The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Symptomatic Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ascorbic acid / phytochemical supplement

A mixture of active phenolic compounds with ascorbic acid

Group Type EXPERIMENTAL

Ascorbic acid / phytochemical supplement

Intervention Type DIETARY_SUPPLEMENT

Ascorbic acid / phytochemical supplement

ascorbic acid

Ascorbic acid group

Group Type EXPERIMENTAL

Ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

Ascorbic acid

Interventions

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Ascorbic acid / phytochemical supplement

Intervention Type DIETARY_SUPPLEMENT

Ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No