The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

Not Applicable

• Conditions: Disease Related Malnutrition; High Systemic Inflammation; Geriatric Assessment

• Registration Number: NCT06967220
• Lead Sponsor: Bispebjerg Hospital

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. .

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-05-08
• Study Start: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-04-22
• Study Completion: 2026-04-22

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
FSR in high vs. low inflammation group	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 Outcome Measures

Name	Time	Method
Change in muscle size between groups	7 days (or until hospital discharge)	Change in muscle size during the study period between the three groups
FSR in trained vs. non trained leg	7 days (or until hospital discharge)	Effect of training on the muscle protein fractional synthesis rate
AA uptake following feeding	7 days (or until hospital discharge)	Plasma amino acid profile following a standard meal
Muscle size in trained vs. untrained leg	7 days (or until hospital discharge)	The difference in muscle size in trained vs. untrained leg measured using ultrasound
Inflammation in regular vs. antiinflammatory diet	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.
Change in muscle strength between groups	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)
Muscle strength in trained vs. untrained leg	7 days (or until hospital discharge)	The difference in leg muscle strength (MVC) in trained vs. untrained leg measured using an isokinetic dynamometer.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark