|- candidate number||24203|
|- NTR Number||NTR5825|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-apr-2016|
|- Secondary IDs||NL56165.072.15; IRBN2015019 IRBN Nijmegen|
|- Public Title||Effects of protein supplementation on knee complaints during and after repetitive walking exercise|
|- Scientific Title||“Effects of collagen peptide supplementation on knee JOINT discomfort during and after repetitive low-INtensity exercise”|
|- hypothesis||We hypothesize that participants administered with collagen peptide show a reduction in activity-related knee discomfort during and after repetitive low-intensity exercise compared to participants administered with placebo.|
|- Healt Condition(s) or Problem(s) studied||Knee, Pain, Walking|
|- Inclusion criteria||o Registration for the Nijmegen Four Days Marches 2016|
o Self-reported activity-related knee discomfort (VAS score ≥1)
o Between 50 and 75 years of age
o Willingness to provide written consent after proper information about the study objectives and procedures.
|- Exclusion criteria||o A known systemic joint or muscle disease|
o Individuals that follow a low protein diet for medical reasons due to known kidney disease.
o Disease influencing the uptake of protein (i.e. inflammatory bowel disease, Crohn’s disease)
o Vegetarian diet
o Diabetes mellitus (type 1 and type 2)
o Recent knee surgery (< 6 months)
o Use of statins or other medicines that influence muscle health
o Use of other dietary supplements for joint health (i.e. glucosamine, chondroitin)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-apr-2016|
|- planned closingdate||31-dec-2016|
|- Target number of participants||200|
|- Interventions||The investigational product is named Peptan®B. PeptanB is pure collagen peptides (synonyms: collagen hydrolysate, hydrolysed collagen, hydrolysed gelatin) and is produced by hot water extraction of the endogenous collagen from bovine hide and subsequent enzymatic hydrolysis. Peptan is food grade, has a GRAS (generally recognized as safe) status and is used as a dietary supplement and food ingredient for the past 10 years.
Peptan consists of type 1 collagen and contains 90% of protein, representing 97% of its dry weight. Corresponding to the endogenous collagen it is produced from, Peptan has a specific amino acid composition with high levels of glycine, proline and hydroxyproline. The enzymatic hydrolysis produces a mix of peptides of different length with a mean molecular weight between 2000 and 5000 Dalton.
The placebo consists of maltodextrin produced from dehydrated glucose syrup from wheat, whose organoleptic quality and caloric content are very similar to those of the test product (Peptan®B).
|- Primary outcome||(Changes in) activity-related knee discomfort expressed by the VAS-score (=∆VAS: baseline – 12 weeks of intervention) |
|- Secondary outcome||o (Changes in) activity-related knee discomfort expressed by and the KOOS score Lysholm score|
o Handgrip strength
o Maximal voluntary strength of the quadriceps muscle (in only 40 subjects)
o Fatigue-index and force-frequency relationship of the quadriceps muscle (in only 40 subjects)
o Inflammatory markers (IL-6, IL-1beta, TNF-alpha, MCP-1, hsCRP)
o Bone and joint markers (PINP, CTX, osteocalcin, CP2, CTXII)
o Analgesics usage
o Subject characteristics (anthropometrics)
o Protein intake (24h recall)
o Physical activity (SQUASH)
|- Timepoints||o (Changes in) activity-related knee discomfort expressed by the VAS-score (5 time points)|
o (Changes in) activity-related knee discomfort expressed by and the KOOS score Lysholm score (5 time points)
o Handgrip strength (2 time points)
o Maximal voluntary strength of the quadriceps muscle (2 time points)
o Fatigue-index and force-frequency relationship of the quadriceps muscle (2 time points)
o Inflammatory markers (IL-6, IL-1beta, TNF-alpha, MCP-1, hsCRP) (4 time points)
o Bone and joint markers (PINP, CTX, osteocalcin, CP2, CTXII) (4 time points)
o Analgesics usage (5 time points)
o Subject characteristics (anthropometrics) (1 time point)
o Protein intake (24h recall) (2 time points)
o Physical activity (SQUASH) (3 time points)
|- Trial web site||www.vierdaagseonderzoek.nl/knieklachten|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Coen Bongers|
|- CONTACT for SCIENTIFIC QUERIES|| Maria Hopman|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary||Rationale: |
Many older individuals experience joint pain during and after exercise. This experienced pain discourages them to regularly perform physical activity, thereby reducing the weekly dose of exercise and its associated health benefits. Knee pain in elderly is often caused by arthrosis, but in many older individuals there is no specific cause for the experienced activity-related knee pain. Reduction of the exercise-induced knee pain is likely to increase exercise participation and stimulate health. Several studies have shown that oral supplementation with collagen peptides reduces knee joint discomfort and improves knee joint functioning in patient and student populations. However, it remains unclear whether collagen peptides have similar positive effects on activity-related knee joint discomfort in healthy older individuals.
To study the effects of collagen peptide supplementation on knee joint discomfort in active elderly with activity-related knee discomfort.
Randomized, double-blind, controlled trial
200 individuals registered to participate in the Nijmegen Four Days Marches 2016, with activity-related knee discomfort indicated on a VAS scale (VAS score ≥1).
Daily supplementation of collagen peptide (10g) or placebo (maltodextrin; 10g), additionally to their habitual breakfast for a period of 12 weeks. All supplements will be provided as flavored powder drink products that can be dissolved in water.
Main study parameters/endpoints:
The primary outcome parameter is the difference in activity-related knee discomfort expressed by the VAS-score at baseline and after the intervention period (=∆VAS score) between the intervention and placebo group. Furthermore, questionnaires, handgrip strength, muscle contraction characteristics, analgesics usage, inflammatory markers and bone and joint markers will be assessed as secondary outcome parameters.
|- Main changes (audit trail)|
|- RECORD||7-apr-2016 - 22-jun-2016|