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

Biosearch Life

Status: Terminated

Conditions: Knee Discomfort

Treatments: Dietary Supplement: Dietary Supplement: Placebo; Dietary Supplement: Dietary Supplement: EPP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06650670

C030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Control group that will receive two capsules with the maltodextrin per day during 12 weeks

Treatment:

Dietary Supplement: Dietary Supplement: Placebo

EPP group

Experimental group

Description:

Experimental group that will receive two capsules with the bioactive compound per day during 12 weeks

Treatment:

Dietary Supplement: Dietary Supplement: EPP