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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Plant Extracts (BSL_EP028) | Experimental | Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) |
|
| Placebo | Placebo Comparator | Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of plant extracts (BSL_EP028) | Combination Product | 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. |
| 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:
| 8 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Knee Pain | Knee pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain | 8 weeks |
| Evaluation of Hip Pain | Hip pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Blanco-Rojo | Contact | +34913802973 | 12521 | rblanco@biosearchlife.com |
| Name | Affiliation | Role |
|---|---|---|
| Helios Pareja Galeano | Universidad Europea de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrid | Recruiting | Villaviciosa de Odón | Madrid | 28670 | Spain |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| Placebo | Combination Product | 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. |
|
| 8 weeks |
| 8 weeks |
| Timed Up and Go test | This test evaluates mobility and balance by measuring the time it takes a person to get up from a chair, walk three meters, turn around, walk to the chair, and sit. | 8 weeks |
| 30 sec Chair Stand test | This test evaluates the strength and endurance of the lower limbs by measuring the number of times a person can get up from a chair, with arms crossed at the chest, for 30 seconds. | 8 weeks |
| Manual Dynamometry | Evaluates the grip strength of both hands | 8 weeks |
| Evaluation of Muscular power and fatigue of the lower limbs | We evaluate the strength-velocity profile that the person has in the lower limbs through a linear encoder. It measures the speed of execution of a squat (extension of hips and knees) with three different loads. | 8 weeks |
| Goniometric study | Evaluates the angles and ranges of movement of the hip joint (flexo-extension, abduction-adduction, internal-external rotation) and the femorotibial (flexo-extension). | 8 weeks |