The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 24 weeks…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the change over time in the Dutch version of the
VISA-P score. This simple, validated, reliable and injury-specific
questionnaire assesses the severity of patellar tendinopathy and is sensitive
to small changes in symptoms. It is specifically designed for patellar
tendinopathy, assessing pain, symptoms, simple function test and ability to
participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no
pain, maximum function and maximum ability to participate in sports. The score
decreases with increasing severity of PT symptoms. The VISA-P questionnaire
will be administered at baseline and after 24 weeks of follow-up. The primary
outcome measure is the difference between intervention and placebo in
difference score between t=24 and t=0.
Secondary outcome
Secondary outcomes will include: Pain during functional tests, advanced imaging
methods and tendon structure and stiffness measurements (ultrasound, UTC,
Myoton), blood levels of amino acids and inflammatory markers measured in
blood, and dietary habits, that will all be measured at baseline, at 12 weeks
and at 24 weeks of follow-up. In addition, data on the compliance with the
exercise program and supplement intake, training and competition load will be
collected weekly using an online questionnaire.
Background summary
Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence
rates in elite and recreational athletes. PT sometimes results in a prolonged
absence from sport participation, hampering individuals to achieve their
desired performance levels and to benefit from the health related effects of
sports participation. Many treatment options are used but management of PT
remains challenging. Current treatment involves progressive education, load
management and tendon loading exercises (PTLE). Recent studies have shown that
nutrition can positively affect collagen synthesis in musculoskeletal tissues.
A study showed that supplementing 15g of gelatine combined with 50mg of Vitamin
C, 1 hour before loading exercises, resulted in an increase in whole body
collagen synthesis and increased mechanics and collagen content of human
engineered ligaments. However the effectiveness of oral supplementation of
hydrolysed collagen in combination with vitamin C in athletes with PT has not
been studied in a randomized controlled trial yet.
Study objective
The primary aim of this RCT is to evaluate whether the use of oral
supplementation of hydrolysed collagen/vitamin C in addition to usual care
(education, load management and PTLE) is superior to usual care and placebo on
VISA-P score after 24 weeks for athletes with PT. The secondary aim of this RCT
is to evaluate whether the use of oral supplementation of hydrolysed
collagen/vitamin C in addition to usual care (education, load management and
PTLE) is superior to usual care and placebo on other clinical outcome
parameters, functional tests and tendon structure after 12 and 24 weeks for
athletes with PT.
Study design
The JUMPFOOD-study is a double blinded, 2-armed randomized placebo controlled
trial which investigates the effectiveness of oral supplementation of
hydrolysed collagen and vitamin C combined with progressive tendon loading
exercise compared to only progressive tendon loading exercises in athletes with
PT.
Intervention
The intervention consists of a nutritional supplement with 10g hydrolysed
collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting
of maltodextrin. All participants in both groups will receive education, load
management advices and a criteria-based PTLE consisting of 4 stages within the
limits of pain during 24-weeks, until full recovery. This (training)
intervention has recently been proven to be superior to eccentric training.
Participants will be randomly assigned to receive either the nutritional
supplement hydrolysed collagen/vitamin C (intervention) or a placebo
supplement.
Study burden and risks
The time investment of participation consists of following the exercise program
3 times a week during the entire 24-week study period, and of completing a
total of 4 hospital visits for inclusion, at baseline, and at follow-up at 12
and 24 weeks. Both groups are expected to benefit from the PTLE exercise
therapy as this has recently been demonstrated in a RCT. Participants have to
consume the nutritional supplement or placebo supplement daily during the
entire study period. The nutritional supplement contains hydrolysed collagen
and vitamin C. Too much vitamin C will leave the body via urine and causes no
health risks. Collagen is also present in normal food products and is not known
to cause any problems. During test days, ultrasounds will be performed without
contrast agents, so risks are very small. Blood withdrawals can lead to
bruises, but changes are small. Filling in the questionnaires during the study
period takes some time but these questionnaires are not psychologically
demanding. All potential participants will be examined by an experienced sports
physician and additional imaging will be performed to exclude other diagnoses
and increase the likelihood of the diagnosis PT, without additional healthcare
costs.
Willy Brandtlaan 10
Ede 6716 RP
NL
Willy Brandtlaan 10
Ede 6716 RP
NL
Listed location countries
Age
Inclusion criteria
- Signed informed consent.
- Age 16 - 40 years old
- History of focal knee pain in patellar tendon or its patellar or tibial
insertion in association with training and/or competition.
- Current symptom duration of at least 12 weeks.
- Sports participation at least once a week for at least one year.
- Palpation tenderness to the corresponding painful area on the patellar tendon.
- Focal patellar tendon pain during patellar tendon loading pain provocation
test (single leg decline squat and/or single leg jump squat)
- Victorian Institute of Sports Assessment (VISA-P) score < 80 out of 100
points.
- Willing to take (non-vegetarian) nutritional supplements.
- Willing and able to perform the PTLE program.
Exclusion criteria
- Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout
or rheumatoid arthritis) or familial hypercholesterolaemia.
- Signs or symptoms of other coexisting knee pathology on physical examination
(such as joint effusion and joint line tenderness) or additional diagnostics
(Chondral lesion of the patella or trochlea on MRI or prepatellar bursitis on
US).
- Daily use of drugs with a putative effect on the patellar tendon in the
preceding year (e.g. fluoroquinolones and statins).
- Having had a patellar tendon surgery.
- Having had a knee surgery without full recovery.
- Previous patellar tendon rupture of the index knee.
- Local injection therapy with corticosteroids, other drugs, blood, platelet
rich plasma or stem cells in the preceding 12 months.
- Acute knee or patellar tendon injuries (other than PT).
- Participation in other concomitant treatment programs.
- Participation in other research projects during participation of the JUMPFOOD
study.
- Already using (hydrolysed) collagen supplementation.
- Giving blood donation in a period of two months prior to each test day.
- Being pregnant or wish to become pregnant in the upcoming year.
- Alcohol consumption for men >21 units/week and >4/day; for women >14
units/week and >3/day.
- Abuse of hard drugs.
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 |
|---|---|
| Other | NL79100.081.21 in register.clinicaltrials.gov |
| CCMO | NL79100.091.22 |