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

NCT05556876 | Completed

• 1 other identifier: version2/30.03.2022
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutritional Risk; Rehabilitation; Oral Nutritional Supplements

Keywords

muscle strenght; quality of life; body composition; protein intake

Outcome Measures

Primary Outcomes (1)

• Leg Muscle strength

  Chair stand

  change from baseline to 12 weeks follow-up

Secondary Outcomes (14)

• Hand grip Muscle strength

  change from baseline to 12 weeks follow-up

• Health related quality of life

  Change from baseline to 6 and 12 weeks follow-up

• Activities of daily living

  Change from baseline to 6 and 12 weeks follow-up

• energy and protein intake

  at 12 weeks follow-up

• Appetite

  Change from baseline to 12 week follow-up

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Dietary Supplement: Protein omega-3

Control

NO INTERVENTION

the control group will receive usual care after discharge

Interventions

Protein omega-3 DIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Nutricia, Inc.: collaborator

Study Sites (1)

Herlev and Gentofte hospital

Herlev, 2730, Denmark

Location

Related Publications (3)

• Jensen A, Ninh ED, Knudsen AW, Munk T, Beck AM. Effect of oral nutritional supplements on mortality and hospital admissions in older hip fracture patients at nutritional risk: secondary analysis of a randomised controlled trial. Clin Rehabil. 2026 Jun 16:2692155261459227. doi: 10.1177/02692155261459227. Online ahead of print.

  PMID: 42299674 RESULT

• Jensen A, Ninh ED, Darlem BB, Haack LM, Moller CM, Knudsen AW, Pudselykke FE, Petersen PB, Beck AM. Effect of oral nutritional supplements on physical functional performance in older patients at nutritional risk discharged with a rehabilitation plan: A randomised controlled trial. Clin Rehabil. 2026 Jul 1:2692155261462462. doi: 10.1177/02692155261462462. Online ahead of print.

  PMID: 42383884 RESULT

• 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.

  PMID: 41566545 RESULT

Study Officials

• Tina Munk, PhD

  Herlev and Gentofte Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: two set of files
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: A single-blinded randomised study

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 27, 2022
• Study Start: December 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: March 30, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-05

Locations

DK (1)