Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility

Study Overview
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Brief Summary
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The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.

Detailed Description
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The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care. For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.

Official Title
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Pilot Study to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP028) on Joint Mobility, Physical Performance and Vitality

Conditions
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Joint Diseases

Intervention / Treatment
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* Combination Product: Combination of plant extracts (BSL_EP028)
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women that have joint discomfort (WOMAC score >20) Exclusion Criteria: Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations). Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist Consuming nutritional supplements containing antioxidant substances Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain. Being unable to perform the physical tests required in the study. Have an allergy to some component of the study product.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of Plant Extracts (BSL_EP028)<br>Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) | Combination Product: Combination of plant extracts (BSL_EP028)<br>* Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.<br>|
| Placebo Comparator: Placebo<br>Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin. | Combination Product: Placebo<br>* Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test | It is a questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items) Stiffness (2 items) Physical Function (17 items) The higher the score, the higher the amount of pain, stiffness, and a high level of functional limitations | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Vitality score | Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality) | 8 weeks | 
| Physical activity measurement | Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant extract, Joint Mobility, Physical performance, Vitality