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

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ClinicalTrials.gov Identifier: NCT04029792
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

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.

Condition or disease Intervention/treatment Phase
Joint Diseases Combination Product: Combination of plant extracts (BSL_EP028) Combination Product: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
Experimental: Combination of Plant Extracts (BSL_EP028)
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)
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 Comparator: Placebo
Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin.
Combination Product: 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.




Primary Outcome Measures :
  1. Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test [ Time Frame: 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 Outcome Measures :
  1. SF-36 Vitality score [ Time Frame: 8 weeks ]
    Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality)

  2. Physical activity measurement [ Time Frame: 8 weeks ]
    Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week


Other Outcome Measures:
  1. Evaluation of Knee Pain [ Time Frame: 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

  2. Evaluation of Hip Pain [ Time Frame: 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

  3. Timed Up and Go test [ Time Frame: 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.

  4. 30 sec Chair Stand test [ Time Frame: 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.

  5. Manual Dynamometry [ Time Frame: 8 weeks ]
    Evaluates the grip strength of both hands

  6. Evaluation of Muscular power and fatigue of the lower limbs [ Time Frame: 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.

  7. Goniometric study [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029792


Contacts
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Contact: Ruth Blanco-Rojo +34913802973 ext 12521 rblanco@biosearchlife.com

Locations
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Spain
Universidad Europea de Madrid Recruiting
Villaviciosa de Odón, Madrid, Spain, 28670
Contact: Helios Pareja       helios.pareja@universidadeuropea.es   
Sponsors and Collaborators
Biosearch S.A.
Investigators
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Principal Investigator: Helios Pareja Galeano Universidad Europea de Madrid

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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT04029792     History of Changes
Other Study ID Numbers: C028
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosearch S.A.:
Plant extract
Joint Mobility
Physical performance
Vitality
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases