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

Pilot Study to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP028) on Joint Mobility, Physical Performance and Vitality

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.

Study Overview

• Status: Unknown
• Conditions: Joint Diseases
• Intervention / Treatment: Combination product: Placebo; Combination product: Combination of plant extracts (BSL_EP028)

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Villaviciosa de Odón, Madrid, Spain, 28670
      • Recruiting
      • Universidad Europea de Madrid
      • Contact: Helios Pareja; Email: helios.pareja@universidadeuropea.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Manual Dynamometry	Evaluates the grip strength of both hands	8 weeks
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
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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Helios Pareja Galeano, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): October 15, 2020
• Study Completion (Anticipated): October 15, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Physical performance; Plant extract; Vitality; Joint Mobility
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: C028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No