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Enrolling by Invitation

NCT Number: NCT06967220

The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

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. .

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Key information

Conditions

Disease Related Malnutrition Geriatric Assessment High Systemic Inflammation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single leg training

Other

All subjects will train one leg twice daily.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in muscle size between groups

    Time frame: 7 days (or until hospital discharge)

    Change in muscle size during the study period between the three groups

  2. FSR in trained vs. non trained leg

    Time frame: 7 days (or until hospital discharge)

    Effect of training on the muscle protein fractional synthesis rate

  3. Inflammation in regular vs. antiinflammatory diet

    Time frame: 7 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.

  4. AA uptake following feeding

    Time frame: 7 days (or until hospital discharge)

    Plasma amino acid profile following a standard meal

  5. Muscle size in trained vs. untrained leg

    Time frame: 7 days (or until hospital discharge)

    The difference in muscle size in trained vs. untrained leg measured using ultrasound

  6. Change in muscle strength between groups

    Time frame: 7 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)

  7. Muscle strength in trained vs. untrained leg

    Time frame: 7 days (or until hospital discharge)

    The difference in leg muscle strength (MVC) in trained vs. untrained leg measured using an isokinetic dynamometer.

Other outcomes

  1. Feasibility of training

    Time frame: 7 days (or until hospital discharge)

    It will be reported if the subjects can complete a minium of 80% of the twice-daily training sessions.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Acronym: InflaMus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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