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

Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk 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

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Oral Nutritional Supplements; Nutritional Risk
• Intervention / Treatment: Dietary supplement: Protein omega-3

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge	Dietary supplement: Protein omega-3; An oral supplement with a high content of protein and with essential fatty acids
No Intervention: Control; the control group will receive usual care after discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg Muscle strength	Chair stand	change from baseline to 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip Muscle strength	Hand grip strength	change from baseline to 12 weeks follow-up
energy and protein intake	24 hour dietary recall	at 12 weeks follow-up
Appetite	Simplified Nutritional Appetite Questionnaire [SNAQ. The questionnaire results in a score ranging from 5 to 20, where 5 is lowest appetite	Change from baseline to 12 week follow-up
Frailty	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	Change from baseline to 12 weeks follow-up
initiation and completion of rehabilitation	questionnaire were participants can document their attendance to exercise rehabilitation and reasons for not attending.	at 12 week follow-up
compliance to oral nutritional supplements	a diary were participants can register their intake of supplements and eventual side effects. A compliance of 100% is aimed for as optimal	at 12 weeks follow-up
inflammation	blood measurements of CRP and omega-3 fatty acids	change from baseline to 12 weeks follow-up
vitamin D status	blood measurements of vitamin D	change from baseline to 12 weeks follow-up
Muscle mass	Calf circumference assessment of muscle mass	Change from baseline to 12 week follow-up
Hydration status	Blood measurements and calculation of serum osmolarity	Change from Baseline to 12 weeks follow up
Health related quality of life	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	Change from baseline to 6 and 12 weeks follow-up
Activities of daily living	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	Change from baseline to 6 and 12 weeks follow-up
readmissions	number, length and percentage of readmissions after discharge will be calculated	30 days and 38 weeks after discharge
mortality	number and percentage of mortality after discharge will be calculated	30 days and 38 weeks after discharge

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Nutricia, Inc.
• Investigators: Study Director: Tina Munk, PhD, Herlev and Gentofte Hospital

Publications and helpful links

General Publications

• Jensen A, Ninh ED, Tetens I, Beck AM. Oral nutritional supplements for older hip fracture patients at nutritional risk (NUTRI-MUSCLES)-a feasibility trial for a two-armed RCT. Pilot Feasibility Stud. 2026 Jan 21;12(1):26. doi: 10.1186/s40814-026-01763-4.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; body composition; muscle strenght; protein intake
• Other Study ID Numbers: version2/30.03.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plans yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No