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REDUCING EARLY ATROPHY WITH LEUCINE DURING IMMOBILIZATION OF SKELETAL MUSCLE

REDUCING EARLY ATROPHY WITH LEUCINE DURING IMMOBILIZATION OF SKELETAL MUSCLE - REALISM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45771
Enrollment
64
Registered
2015-12-30
Start date
2016-04-24
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Muscle Protein Turover

Interventions

Three days of immobilization via a full leg cast One leg will be immobilized at a 30 degree knee joint angle of flexion for 3 days by means of leg cast (see Figure 1). The leg to be immobilized will

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Moderately active * Male or female age 18-35 or 60-80 years of age inclusive * BMI not lower than 18.5 and not higher than 30 kg/m2 * Having given informed consent

Exclusion criteria

Exclusion criteria: * Previous participation in a 13C amino acid tracer study (within the last 5 years) * Lower limb and/or back injuries * A history of thrombosis/cardiovascular disease * Use of anticoagulants * Musculoskeletal/orthopedic disorders * Structured resistance exercise training * Use of corticosteroids * Current use of protein supplements (during the study) * Diabetes (type I or II) * Pregnancy * Hormone replacement therapy * Third generation oral contraceptives * Use of tobacco products

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint The main study endpoint is cumulative FSR as a measure of muscle protein synthesis rates (MPS) based on the oral tracer deuterium oxide. In order to determine cumulative FSR, the following parameters will be measured via GC-C-IRMS and GCMS respectively: * Muscle protein-bound L-[2,3,3,3-2H4]-alanine enrichment (expressed as MPE) * Plasma free L-[2,3,3,3-2H4]-alanine enrichment (expressed as MPE) * Saliva 2H2O enrichment (Expressed as APE)

Secondary

MeasureTime frame
Secondary study parameters/endpoints Secondary endpoints include: * Quadriceps whole-muscle CSA as assessed via CT scan. * Plasma, muscle free, and muscle protein-bound L-[ring-13C6]-phenylalanine enrichment. * Fractional breakdown rates (FBR) of muscle protein based on 3,3-D2 phenylalanine tracer dilution in plasma and muscle. * Fractional synthesis rates (FSR) of muscle protein based on L-[ring-13C6]-phenylalanine tracer incorporation into bound muscle protein. * Activation of signaling molecules regulating muscle protein synthesis and breakdown (specified in 8.3.6.5) will be established via Western blots. Quantitative Real-Time PCR Analysis of MAFbx/Atrogin-1, MuRF1, FoxO and Ubiquitin Expression will also be performed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 2, 2026