The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention

Not Applicable

Completed

• Conditions: Symptomatic Knee Osteoarthritis
• Interventions: Dietary Supplement: Ascorbic acid; Dietary Supplement: Ascorbic acid / phytochemical supplement

• Registration Number: NCT04783792
• Lead Sponsor: Harokopio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ascorbic acid	Ascorbic acid	Ascorbic acid group
ascorbic acid / phytochemical supplement	Ascorbic acid / phytochemical supplement	A mixture of active phenolic compounds with ascorbic acid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
Circulating oxidative damage markers	3 months	MPO, oxLDL, serum oxidisability
Circulating miRNAs	3 months	miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p

Trial Locations

Locations (2)

Harokopio University; 🇬🇷 Athens, Attica, Greece

Evgenidio Hospital; 🇬🇷 Athens, Greece