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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

Dietary Supplement: Placebo

Intervention Type DIETARY_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

EPP group

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

Group Type EXPERIMENTAL

Dietary Supplement: EPP

Intervention Type DIETARY_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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes