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

Randomized, Double-blind, Controlled Nutritional Intervention Study of Parallel Groups to Evaluate the Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults

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.

Study Overview

• Status: Terminated
• Conditions: Knee Discomfort
• Intervention / Treatment: Dietary supplement: Dietary Supplement: Placebo; Dietary supplement: Dietary Supplement: EPP

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain
    • Universidad de Granada (Dpto. educación Física y Deportiva)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Control group that will receive two capsules with the maltodextrin per day during 12 weeks	Dietary supplement: Dietary Supplement: Placebo; 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
Experimental: EPP group; Experimental group that will receive two capsules with the bioactive compound per day during 12 weeks	Dietary supplement: Dietary Supplement: EPP; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS test total score.	Using of the KOOS (Knee Injury & Osteoarthritis Outcomes) Questionnaire.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).	Using the KOOS (Knee Injury & Osteoarthritis Outcomes) Questionnaire.	12 weeks
VPS scale for knee pain (general and after physical tests performed at the visits).	Using a Visual Pain Scale for Knee Pain	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.	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.	12 weeks
Changes observed between baseline and final MRI.	Analyzing cartilage by MRI	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.	12 weeks

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Collaborators: Universidad de Granada; University Hospital Virgen de las Nieves
• Investigators: Principal Investigator: Jonatan Ruiz Ruiz, Dr., Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: extract; bioactive compound
• Other Study ID Numbers: C030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No