Protein Turnover in the Osteoarthritic Knee

Osteo Arthritis Knee Clinical Trial

— KneeT  

Official title:

Protein Turnover in the Osteoarthritic Knee; the Impact of Preoperative Protein Intake and Intra-articular Corticosteroid Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037294
• Other study ID #: 16-3-036
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 19, 2024

Study information

• Verified date: February 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: Osteoarthritis (OA) of the knee is a common cause of pain and disability, especially in people over the age of 65. In the current health care system both conservative (e.g. intra-articular injections with corticosteroids) and surgical (total knee replacement, TKR) treatment are applied. Although frequently used, certain effects of these treatments on protein metabolism remain unclear. It is well known that maintenance of different tissues is determined by a dynamic balance between protein synthesis and breakdown rates, with temporary changes in either protein synthesis or breakdown allowing net protein accretion or loss. Though protein supplementation has shown to be an effective nutritional strategy in stimulating muscle protein synthesis, it remains unclear to what extent other musculoskeletal tissues are able to respond to dietary protein supplementation. Therefore, the current study assesses the impact of preoperative protein supplementation on protein synthesis in different musculoskeletal tissues of the knee.

Objective: To investigate the effect of preoperative protein supplementation on Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and cartilage protein synthesis of the OA knee.

Study design: Randomized, parallel (two groups) study design. The intervention group will be compared to the control group.

Study population: 24 adults with OA of the knee undergoing TKR. Intervention: Daily 40 g of pre-sleep protein two weeks before TKR or no intervention.

Main study parameters/endpoints: Primary study parameters include protein synthesis rates and enrichments of Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and cartilage. Secondary parameters include whole-body protein synthesis, breakdown, oxidation, and net balance.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks involved in participating in this study are minimal. There are no potential effects known for the ingestion of protein. Muscle biopsies and tissue collection will be performed during the surgical procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Male and female patients scheduled for total knee arthroplasty

• BMI between 18.5-30 kg/m2

• Age > 18 years

• Mentally competent, as judged by the treating physician

• Functioning gastrointestinal tract, eligible for oral protein supplementation

Exclusion Criteria:

• Corticosteroid injections less than 3 months prior to participation

• Any medications know to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)

• Lactose intolerance

• Insulin-dependent diabetes mellitus

• Alcohol abuse

• Rheumatoid arthritis

• Peripheral artery disease Fontaine III or IV

• COPD GOLD III or IV

• Phenylketonuria

• Surgical intervention in the past four weeks

• Total parenteral nutrition at day of surgery

• Neoadjuvant chemotherapy or radiotherapy

• GFR <20 mL/min/1.73 m2

• Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, OD, or malignant processes

• Collagen disorders, e.g. Marfan and Ehler-Danlos

• Any other medical condition that may interfere with the safety of the subjects or the outcome parameters, in the investigators judgement

• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol instructions

• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Protein Metabolism

Intervention

Dietary Supplement:
• Preoperative protein supplementation
Daily 40 g of pre-sleep protein supplementation during 2-week preoperative period.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tissue-specific protein synthesis rates	Fractional synthetic rates calculated based on tissue-free, plasma, and protein-bound tracer enrichments using stable isotope methodology and D2O dosing methodology.	Throughout the surgical procedure (stable isotope methodology) and during the 2-week preoperative period (D2O dosing methodology).