CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Preoperative protein supplementationdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03037294
NCT03037294N/ACompleted

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

Maastricht University Medical Center·interventional·Posted Jan 31, 2017·Updated Feb 8, 2024

In Brief

A clinical study evaluating Preoperative protein supplementation for Osteo Arthritis Knee and Protein Metabolism. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartJan 1, 2017
Primary CompletionJan 19, 2024
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 9.4 years ago

Interventions

Preoperative protein supplementationdietary

Daily 40 g of pre-sleep protein supplementation during 2-week preoperative period.