Clinical trial NCT06650670: Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Discomfort
Keywords: extract
bioactive compound
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Granada
name: University Hospital Virgen de las Nieves
First posted: 2024-10-21
Enrollment: 37
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: KOOS test total score.
timeFrame: 12 weeks
Secondary outcomes:
measure: KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).
timeFrame: 12 weeks
measure: VPS scale for knee pain (general and after physical tests performed at the visits).
timeFrame: 12 weeks
measure: Objective assessment of physical activity.
timeFrame: 12 weeks
measure: Range of motion of the knee joint.
timeFrame: 12 weeks
measure: Changes observed between baseline and final MRI.
timeFrame: 12 weeks
measure: Lower body strength and power.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada (Dpto. educación Física y Deportiva)
Study officials:
affiliation: Universidad de Granada
name: Jonatan Ruiz Ruiz, Dr.
role: PRINCIPAL_INVESTIGATOR
References: