Skip to main content
OpenTrials
Completed

NCT Number: NCT05556876

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nutritional Risk Oral Nutritional Supplements Rehabilitation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte hospital

Herlev, 2730, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Protein omega-3

Dietary Supplement

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

Primary outcomes

  1. Leg Muscle strength

    Time frame: change from baseline to 12 weeks follow-up

    Chair stand

Secondary outcomes

  1. Hand grip Muscle strength

    Time frame: change from baseline to 12 weeks follow-up

    Hand grip strength

  2. Health related quality of life

    Time frame: Change from baseline to 6 and 12 weeks follow-up

    EQ5D5L questionnaire with five dimensions and five level of answers. To be converted to an index were -1 is worst and 1 is best health related quality of life

  3. Activities of daily living

    Time frame: Change from baseline to 6 and 12 weeks follow-up

    Functional recovery score The eleven-item questionnaire is comprised of three main components: basic activities of daily living (BADL) assessed by four items, instrumental activities of daily living (IADL) assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100 percent

  4. energy and protein intake

    Time frame: at 12 weeks follow-up

    24 hour dietary recall

  5. Appetite

    Time frame: Change from baseline to 12 week follow-up

    Simplified Nutritional Appetite Questionnaire [SNAQ. The questionnaire results in a score ranging from 5 to 20, where 5 is lowest appetite

  6. Muscle mass

    Time frame: Change from baseline to 12 week follow-up

    Calf circumference assessment of muscle mass

  7. Frailty

    Time frame: Change from baseline to 12 weeks follow-up

    The "FRAIL" Questionnaire includes questions concerning Fatigue, Resistance (capability of stair climbing),Aerobic( walking distance), Illnesses (multi morbidity), and Loss of weight. Physical frailty, pre-frailty and non-frailty is defined as having 3 or greater; 1 or 2 or no factors respectively

  8. initiation and completion of rehabilitation

    Time frame: at 12 week follow-up

    questionnaire were participants can document their attendance to exercise rehabilitation and reasons for not attending.

  9. compliance to oral nutritional supplements

    Time frame: at 12 weeks follow-up

    a diary were participants can register their intake of supplements and eventual side effects. A compliance of 100% is aimed for as optimal

  10. readmissions

    Time frame: 30 days and 38 weeks after discharge

    number, length and percentage of readmissions after discharge will be calculated

  11. mortality

    Time frame: 30 days and 38 weeks after discharge

    number and percentage of mortality after discharge will be calculated

  12. inflammation

    Time frame: change from baseline to 12 weeks follow-up

    blood measurements of CRP and omega-3 fatty acids

  13. vitamin D status

    Time frame: change from baseline to 12 weeks follow-up

    blood measurements of vitamin D

  14. Hydration status

    Time frame: Change from Baseline to 12 weeks follow up

    Blood measurements and calculation of serum osmolarity

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • Nutricia, Inc.

Registry information

Official study title

Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk Discharged With a Rehabilitation Plan

Acronym: NUTRIMUSCLE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 27, 2022
Registry last updated
Jul 7, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.