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Loss of the strategic interest because the market potential is insufficient
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| Name | Class |
|---|---|
| Universidad de Granada | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Control group that will receive two capsules with the maltodextrin per day during 12 weeks |
|
| EPP group | Experimental | Experimental group that will receive two capsules with the bioactive compound per day during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: Placebo | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS test total score. | Using of the KOOS (Knee Injury & Osteoarthritis Outcomes) Questionnaire. | 12 weeks |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonatan Ruiz Ruiz, Dr. | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Granada (Dpto. educación Física y Deportiva) | Granada | Spain |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement: EPP | 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 |
|
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 |