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

NCT ID: NCT04029792

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-10-15

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.

Conditions

Joint Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Combination of plant extracts (BSL_EP028)

Intervention Type: COMBINATION_PRODUCT

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

Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biosearch S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helios Pareja Galeano

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ruth Blanco-Rojo

Role: CONTACT

rblanco@biosearchlife.com

+34913802973 ext. 12521

Facility Contacts

Helios Pareja

Role: primary

helios.pareja@universidadeuropea.es

Other Identifiers

C028

Identifier Type: -

Identifier Source: org_study_id