Symptomatic Knee Osteoarthritis
Conditions
Keywords
symptomatic knee osteoartritis, phenolic compound,
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAscorbic acid / phytochemical supplement
Ascorbic acid / phytochemical supplement
DIETARY_SUPPLEMENTAscorbic acid
Ascorbic acid
Sponsors
Harokopio University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symptomatic knee OA (patients with at least moderate symptoms) * patients should be able to walk without a medical or other support device (such as a walking stick, crutches, or a kneecap).
Exclusion criteria
* Patients undergoing physical therapy or TENS, have rheumatoid arthritis, fibromyalgia, spinal disorders or any other disorders that according to the physician is a bias, stiffness\> 30 minutes, have scheduled knee surgery or any other programmed surgery during the trial, show WOMAC pain scale \<4 for pain overall, those with a diagnosis of kidney or liver disease, coagulation disorders, any form of cancer, HIV infection, type I diabetes, those with unregulated type II diabetes, those using illicit substances or having a history of substance or alcohol abuse over the past 2 years (or those who consume more than 2 typical alcoholic beverages / day in the present), those using corticosteroids within 2 months prior to randomization and during the trial, those who change their diet or supplementation 1 month or during the recruitment/trial, those using ascorbic acid supplement or any phytochemical-rich supplement, women on estrogen replacement therapy, during pregnancy or lactation and those judged by the researcher as unable to perceive and comply with the obligations laid down in the Protocol and for which consent and voluntary participation is sought.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC™ Osteoarthritis Index Pain Subscale | 3 months | 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. |
| Visual Analogue Scale - VAS | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire SF-36 | 3 months | SF-36 is a self-reporting set of generic, coherent, and easily administered quality-of-life measures. |
| Circulating Inflammatory markers | 3 months | IL-1beta, IL-6, IL-13, TNF-alpha, endothelin |
| WOMAC™ Osteoarthritis Index Stiffness Score | 3 months | 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 |
| Circulating miRNAs | 3 months | miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p |
| Circulating oxidative damage markers | 3 months | MPO, oxLDL, serum oxidisability |
| WOMAC™ Osteoarthritis Index Physical Function Score | 3 months | 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 |
Countries
Greece
Outcome results
None listed