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.
ID
Source
Brief title
Condition
- Protein and amino acid metabolism disorders NEC
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters include protein synthesis rates and enrichments of
Hoffa*s fat pad, synovium, tendon, bone, muscle, ligament, menisci, and
cartilage.
Secondary outcome
Secondary parameters include whole-body protein synthesis, breakdown,
oxidation, and net balance.
Background summary
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. 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. This proposal is based and builds on METC application 12-3-058,
12-3-059, 15-3-019 and 14T165.
Study 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 (three groups) study design in which the intervention
group will be compared to the control group.
Intervention
Pre-sleep protein supplementation two weeks before TKR, or no intervention.
Study burden and risks
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.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Male and female patients scheduled for total knee arthroplasty
- BMI between 18.5-35 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. systemic
corticosteroids or prescription strength acne medications)
- Lactose intolerance
- Insulineafhankelijke diabetes mellitus
- Alcohol abuse
- Rheumatoid arthritis
- Peripheral artery disease Fontaine III or IV
- COPD GOLD III or IV
- Pheynylketonuria
- Surgical intervention to the knee 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58921.068.16 |