Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility
Primary Purpose
Joint Diseases
Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Combination of plant extracts (BSL_EP028)
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Joint Diseases focused on measuring Plant extract, Joint Mobility, Physical performance, Vitality
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.
Sites / Locations
- Universidad Europea de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Combination of Plant Extracts (BSL_EP028)
Placebo
Arm Description
Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028)
Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
SF-36 Vitality score
Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality)
Physical activity measurement
Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04029792
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
October 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Diseases
Keywords
Plant extract, Joint Mobility, Physical performance, Vitality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combination of Plant Extracts (BSL_EP028)
Arm Type
Experimental
Arm Description
Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin.
Intervention Type
Combination Product
Intervention Name(s)
Combination of plant extracts (BSL_EP028)
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
SF-36 Vitality score
Description
Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality)
Time Frame
8 weeks
Title
Physical activity measurement
Description
Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Evaluation of Knee Pain
Description
Knee pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain
Time Frame
8 weeks
Title
Evaluation of Hip Pain
Description
Hip pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain
Time Frame
8 weeks
Title
Timed Up and Go test
Description
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.
Time Frame
8 weeks
Title
30 sec Chair Stand test
Description
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.
Time Frame
8 weeks
Title
Manual Dynamometry
Description
Evaluates the grip strength of both hands
Time Frame
8 weeks
Title
Evaluation of Muscular power and fatigue of the lower limbs
Description
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.
Time Frame
8 weeks
Title
Goniometric study
Description
Evaluates the angles and ranges of movement of the hip joint (flexo-extension, abduction-adduction, internal-external rotation) and the femorotibial (flexo-extension).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Blanco-Rojo
Phone
+34913802973
Ext
12521
Email
rblanco@biosearchlife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helios Pareja Galeano
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Europea de Madrid
City
Villaviciosa de Odón
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helios Pareja
Email
helios.pareja@universidadeuropea.es
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility
We'll reach out to this number within 24 hrs