Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes. (PROT-e-GER)

Hospital Viamed Valvanera, Spain

Status: Completed

Conditions: Other Malnutrition

Treatments: Dietary Supplement: Fortimel Complete

Study type: Observational

Funder types: Other

Identifiers

NCT03083912

PROT-e-GER

Details and patient eligibility

About

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.

Full description

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

Enrollment: 291 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

291 participants in 1 patient group

Fortimel Complete

Description:

All of the residents included receive ONS

Treatment:

Dietary Supplement: Fortimel Complete