The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

NCT ID: NCT06967220

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2026-04-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Anti-inflammatory diet and supplements

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

Group Type: EXPERIMENTAL

Single leg training

Intervention Type: OTHER

All subjects will train one leg twice daily.

Interventions

Single leg training

All subjects will train one leg twice daily.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Grith Højfeldt

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

BBH170

Identifier Type: -

Identifier Source: org_study_id