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

November 24, 2017 updated by: Vincenzo Malafarina, MD MSc, Hospital Viamed Valvanera, Spain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Malnourished elderly living in nursing homes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fortimel Complete
All of the residents included receive ONS
Dietary supplement: Fortimel Complete
The residents included receive 2 bottle por day.
Other Names:
  • ONS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Viamed Valvanera, Spain

Collaborators

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

Investigators

  • Study Chair: Nuria Fernandez Bodas, Nutricia, Inc.
  • Study Director: Alfonso Cruz Jentoft, MD PhD, Head of Geriatric Department, Hospital Universitario Ramón y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROT-e-GER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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