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Completed

NCT Number: NCT04783792

The Effect of Phenolic Compounds 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.

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Key information

Conditions

Symptomatic Knee Osteoarthritis

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ascorbic acid / phytochemical supplement

Dietary Supplement

Ascorbic acid / phytochemical supplement

ascorbic acid

Dietary Supplement

Ascorbic acid

Primary outcomes

  1. WOMAC™ Osteoarthritis Index Pain Subscale

    Time frame: 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.

  2. Visual Analogue Scale - VAS

    Time frame: 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 outcomes

  1. WOMAC™ Osteoarthritis Index Stiffness Score

    Time frame: 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

  2. WOMAC™ Osteoarthritis Index Physical Function Score

    Time frame: 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

  3. Questionnaire SF-36

    Time frame: 3 months

    SF-36 is a self-reporting set of generic, coherent, and easily administered quality-of-life measures.

  4. Circulating Inflammatory markers

    Time frame: 3 months

    IL-1beta, IL-6, IL-13, TNF-alpha, endothelin

  5. Circulating oxidative damage markers

    Time frame: 3 months

    MPO, oxLDL, serum oxidisability

  6. Circulating miRNAs

    Time frame: 3 months

    miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Official study title

The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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