Knee Discomfort
Conditions
Keywords
extract, bioactive compound
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.
Interventions
DIETARY_SUPPLEMENTDietary 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
DIETARY_SUPPLEMENTDietary 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
Sponsors
Universidad de Granada
University Hospital Virgen de las Nieves
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS test total score. | 12 weeks | Using of the KOOS (Knee Injury & Osteoarthritis Outcomes) Questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life). | 12 weeks | Using the KOOS (Knee Injury & Osteoarthritis Outcomes) Questionnaire. |
Countries
Spain
Outcome results
None listed