Clinical trial NCT04783792: The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention
Official title: The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Knee Osteoarthritis
Keywords: symptomatic knee osteoartritis, phenolic compound,
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: WOMAC™ Osteoarthritis Index Pain Subscale
timeFrame: 3 months
measure: Visual Analogue Scale - VAS
timeFrame: 3 months
Secondary outcomes:
measure: WOMAC™ Osteoarthritis Index Stiffness Score
timeFrame: 3 months
measure: WOMAC™ Osteoarthritis Index Physical Function Score
timeFrame: 3 months
measure: Questionnaire SF-36
timeFrame: 3 months
measure: Circulating Inflammatory markers
timeFrame: 3 months
measure: Circulating oxidative damage markers
timeFrame: 3 months
measure: Circulating miRNAs
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
state: Attica
city: Athens
country: Greece
facility: Evgenidio Hospital
Study officials:
References: