Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults

Biosearch S.A.37 enrolled

Overview

The objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort.

It is estimated that the incidence of osteoarthritis (OA) is increasing exponentially worldwide, with serious consequences, not only on the quality of life and functionality of the subjects, but also a high burden on the social and health care systems of the countries. Existing treatments for OA are either invasive, and therefore risky for the subject and high cost, or have side effects and cannot be maintained over time. Therefore, there is a high demand to find effective and safe therapies to prevent and/or treat OA, such as functional ingredients or compounds present in food. In this regard, our experimental bioactive compound has been developed and shown to be safe and effective in reducing joint pain and improving quality of life in a previous study. The aim of this study is to evaluate the effect of the consumption of our bioactive compound, in healthy Spanish individuals with mild joint discomfort in the knee.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Knee Discomfort

Interventions

Dietary Supplement: PlaceboDIETARY_SUPPLEMENT

Each participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits

Dietary Supplement: EPPDIETARY_SUPPLEMENT

Each participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy participants (men and women) between 35 and 65 years of age with knee discomfort. 2. Mild knee joint pain (visual analog scale between 3 and 6 cm). Exclusion Criteria: 1. People with clinical osteoarthritis or any other degenerative joint disease. 2. Persons receiving treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, HA, diacerein) two weeks prior to screening. 3. Persons receiving intra-articular injections in the knee joint in the 3 months prior to the study.

Locations (1)

Universidad de Granada (Dpto. educación Física y Deportiva)

Granada, Spain

Outcomes

Primary Outcomes

KOOS test total score.

Using of the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.

Time frame: 12 weeks

Secondary Outcomes

KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).

Using the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.

Time frame: 12 weeks

VPS scale for knee pain (general and after physical tests performed at the visits).

Using a Visual Pain Scale for Knee Pain

Time frame: 12 weeks

Objective assessment of physical activity.

The mobility of your knee will be assessed with a goniometer, the sit-to-stand test will be performed, and accelerometers will be collected to assess physical activity and sedentary lifestyle.

Time frame: 12 weeks

Range of motion of the knee joint.

The mobility of your knee will be assessed with a goniometer, the sit-to-stand test will be performed, and accelerometers will be collected to assess physical activity and sedentary lifestyle.

Time frame: 12 weeks

Changes observed between baseline and final MRI.

Analyzing cartilage by MRI

Time frame: 12 weeks

Lower body strength and power.

The mobility of your knee will be assessed with a goniometer, the sit-to-stand test will be performed, and accelerometers will be collected to assess physical activity and sedentary lifestyle.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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