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

Effect of High Protein, High-calorie Nutritional Supplementation in Malnourished Elderly in Nursing Homes. A Prospective, Observational, Multicentric Study (PROT-e-GER Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03083912

Acronym

PROT-e-GER

Enrollment

291

Registered

2017-03-20

Start date

2016-03-31

Completion date

2017-10-31

Last updated

2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Malnutrition

Keywords

Malnutrition, Disability, Oral Nutritional Supplementation

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.

Interventions

DIETARY_SUPPLEMENTFortimel Complete

The residents included receive 2 bottle por day.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Improve weight	3 months	Difference between the weight of the residents at the beginning and at the end of the study

Secondary

Measure	Time frame	Description
SPPB scale	3 months	Functional status at the end of the study
Barthel index	3 months	Ability in Activities of Daily Living at the end of the study

Other

Measure	Time frame	Description
Number of drinking bottles during the study.	3 months	Evaluate the compliance with the oral nutritional supplementation

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026