Undernutrition Clinical Trial
Official title:
Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.
The objective is to study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in elderly patients.
Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at
admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and
oral nutritional supplements if needed. Still, a considerable part of these patients are
unable to meet protein requirements and are still at risk of undernutrition at hospital
discharge. This may impair recovery of illness, partly due to loss of muscle mass and
physical performance. To improve protein intake, Cater with Care products have been
developed: a selection of foods and drinks that are consumed often by elderly persons, but
now enriched with protein up to 10 grams per portion. We hypothesize that these products
help to reach protein requirements in elderly patients during and after hospital stay and
thereby improve their health outcomes.
Objective: To study the effectiveness of supplementing a standard hospital and 12-week home
menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5
g/kg/day and in improving functional status after hospital stay in elderly patients.
Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a
hospital phase including all admitted patients and a home phase with a selection of
patients.
Study population: Patients of 65 years or over who are admitted to the departments of
Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.
Intervention: The control group receives the standard hospital menu for elderly at risk of
undernutrition (energy and protein rich) and a variety of foods and drinks to be used as
part of their home diet for 12 weeks after hospitalization. Foods and drinks for home use
are non-enriched variants of Cater with Care products (e.g. normal fruit juice).
The intervention group receives Cater with Care protein-enriched foods and drinks during
hospital stay (in addition to the standard hospital menu) and at home as part of their home
diet for 12 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06084715 -
The INSTITUT Study
|
||
| Recruiting |
NCT05608707 -
APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.
|
N/A | |
| Completed |
NCT01977950 -
Nutritional Risk and Nutritional Care Practices in the Hospitalized Elderly
|
N/A | |
| Completed |
NCT01197768 -
A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly
|
N/A | |
| Active, not recruiting |
NCT02463565 -
Assessment of Food Intake in Hospitalized Patients
|
N/A | |
| Completed |
NCT05517395 -
The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors
|
N/A | |
| Recruiting |
NCT05473312 -
Women Supporting Women to Improve Infant and Child Feeding Practices
|
N/A | |
| Recruiting |
NCT05094024 -
Shelf-Stable MDCF-2 for Children With Undernutrition
|
N/A | |
| Completed |
NCT04105621 -
Westlake Personalized Nutrition and Health Cohort for Drug Addicts
|
||
| Completed |
NCT02141256 -
Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks?
|
N/A | |
| Active, not recruiting |
NCT03450174 -
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
|
N/A | |
| Completed |
NCT05574842 -
The Effect of Double Duty Interventions on Double Burden of Malnutrition Among School Adolescents in Ethiopia
|
N/A | |
| Recruiting |
NCT05952479 -
The Comparison of Handgrip Strength, Lean Mass, and Blood Pressure in Primary School Children Aged 8-10 Years Old With Undernutrition and Normal Nutritional Status
|
||
| Completed |
NCT04640389 -
Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.
|
||
| Completed |
NCT03378141 -
Maternal Nutrition Interventions in Uttar Pradesh, India
|
N/A | |
| Completed |
NCT03211845 -
Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients
|
N/A | |
| Completed |
NCT02656186 -
Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition
|
Phase 3 | |
| Completed |
NCT02476110 -
The ONSHUG Survey : A Quality Care Programme
|
N/A | |
| Completed |
NCT02496247 -
Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
|
N/A | |
| Active, not recruiting |
NCT01303016 -
Improving Nutrition and Health Outcomes in Intibuca, Honduras
|
N/A |