No registrations found.
ID
Source
Brief title
Health condition
Osteoarthritis of the hip
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of this study are the changes in serum concentrations of biomarkers of collagen metabolism perioperatively and up to two weeks after surgery. These biomarkers represent bone and cartilage synthesis (N-terminal propeptide of type I and type II collagen, respectively: P1NP, P2NP) and breakdown (C-terminal telopeptide of type I and type II collagen, respectively: CTx1, CTx2).
Secondary outcome
Secondary endpoints include changes in plasma amino acid concentrations and pain and functional outcomes.
Background summary
Total hip arthroplasty (THA) is a common procedure used to treat hip osteoarthritis (a degenerative disease affecting collagen-rich joint tissues). Little is known about the efficacy of post-operative nutritional intervention to aid recovery after THA. It is hypothesized that ingesting collagen protein may beneficially alter collagen metabolism. This study aims to assess the effect of post-operative collagen supplementation on biomarkers of collagen metabolism in the two weeks following THA in older adults with osteoarthritis. Forty older adults with osteoarthritis will be randomly allocated to receive daily supplementation of either 15g collagen protein or isocaloric placebo, with 48mg vitamin C during the two-weeks following THA. Biomarkers of collagen metabolism will be measured via blood samples, which will be taken before, during, 1 day after, 4 days after, and 15 days after THA. The primary endpoints are changes in serum concentrations of biomarkers of collagen metabolism before and after supplementation. Secondary endpoints are changes in plasma concentrations of amino acids as well as pain and functional outcomes. We expect that collagen supplementation will increase collagen synthesis and reduce collagen breakdown, which may suggest a therapeutic role of collagen ingestion to assist recover after total hip arthroplasty.
Study objective
Collagen supplementation will augment the increase in biomarkers of collagen synthesis compared to placebo in patients with osteoarthritis after total hip arthroplasty.
Study design
Blood will be collected at 5 time points:
1. Day of operation (pre);
2. During operation;
3. Day after operation;
4. Four days after operation;
5. Fourteen days after operation
Intervention
The intervention consists of two-weeks of (15g) daily collagen supplementation or isoenergetic placebo (maltodextrine) following total hip arthroplasty.
Inclusion criteria
• Written informed consent
• With osteoarthritis and due for total hip arthroplasty
• ≥ 60 years old
• BMI 18.5-35 kg/m2
Exclusion criteria
• Taking medications known to influence protein metabolism
• Collagen allergy
• Diabetes mellitus
• Alcohol abuse
• Surgical intervention in past four weeks
• GFR <20mL/min/1.73m2
• Rheumatoid arthritis
• Collagen disorders
• Cancer
• Gastrointestinal disease
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9608 |
| Other | METC azM/UM : METC 21-045 |