An interventional study of Glucosamine (a dietary supplement) and 16 oz lite lemonade in Osteoarthritis, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-14.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
The goal of this study is 1) to develop a biomarker of of cartilage synthesis by determining if there is a relationship between changes in the status of knee cartilage and the amount of a biomarker called CTX-II in urine. 2) We will also characterize people who have experienced cartilage loss and/or reduced functional ability using performance tests and a questionnaire. 3) The administration of glucosamine in a beverage for six months will be used to promote the alteration in cartilage status and improve function in people with mild to moderate joint pain. A secondary goal will be to assess the effect of glucosamine on the skin in a small subset of women.
Reduced knee function is a significant cause of physical limitations and disability. As cartilage deteriorates due to aging, wear-and-tear, injury, or disease, joint space narrowing and pain can develop. The lost of articular cartilage arises from an imbalance between cartilage synthesis and cartilage degradation. When cartilage needs to be remodeled, enzymes such as matrix metalloproteinases (MMPs) degrade type II collagen. It now may be possible to use new molecular markers of cartilage degradation to assess the progression of joint loss in comparison with radiographic changes of the knee joint. Urinary excretion of C-terminal cross linking telopeptide of type II collagen (CTX-II) is a new molecular marker of cartilage tissue degradation metabolism.
Recent evidence suggests that glucosamine, a dietary supplement, may provide some relief from joint pain and may increase the functional ability to participate in activities of daily living. This may be a result of these dietary supplements stimulating tissue repair such as cartilage in the affected joints, or by inhibiting the degradation of cartilage through an inhibition of enzymes. Moreover, Braham, Dawson, \& Goodman (2003) reported increases in function in adults with knee pain following 12 -weeks of glucosamine supplementation. It is unclear, however, if glucosamine delivered via a liquid carrier would improve physical function and impact quality of life measures in people who have experienced loss of knee cartilage.
Glucosamine is a precursor for glycosaminoglycans, which are a major component of both joint cartilage and skin. Potential benefits of glucosamine on skin have been reported previously. It is possible that glucosamine in a beverage might also improve skin parameters over time.
Comparisons: 100 men and women with mild to moderate joint pain taking a liquid with glucosamine, compared to 100 men and women with mild to moderate joint pain taking a liquid with placebo.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 201 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
1500 mg of lite lemonade
Other: 16 oz lite lemonade
1500 mg glucosamine in 16 oz lite lemonade 1 time daily for 6 months
Dietary Supplement: Glucosamine (a dietary supplement)
1500 mg in 16 oz lite lemonade, once per day for 6 months
16 oz lite lemonade 1 time daily for 6 months
Also known as: Minute Maid
Urinary excretion of CTX-II at 3 and 6 months post intervention
Time frame: 3 and 6 months
Measurement of bone marrow lesions, cartilage volume, as shown by MRI post intervention
Time frame: 6 month
Scores on WOMAC and KOOS of knee pain and function
Time frame: 3 and 6 months
Scores on performance measures
Time frame: 6 months
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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