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

Not Applicable

Terminated

• Conditions: Knee Discomfort

• Registration Number: NCT06650670
• Lead Sponsor: Biosearch S.A.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
KOOS test total score.	12 weeks	Using of the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.

Secondary Outcome Measures

Name	Time	Method
KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).	12 weeks	Using the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.
VPS scale for knee pain (general and after physical tests performed at the visits).	12 weeks	Using a Visual Pain Scale for Knee Pain
Objective assessment of physical activity.	12 weeks	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.
Range of motion of the knee joint.	12 weeks	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.
Changes observed between baseline and final MRI.	12 weeks	Analyzing cartilage by MRI
Lower body strength and power.	12 weeks	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.

Trial Locations

Locations (1)

Universidad de Granada (Dpto. educación Física y Deportiva); 🇪🇸 Granada, Spain