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

Joint Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029792
• Other study ID #: C028
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 15, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: Ruth Blanco-Rojo
• Phone: +34913802973
• Email: rblanco[@]biosearchlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases

Intervention

Combination Product:
• Combination 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.
• Placebo
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.

Locations

Country	Name	City	State
Spain	Universidad Europea de Madrid	Villaviciosa de Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	8 weeks
Other	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
Other	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
Other	Manual Dynamometry	Evaluates the grip strength of both hands	8 weeks
Other	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
Other	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
Primary	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	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
Secondary	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