. Intervention: Improved evening meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard evening meals. | Other | Patients will receive usual evening meals. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total caloric ration for each dish | 6 months | |
| Meal compliance for 3 days | 6 months | |
| Ingested caloric intake | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total caloric ration for each dish | Baseline (days -7 to 0) | |
| Total caloric ration for each dish | Month 1 | |
| Total caloric ration for each dish |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Rouvière, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Béatrice Hébert, Nurse | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier | Nîmes | 30029 | France |
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| 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. |
|
| Month 2 |
| Total caloric ration for each dish | Month 3 |
| Total caloric ration for each dish | Month 4 |
| Total caloric ration for each dish | Month 5 |
| Meal compliance for 3 days | Baseline (days -7 to 0) |
| Meal compliance for 3 days | Month 1 |
| Meal compliance for 3 days | Month 2 |
| Meal compliance for 3 days | Month 3 |
| Meal compliance for 3 days | Month 4 |
| Meal compliance for 3 days | Month 5 |
| Ingested caloric intake | Baseline (days -7 to 0) |
| Ingested caloric intake | Month 1 |
| Ingested caloric intake | Month 2 |
| Ingested caloric intake | Month 3 |
| Ingested caloric intake | Month 4 |
| Ingested caloric intake | Month 5 |
| Weight (kg) | Baseline (days -7 to 0) |
| Weight (kg) | Month 1 |
| Weight (kg) | Month 2 |
| Weight (kg) | Month 3 |
| Weight (kg) | Month 4 |
| Weight (kg) | Month 5 |
| Weight (kg) | Month 6 |
| Serum prealbumin | Baseline (days -7 to 0) |
| Serum prealbumin | Month 3 |
| Serum prealbumin | Month 6 |
| Serum albumin | Baseline (days -7 to 0) |
| Serum albumin | Month 3 |
| Serum albumin | Month 6 |
| Serum C reactive protein | Baseline (days -7 to 0) |
| Serum C reactive protein | Month 3 |
| Serum C reactive protein | Month 6 |
| Glycated hemoglobin (HbA1C) for diabetic patients | Baseline (days -7 to 0) |
| Glycated hemoglobin (HbA1C) for diabetic patients | Month 3 |
| Glycated hemoglobin (HbA1C) for diabetic patients | Month 6 |
| Presence/absence of comorbidities | Month 6 |
| Mortality | Month 6 |
| Capillary fasting blood glucose for diabetic patients | Month 1 |
| Capillary fasting blood glucose for diabetic patients | Month 2 |
| Capillary fasting blood glucose for diabetic patients | Month 3 |
| Capillary fasting blood glucose for diabetic patients | Month 4 |
| Capillary fasting blood glucose for diabetic patients | Month 5 |
| Capillary fasting blood glucose for diabetic patients | Month 6 |