Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.

Completed

• Conditions: Other Malnutrition
• Interventions: Dietary Supplement: Fortimel Complete

• Registration Number: NCT03083912
• Lead Sponsor: Hospital Viamed Valvanera, Spain

Brief Summary

The hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in Spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.

Detailed Description

A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Age greater than or equal to 65 years,
• Living in nursing homes,
• Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).

Exclusion Criteria

• Tube feeding (nasogastric or gastrostomy)
• Terminally ill or palliative treatment and residents with life expectancy of less than 6 months
• Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fortimel Complete	Fortimel Complete	All of the residents included receive ONS

Primary Outcome Measures

Name	Time	Method
Improve weight	3 months	Difference between the weight of the residents at the beginning and at the end of the study

Secondary Outcome Measures

Name	Time	Method
Barthel index	3 months	Ability in Activities of Daily Living at the end of the study
SPPB scale	3 months	Functional status at the end of the study

Trial Locations

Locations (1)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain