The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention

NCT04783792 | Completed

• 1 other identifier: OA supplement_( )
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Symptomatic Knee Osteoarthritis

Keywords

symptomatic knee osteoartritis, phenolic compound,

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• WOMAC™ Osteoarthritis Index Stiffness Score

  3 months

• WOMAC™ Osteoarthritis Index Physical Function Score

  3 months

• Questionnaire SF-36

  3 months

• Circulating Inflammatory markers

  3 months

• Circulating oxidative damage markers

  3 months

Study Arms (2)

ascorbic acid / phytochemical supplement

EXPERIMENTAL

A mixture of active phenolic compounds with ascorbic acid

Dietary Supplement: Ascorbic acid / phytochemical supplement

ascorbic acid

EXPERIMENTAL

Ascorbic acid group

Dietary Supplement: Ascorbic acid

Interventions

Ascorbic acid / phytochemical supplement DIETARY_SUPPLEMENT

Ascorbic acid / phytochemical supplement

ascorbic acid / phytochemical supplement

Ascorbic acid DIETARY_SUPPLEMENT

Ascorbic acid

ascorbic acid

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead

Study Sites (2)

Harokopio University

Athens, Attica, 17671, Greece

Location

Evgenidio Hospital

Athens, Greece

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Foods and Human Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: November 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)