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Study of a milk protein concentrate supplement to help recovery after hip or knee replacement surgery

The effect of Milk Protein Concentrate (MPC) supplement on functional recovery, muscle strength, inflammatory and oxidative markers in elderly patients following total hip or knee arthroplasty: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19487444
Enrollment
100
Registered
2026-03-23
Start date
2023-07-31
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Primary knee or hip arthroplasty due to end-stage osteoarthritis of the lower limbs Musculoskeletal Diseases

Interventions

The intervention consists of oral nutritional supplementation with Protifar (Nutricia), a high-protein Milk Protein Concentrate (MPC) powder. The formula features a low sodium and potassium profile an

Sponsors

International Hellenic University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and over 2. Scheduled for elective primary total hip or knee arthroplasty at 424 General Military Hospital 3. Ability to provide written informed consent and willingness to comply with the nutritional supplementation protocol and follow-up assessments

Exclusion criteria

Exclusion criteria: Current key exclusion criteria 31/03/2026: 1. Known allergy to milk and soy proteins or severe lactose intolerance 2. Severe renal impairment or kidney disease 3. Autoimmune diseases, Cognitive impairment, dementia, or psychiatric disorders, neuro-muscular disorders 4. Rheumatoid arthritis or active infection 5. Revision surgery 6. Individuals with active implantable medical devices. Previous key exclusion criteria: 1. Known allergy to milk and soy proteins or severe lactose intolerance 2. Severe renal impairment or kidney disease 3. Autoimmune diseases, Cognitive impairment, dementia, or psychiatric disorders, neuro-muscular disorders 4. Rheumatoid arthritis or active infection 5. Revision surgery

Design outcomes

Primary

MeasureTime frame
Functional performance measured using handgrip strength(kgr); endurance (4 meters gait speed (m/sec); static balance (Single leg stance test(sec); time for 5 repetitions sit to stand test(sec) at 24 hours before surgery and 15 weeks post-operatively;Skeletal Muscle Mass(kgr); Lean Mass (kgr) measured using Bioelectrical Impedance Analysis(kgr) at 24 hours before surgery and 15 weeks post-operatively

Secondary

MeasureTime frame
Inflammation measured using C Reactive Protein in serum(mg/dL) at 24 hours before surgery and 15 weeks post-operatively;Oxidative Stress measured using 8-Isporostane in plasma and urine(pg/ml) at 24 hours before surgery and 15 weeks post-operatively;Clinical and biochemical data, including blood and urine analysis (CRP and 8-isoprostane levels), as recorded in the study’s structured assessment forms. These measures are part of the protocol approved by the Scientific Council of the 424 General Military Training Hospital (Session July 2023, 6th Topic), evaluating the impact of the MPC nutritional intervention (notified to EOF, Prot. No. 81732/13-11-2009)." measured using 8-Isporostane in plasma and urine(pg/ml) and CRP (mg/dl) at 24 hours before surgery and 15 weeks post-operatively

Countries

Greece

Contacts

Public ContactMaria Spanoudaki
maryspan1@gmail.com+30 6936 853 437

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026