Clinical trial NCT04029792: Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility
Official title: Pilot Study to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP028) on Joint Mobility, Physical Performance and Vitality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Joint Diseases
Keywords: Plant extract
Joint Mobility
Physical performance
Vitality
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
timeFrame: 8 weeks
Secondary outcomes:
measure: SF-36 Vitality score
timeFrame: 8 weeks
measure: Physical activity measurement
timeFrame: 8 weeks
Other outcomes:
measure: Evaluation of Knee Pain
timeFrame: 8 weeks
measure: Evaluation of Hip Pain
timeFrame: 8 weeks
measure: Timed Up and Go test
timeFrame: 8 weeks
measure: 30 sec Chair Stand test
timeFrame: 8 weeks
measure: Manual Dynamometry
timeFrame: 8 weeks
measure: Evaluation of Muscular power and fatigue of the lower limbs
timeFrame: 8 weeks
measure: Goniometric study
timeFrame: 8 weeks
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Helios Pareja Galeano
role: PRINCIPAL_INVESTIGATOR
References: