Nutritional RiskNUTRIMUSCLENCT05556876
Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan
A study testing Protein omega-3 in people with Nutritional Risk and Rehabilitation, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Risk, Rehabilitation, Oral Nutritional Supplements
- What is being tested?
- Protein omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Protein omega-3
- Keywords
- muscle strenght, quality of life, body composition, protein intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein omega-3Dietary supplement
An oral supplement with a high content of protein and with essential fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge Receives: Dietary Supplement: Protein omega-3 |
| Control | No intervention | the control group will receive usual care after discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Muscle strength
Chair stand
Measured: change from baseline to 12 weeks follow-up
Secondary outcomes (14)
Hand grip Muscle strength
Hand grip strength
Measured: 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
Measured: 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
Measured: Change from baseline to 6 and 12 weeks follow-up
energy and protein intake
24 hour dietary recall
Measured: 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
Measured: Change from baseline to 12 week follow-up
Muscle mass
Calf circumference assessment of muscle mass
Measured: 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
Measured: 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.
Measured: 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
Measured: at 12 weeks follow-up
readmissions
number, length and percentage of readmissions after discharge will be calculated
Measured: 30 days and 38 weeks after discharge
mortality
number and percentage of mortality after discharge will be calculated
Measured: 30 days and 38 weeks after discharge
inflammation
blood measurements of CRP and omega-3 fatty acids
Measured: change from baseline to 12 weeks follow-up
vitamin D status
blood measurements of vitamin D
Measured: change from baseline to 12 weeks follow-up
Hydration status
Blood measurements and calculation of serum osmolarity
Measured: Change from Baseline to 12 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Dec 2023
- Primary completion30 Sep 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutritional RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blinded randomised study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia, Inc.
- Responsible party
- Principal investigator, Anne Marie Beck, Herlev and Gentofte Hospital
- Investigators
- Tina Munk, PhD, Study director, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556876
- Sponsor's protocol ID
- version2/30.03.2022
- Acronym
- NUTRIMUSCLE
- Status last verified
- May 2026
- First submitted
- 21 Sep 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42299674Jensen 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.
PubMed 42383884Jensen 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.
PubMed 41566545
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk Discharged With a Rehabilitation Plan
- ClinicalTrials.gov ID
- NCT05556876
- Acronym / sponsor ID
- NUTRIMUSCLE / version2/30.03.2022
- Keywords
- muscle strenght, quality of life, body composition, protein intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Nutricia, Inc.
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blinded randomised study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Protein omega-3the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge |
| Control | No intervention | –the control group will receive usual care after discharge |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Men and women aged ≥ 65 years old
- Independent stand function
Key exclusion criteria (10 listed)
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein omega-3An oral supplement with a high content of protein and with essential fatty acids | Dietary supplement | Intervention |
Primary outcome
Leg Muscle strength
Time frame: change from baseline to 12 weeks follow-up
Chair stand
14 secondary outcomes
Hand grip Muscle strength
Time frame: change from baseline to 12 weeks follow-up
Health related quality of life
Time frame: Change from baseline to 6 and 12 weeks follow-up
Activities of daily living
Time frame: Change from baseline to 6 and 12 weeks follow-up
energy and protein intake
Time frame: at 12 weeks follow-up
Appetite
Time frame: Change from baseline to 12 week follow-up
Muscle mass
Time frame: Change from baseline to 12 week follow-up
Frailty
Time frame: Change from baseline to 12 weeks follow-up
initiation and completion of rehabilitation
Time frame: at 12 week follow-up
compliance to oral nutritional supplements
Time frame: at 12 weeks follow-up
readmissions
Time frame: 30 days and 38 weeks after discharge
mortality
Time frame: 30 days and 38 weeks after discharge
inflammation
Time frame: change from baseline to 12 weeks follow-up
vitamin D status
Time frame: change from baseline to 12 weeks follow-up
Hydration status
Time frame: Change from Baseline to 12 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication: PubMed 42299674Jensen 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.
- Results publication: PubMed 42383884Jensen 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.
- Results publication: PubMed 41566545Jensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Munk, PhD study director
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein omega-3 in people with Nutritional Risk and Rehabilitation, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Muscle strength (time frame: change from baseline to 12 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.