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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Ascorbic acid / phytochemical supplement
Ascorbic acid
Harokopio University
Athens, Attica, Greece
Evgenidio Hospital
Athens, Greece
WOMAC™ Osteoarthritis Index Pain Subscale
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). 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.
Time frame: 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.
Time frame: 3 months
WOMAC™ Osteoarthritis Index Stiffness Score
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Time frame: 3 months
WOMAC™ Osteoarthritis Index Physical Function Score
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
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Time frame: 3 months
Questionnaire SF-36
SF-36 is a self-reporting set of generic, coherent, and easily administered quality-of-life measures.
Time frame: 3 months
Circulating Inflammatory markers
IL-1beta, IL-6, IL-13, TNF-alpha, endothelin
Time frame: 3 months
Circulating oxidative damage markers
MPO, oxLDL, serum oxidisability
Time frame: 3 months
Circulating miRNAs
miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p
Time frame: 3 months