The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention

The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention

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 Overview

• Status: Completed
• Conditions: Symptomatic Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: Ascorbic acid / phytochemical supplement; Dietary supplement: Ascorbic acid

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana C Kaliora, Prof.; Phone Number: +30 2109549226; Email: akaliora@hua.gr
• Study Contact Backup: Name: Andriana Kaliora, Prof; Phone Number: 6976094521; Email: andrianakaliora@gmail.com

Study Locations

• Greece
  • Athens, Greece
    • Evgenidio Hospital
  • Attica
    • Athens, Attica, Greece, 17671
      • Harokopio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ascorbic acid / phytochemical supplement; A mixture of active phenolic compounds with ascorbic acid	Dietary supplement: Ascorbic acid / phytochemical supplement; Ascorbic acid / phytochemical supplement
Experimental: ascorbic acid; Ascorbic acid group	Dietary supplement: Ascorbic acid; Ascorbic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 months
Questionnaire SF-36	SF-36 is a self-reporting set of generic, coherent, and easily administered quality-of-life measures.	3 months
Circulating Inflammatory markers	IL-1beta, IL-6, IL-13, TNF-alpha, endothelin	3 months
Circulating oxidative damage markers	MPO, oxLDL, serum oxidisability	3 months
Circulating miRNAs	miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p	3 months

Collaborators and Investigators

• Sponsor: Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: symptomatic knee osteoartritis, phenolic compound,
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: OA supplement_( )

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No