This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native type-II collagen, on healthy adults with joint discomfort. Half of the participants will receive the b-2Cool containing supplement while the other half will receive a placebo pill.
Previous studies had shown the efficacy of the intake of native collagen to relieve pain in healthy patients with joint discomfort. Native collagen is detected in the gut's Peyer's patches and, thanks to a mechanism known as oral tolerisation, reduces the autoimmune attack to joints' collagen improving joint function and pain. Oral tolerance consists of two phases of immune response: the maintenance of homeostasis and the suppression of immune responses mediated by Ag-specific regulatory T cells. T-cells detect the epitopes of type-II collagen in the gut and suppress the immune response against bodily type-II collagen. Then, these regulatory T cells generated in the gut are presumed to migrate to a local microenvironment where a protein analogous to the orally dosed antigen resides, in this case type-II collagen. Upon reactivation in a new microenvironment, regulatory cells will suppress ongoing inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Change from baseline of ultrasonographic assessment of synovial effusion
Time frame: 0, 6, 12 and 24 weeks
Visual Analog Scale (VAS) pain evaluation
Time frame: 0, 6, 12 and 24 weeks
WOMAC Functional assesment
Time frame: 0, 6, 12 and 24 weeks
Subjective evaluation of quality of life
Patients will report some aspects of their Quality of life through Visual analogic scales
Time frame: 0, 6, 12 and 24 weeks
Collagen degradation markers in urine
Time frame: 0, 12 and 24 weeks
Patient's satisfaction
Patient satisfaction will be evaluated using a subjective questionnaire
Time frame: 6, 12 and 24 weeks
Rescue medication consumption
Time frame: Every 2 weeks for 24 weeks
Adverse events
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.