The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

NCT06967220 | Enrolling By Invitation

• 1 other identifier: BBH170
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. .

Conditions

Disease Related Malnutrition; High Systemic Inflammation; Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

• 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

  7 days (or until hospital discharge)

Secondary Outcomes (7)

• Change in muscle size between groups

  7 days (or until hospital discharge)

• FSR in trained vs. non trained leg

  7 days (or until hospital discharge)

• Inflammation in regular vs. antiinflammatory diet

  7 days (or until hospital discharge)

• AA uptake following feeding

  7 days (or until hospital discharge)

• Muscle size in trained vs. untrained leg

  7 days (or until hospital discharge)

Other Outcomes (1)

• Feasibility of training

  7 days (or until hospital discharge)

Study Arms (1)

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

Other: Single leg training

Interventions

Single leg training OTHER

All subjects will train one leg twice daily.

Anti-inflammatory diet and supplements

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 13, 2025
• Study Start: May 12, 2025
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-04

Locations

DK (1)