This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.
This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
Matching placebo solution per day by mouth for 48 weeks.
Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
Boston, Massachusetts, United States
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
Time frame: 48 Weeks
To measure knee cartilage volume over 48 weeks at three time points.
Time frame: 48 Weeks
To measure and evaluate WOMAC pain subscale scores over 48 weeks.
Time frame: 48 Weeks
To evaluate change in physical function tests over 48 weeks.
Time frame: 48 Weeks
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