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

Phase 1

• Conditions: Joint Diseases
• Interventions: Combination Product: Combination of plant extracts (BSL_EP028); Combination Product: Placebo

• Registration Number: NCT04029792
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Study Start: 2019-10-15
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of Plant Extracts (BSL_EP028)	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)
Placebo	Placebo	Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Universidad Europea de Madrid; 🇪🇸 Villaviciosa de Odón, Madrid, Spain