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The main objective of the study is to elucidate the beneficial effect of a dietary supplement with phenolic compounds in patients with OA versus ascorbic acid.
The analysis of the data is expected to clarify the role of the new supplement as one with a positive effect on OA-related biomarkers, on functional abilities and on the quality of life of patients with OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ascorbic acid / phytochemical supplement | Experimental | A mixture of active phenolic compounds with ascorbic acid |
|
| ascorbic acid | Experimental | Ascorbic acid group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic acid / phytochemical supplement | Dietary Supplement | Ascorbic acid / phytochemical supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMACâ„¢ Osteoarthritis Index Pain Subscale | It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 3 months |
| Visual Analogue Scale - VAS | The Visual Analogue Scale - VAS is a unidimensional measure of pain intensity. It is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| WOMACâ„¢ Osteoarthritis Index Stiffness Score | It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harokopio University | Athens | Attica | 17671 | Greece | ||
| Evgenidio Hospital |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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A randomized double-blind clinical intervention with two parallel groups lasting 3 months is proposed to elucidate the beneficial effect of a novel food supplement on OA.
Participants will undergo clinical and biochemical testing and will provide a complete medical history and history of the disease. Demographics, smoking, alcohol consumption, eating habits and physical activity, pain, and functional inability to enroll in the study will also be recorded.
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| Ascorbic acid | Dietary Supplement | Ascorbic acid |
|
| 3 months |
| WOMACâ„¢ Osteoarthritis Index Physical Function Score | It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
| 3 months |
| Questionnaire SF-36 | SF-36 is a self-reporting set of generic, coherent, and easily administered quality-of-life measures. | 3 months |
| Circulating Inflammatory markers | IL-1beta, IL-6, IL-13, TNF-alpha, endothelin | 3 months |
| Circulating oxidative damage markers | MPO, oxLDL, serum oxidisability | 3 months |
| Circulating miRNAs | miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p | 3 months |
| Athens |
| Greece |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |