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Completed

NCT Number: NCT03083912

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

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.

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Key information

Conditions

Other Malnutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fortimel Complete

Dietary Supplement

The residents included receive 2 bottle por day.

Other names: ONS

Primary outcomes

  1. Improve weight

    Time frame: 3 months

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

Secondary outcomes

  1. SPPB scale

    Time frame: 3 months

    Functional status at the end of the study

  2. Barthel index

    Time frame: 3 months

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

Other outcomes

  1. Number of drinking bottles during the study.

    Time frame: 3 months

    Evaluate the compliance with the oral nutritional supplementation

Sponsors and collaborators

Lead sponsor

Hospital Viamed Valvanera, Spain

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Ramon y Cajal

Registry information

Official study title

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

Acronym: PROT-e-GER

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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