Disease Related MalnutritionInflaMusNCT06967220
The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients
A study testing Single leg training in people with Disease Related Malnutrition and High Systemic Inflammation, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The main goal is to elucidate the mechanistic coupling between inflammation and the ability to maintain skeletal muscle through physical exercise while hospitalized. We will investigate protein kinetics in patients who belong to one of three groups 1) high inflammatory state, 2) moderate inflammatory state and 3)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Disease Related Malnutrition, High Systemic Inflammation, Geriatric Assessment
- What is being tested?
- Single leg training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 12 May 2025to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalised at the geriatric department at Bispebjerg Hospital with an expected admission time of minimum 7 days
- Have Disease Related Malnutrition (DRM)
- Able to carry out strength training
- Able to understand the study information, as assessed by the research team
Who cannot join
- Current use of anti-inflammatory medication
- Liver failure
- Short bowel syndrome
- Chrohn's or colitis
- Terminally ill
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The main goal is to elucidate the mechanistic coupling between inflammation and the ability to maintain skeletal muscle through physical exercise while hospitalized. We will investigate protein kinetics in patients who belong to one of three groups 1) high inflammatory state, 2) moderate inflammatory state and 3) low/no inflammation. We will further intervene in group 1 (high inflammatory state) with anti-inflammatory nutrition (primarily green-solution plant-based) to diminish activity in inflammatory pathways. The hypothesis is that inflammation will inhibit protein synthesis in skeletal muscle both in resting muscle and in strength trained skeletal musculature, and that a lowering of the inflammatory status by anti-inflammatory nutrition will enhance the exercise induced formation of new muscle mass. .
- Being tested
- Single leg training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single leg trainingOther
All subjects will train one leg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory diet and supplements | Experimental | A sub group of patients with high inflammation will be offered a diet where 50% of the regular hospital diet is switched for diet containing plant based food and nutrients found to lower inflammation Receives: Other: Single leg training |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSR in high vs. low inflammation group
The primary outcome is the muscle protein fractional synthesis rate (FSR) in the high inflammation group vs. the low inflammation group
Measured: 7 days (or until hospital discharge)
Secondary outcomes (7)
Change in muscle size between groups
Change in muscle size during the study period between the three groups
Measured: 7 days (or until hospital discharge)
FSR in trained vs. non trained leg
Effect of training on the muscle protein fractional synthesis rate
Measured: 7 days (or until hospital discharge)
Inflammation in regular vs. antiinflammatory diet
Comparison of the changes in plasma C-Reactive Protein (CRP) from day 1 till discharge between the group ingesting regular diet vs. the group ingesting an anti-inflammatory diet.
Measured: 7 days (or until hospital discharge)
AA uptake following feeding
Plasma amino acid profile following a standard meal
Measured: 7 days (or until hospital discharge)
Muscle size in trained vs. untrained leg
The difference in muscle size in trained vs. untrained leg measured using ultrasound
Measured: 7 days (or until hospital discharge)
Change in muscle strength between groups
Description: Change in muscle strength during the study period between the three groups. Hand muscle strength is measured using a hand dynamometer, and leg muscle strength (MVC) is measured using an isokinetic dynamometer.
Time Frame: 7 days (or until hospital discharge)
Measured: 7 days (or until discharge)
Muscle strength in trained vs. untrained leg
The difference in leg muscle strength (MVC) in trained vs. untrained leg measured using an isokinetic dynamometer.
Measured: 7 days (or until hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start12 May 2025
- Primary completion22 Apr 2026 (estimated)
- Study completion22 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Related MalnutritionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grith Højfeldt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967220
- Sponsor's protocol ID
- BBH170
- Acronym
- InflaMus
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT06967220
- Acronym / sponsor ID
- InflaMus / BBH170
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 22 Apr 2026 (estimated)
- First posted
- 13 May 2025 (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 main goal is to elucidate the mechanistic coupling between inflammation and the ability to maintain skeletal muscle through physical exercise while hospitalized. We will investigate protein kinetics in patients who belong to one of three groups 1) high inflammatory state, 2) moderate inflammatory state and 3) low/no inflammation. We will further intervene in group 1 (high inflammatory state) with anti-inflammatory nutrition (primarily green-solution plant-based) to diminish activity in inflammatory pathways. The hypothesis is that inflammation will inhibit protein synthesis in skeletal muscle both in resting muscle and in strength trained skeletal musculature, and that a lowering of the inflammatory status by anti-inflammatory nutrition will enhance the exercise induced formation of new muscle mass. .
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory diet and supplements | Experimental | Other: Single leg trainingA sub group of patients with high inflammation will be offered a diet where 50% of the regular hospital diet is switched for diet containing plant based food and nutrients found to lower inflammation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Hospitalised at the geriatric department at Bispebjerg Hospital with an expected admission time of minimum 7 days
- Have Disease Related Malnutrition (DRM)
- Able to carry out strength training
- Able to understand the study information, as assessed by the research team
Key exclusion criteria (5 listed)
- Current use of anti-inflammatory medication
- Liver failure
- Short bowel syndrome
- Chrohn's or colitis
- Terminally ill
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 |
|---|---|---|
| Single leg trainingAll subjects will train one leg twice daily. | Other | Anti-inflammatory diet and supplements |
Primary outcome
FSR in high vs. low inflammation group
Time frame: 7 days (or until hospital discharge)
The primary outcome is the muscle protein fractional synthesis rate (FSR) in the high inflammation group vs. the low inflammation group
7 secondary outcomes
Change in muscle size between groups
Time frame: 7 days (or until hospital discharge)
FSR in trained vs. non trained leg
Time frame: 7 days (or until hospital discharge)
Inflammation in regular vs. antiinflammatory diet
Time frame: 7 days (or until hospital discharge)
AA uptake following feeding
Time frame: 7 days (or until hospital discharge)
Muscle size in trained vs. untrained leg
Time frame: 7 days (or until hospital discharge)
Change in muscle strength between groups
Time frame: 7 days (or until discharge)
Muscle strength in trained vs. untrained leg
Time frame: 7 days (or until hospital discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Disease Related Malnutrition
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Tolerance and Acceptability of an Oral Nutrition Supplement
Disease Related Malnutrition
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single leg training in people with Disease Related Malnutrition and High Systemic Inflammation, run by Bispebjerg 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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 15 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
FSR in high vs. low inflammation group (time frame: 7 days (or until hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.