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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo arm will take a pill each day containing only excipients |
|
| b-2Cool | Experimental | The b-2Cool arm will take a pill each day containing 40 mg of b-2Cool and excipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| b-2Cool | Dietary Supplement | b-2Cool® is native type II collagen extracted from chicken sternums |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of ultrasonographic assessment of synovial effusion | 0, 6, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) pain evaluation | 0, 6, 12 and 24 weeks | |
| WOMAC Functional assesment | 0, 6, 12 and 24 weeks | |
| Subjective evaluation of quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Möller, Dr. | Instituto Poal de ReumatologĂa | Principal Investigator |
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| Placebo |
| Other |
Excipients only |
|
Patients will report some aspects of their Quality of life through Visual analogic scales |
| 0, 6, 12 and 24 weeks |
| Collagen degradation markers in urine | 0, 12 and 24 weeks |
| Patient's satisfaction | Patient satisfaction will be evaluated using a subjective questionnaire | 6, 12 and 24 weeks |
| Rescue medication consumption | Every 2 weeks for 24 weeks |
| Adverse events | 6 months |