NCT03037294: KneeT

Protein Turnover in the Osteoarthritic Knee

Completed NA Last updated 8 February 2024

What this trial tests

NA trial testing Preoperative protein supplementation in Osteo Arthritis Knee in 27 participants. Completed in 19 January 2024.

Timeline

1 January 2017

Primary endpoint
19 January 2024

19 January 2024

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	27
Start date	1 January 2017
Primary completion	19 January 2024
Estimated completion	19 January 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• Preoperative protein supplementation

Conditions studied

• Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →
• Protein Metabolism — all drugs for Protein Metabolism →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Osteo Arthritis Knee or Protein Metabolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessing the responsiveness of musculoskeletal tissues to protein supplementation in vivo in older adults: an exploratory randomized controlled trial.
   Houtvast DC, Hendriks FK, Weijzen ME, Zorenc AH, et al · · 2026 · PMID 42142739 · DOI 10.1016/j.ajcnut.2026.101349