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

Hospital Viamed Valvanera, Spain291 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

291

Conditions

Other Malnutrition

Interventions

Fortimel CompleteDIETARY_SUPPLEMENT

The residents included receive 2 bottle por day.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hospital Universitario Ramón y Cajal

Madrid, Spain

Outcomes

Primary Outcomes

Improve weight

Difference between the weight of the residents at the beginning and at the end of the study

Time frame: 3 months

Secondary Outcomes

SPPB scale

Functional status at the end of the study

Time frame: 3 months

Barthel index

Ability in Activities of Daily Living at the end of the study

Time frame: 3 months

Data from ClinicalTrials.gov

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