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Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan

NCT ID: NCT05556876

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-03-30

Brief Summary

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The purpose of the study is to investigate whether an extra intake of energy and protein in the form of nutritional drinks twice a day for 12 weeks can improve muscle strength, muscle mass, quality of life and the implementation of rehabilitation in elderly patients at nutritional risk who are discharged to municipal rehabilitation

Detailed Description

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The study is a single-blind randomised study where the subjects will be randomly divided into two groups. A group that must consume nutritional drinks in connection with their rehabilitation and a group that must do nothing extra. Based on a statistical power calculation, we will include a total of 124 patients.

In connection with the experiment, different data will be collected three times, in connection with the discharge from the hospital, after 6 weeks via the telephone and after 12 weeks. During a home visit. Here, various questionnaires will have to be answered and data on muscle strength and muscle mass will be collected. Further CRP, vitamin D status and EPA/DHA content in blood will be assessed.

In addition, data is collected from the patient's medical record about e.g. readmissions

Conditions

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Nutritional Risk Rehabilitation Oral Nutritional Supplements

Keywords

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muscle strenght quality of life body composition protein intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-blinded randomised study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
two set of files

Study Groups

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Intervention

the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge

Group Type ACTIVE_COMPARATOR

Protein omega-3

Intervention Type DIETARY_SUPPLEMENT

An oral supplement with a high content of protein and with essential fatty acids

Control

the control group will receive usual care after discharge

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Protein omega-3

An oral supplement with a high content of protein and with essential fatty acids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women aged ≥ 65 years old
* Independent stand function

* Able to speak and understand Danish
* At nutritional risk according to NRS-2002
* (Expected to be) discharged with a new rehabilitation plan
* Admitted to the medical and orthopaedic departments of Gentofte or Herlev Hospital

Exclusion Criteria

* Active cancer

* Renal insufficiency (eGFR \< 27 mL/min/1.73m2)
* Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
* Terminal disease
* Exclusively receiving texture modified food, enteral or parenteral nutrition
* Planning to lose weight/go on a special diet
* Planned transfer to other hospitals/departments
* Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA)

* Taking fish-oil supplements as a medical prescription due to hypertriglyceridemia
* Taking fish-oil supplements for other reasons and do not wish to stop this during the study period
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia, Inc.

INDUSTRY

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Marie Beck

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tina Munk, PhD

Role: STUDY_DIRECTOR

Herlev and Gentofte Hospital

Locations

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Herlev and Gentofte hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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version2/30.03.2022

Identifier Type: -

Identifier Source: org_study_id