The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention

Symptomatic Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783792
• Other study ID #: OA supplement_( )
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Symptomatic Knee Osteoarthritis

Intervention

Dietary Supplement:
• Ascorbic acid / phytochemical supplement
Ascorbic acid / phytochemical supplement
• Ascorbic acid
Ascorbic acid

Locations

Country	Name	City	State
Greece	Evgenidio Hospital	Athens
Greece	Harokopio University	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

Outcome

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