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The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06967220
Acronym
InflaMus
Enrollment
90
Registered
2025-05-13
Start date
2025-05-12
Completion date
2026-04-22
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease Related Malnutrition, Geriatric Assessment, High Systemic Inflammation

Brief 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) 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. .

Interventions

OTHERSingle leg training

All subjects will train one leg twice daily.

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Current use of anti-inflammatory medication * Liver failure * Short bowel syndrome * Chrohn's or colitis * Terminally ill

Design outcomes

Primary

MeasureTime frameDescription
FSR in high vs. low inflammation group7 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

Secondary

MeasureTime frameDescription
Change in muscle size between groups7 days (or until hospital discharge)Change in muscle size during the study period between the three groups
FSR in trained vs. non trained leg7 days (or until hospital discharge)Effect of training on the muscle protein fractional synthesis rate
Inflammation in regular vs. antiinflammatory diet7 days (or until hospital discharge)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.
Muscle size in trained vs. untrained leg7 days (or until hospital discharge)The difference in muscle size in trained vs. untrained leg measured using ultrasound
Change in muscle strength between groups7 days (or until discharge)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)
Muscle strength in trained vs. untrained leg7 days (or until hospital discharge)The difference in leg muscle strength (MVC) in trained vs. untrained leg measured using an isokinetic dynamometer.
AA uptake following feeding7 days (or until hospital discharge)Plasma amino acid profile following a standard meal

Other

MeasureTime frameDescription
Feasibility of training7 days (or until hospital discharge)It will be reported if the subjects can complete a minium of 80% of the twice-daily training sessions.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026