Status:
COMPLETED
The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention
Lead Sponsor:
Harokopio University
Conditions:
Symptomatic Knee Osteoarthritis
Eligibility:
All Genders
35+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04783792
Start Date
November 1 2020
End Date
December 31 2022
Last Update
March 1 2023
Active Locations (2)
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1
Harokopio University
Athens, Attica, Greece, 17671
2
Evgenidio Hospital
Athens, Greece