We aim to determine the effects of collagen supplementation on biomarkers of collagen metabolism in the two weeks following total hip arthroplasty in older adults with osteoarthritis.
ID
Source
Brief title
Condition
- Protein and amino acid metabolism disorders NEC
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
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.
Background summary
Osteoarthritis is a highly prevalent degenerative disease characterized by
disturbances in the collagenous tissues of joints (e.g. cartilage, bone) that
leads to pain, functional decline and reduced quality of life. Although the
onset of the disease can be linked to a number of causes such as injury or
overuse, the most prominent risk factor of osteoarthritis is age. The (partial)
replacement of joints (i.e. arthroplasty) is a common surgical procedure
performed on patients with osteoarthritis when other treatment options are
insufficient. During arthroplasty, damaged cartilage and bone are removed and
replaced with prostheses in order to improve function and reduce pain. Despite
the prevalence of this procedure, it is not yet well established what occurs to
collagen metabolism perioperatively and in the early stages of recovery. Such
knowledge could provide relevant insight for improving treatment to support
post-operative healing. One such treatment option could be collagen
supplementation, which has been shown to boost collagen synthesis in healthy
individuals. However, the effect of collagen supplementation on collagen
metabolism during recovery from arthroplasty remains to be investigated.
Study objective
We aim to determine the effects of collagen supplementation on biomarkers of
collagen metabolism in the two weeks following total hip arthroplasty in older
adults with osteoarthritis.
Study design
This is a double-blind placebo-controlled intervention study.
Intervention
This study involves a 2-week nutritional intervention in which the participants
will be randomly allocated into an intervention group (HC), receiving daily
supplementation of 15g hydrolysed collagen with 48mg vitamin C, or a placebo
group (PLA), receiving an energy-matched supplementation of 15g maltodextrin
with 48mg vitamin C.
Study burden and risks
Participation in this study poses minimal risk. The subjects will receive a
blood draw on five occasions; the first (baseline, day 0), second (during
surgery, day 0), and third (morning after surgery, day 1) samples are taken via
an infusion line that is already placed as of standard in-hospital treatment
procedures (no additional burden), and the fourth (day 4), and the last blood
draw (day 15) will be additional to *standard care procedures*. Participants
will have to consume a daily supplement for 2 weeks and will be asked to record
dietary intake for 3 days, which may be seen as burdensome. The beverage for
both groups contains 48mg vitamin C, which is not associated with negative side
effects. The intervention group will ingest 15g hydrolysed collagen protein
daily, which is well tolerable and may have a facilitatory role in the recovery
process. The placebo group will receive 15g maltodextrin daily, which is well
tolerable and has no adverse effects.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
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
Medical products/devices used
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 | NL78139.068.21 |
| Other | NL9608 |