Joint Diseases
Conditions
Keywords
Plant extract, Joint Mobility, Physical performance, Vitality
Brief summary
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
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.
Interventions
COMBINATION_PRODUCTCombination of plant extracts (BSL_EP028)
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.
COMBINATION_PRODUCTPlacebo
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.
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test | 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Vitality score | 8 weeks | Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality) |
| Physical activity measurement | 8 weeks | Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week |
Other
| Measure | Time frame | Description |
|---|---|---|
| 30 sec Chair Stand test | 8 weeks | 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. |
| Manual Dynamometry | 8 weeks | Evaluates the grip strength of both hands |
| Evaluation of Knee Pain | 8 weeks | Knee pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
| Goniometric study | 8 weeks | Evaluates the angles and ranges of movement of the hip joint (flexo-extension, abduction-adduction, internal-external rotation) and the femorotibial (flexo-extension). |
| Evaluation of Muscular power and fatigue of the lower limbs | 8 weeks | 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. |
| Evaluation of Hip Pain | 8 weeks | Hip pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
| Timed Up and Go test | 8 weeks | 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. |
Countries
Spain
Contacts
Primary ContactRuth Blanco-Rojo
Outcome results
None listed