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

Herlev and Gentofte Hospital

Status

Invitation-only

Conditions

Oral Nutritional Supplements

Rehabilitation

Nutritional Risk

Treatments

Dietary Supplement: Protein omega-3

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05556876

version2/30.03.2022

Details and patient eligibility

About

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

Full description

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

Enrollment

123 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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