NCT04029792

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

May 13, 2020

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 22, 2019

Last Update Submit

May 12, 2020

Conditions

Joint Diseases

Keywords

Plant extractJoint MobilityPhysical performanceVitality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • SF-36 Vitality score

    8 weeks

  • Physical activity measurement

    8 weeks

Other Outcomes (7)

  • Evaluation of Knee Pain

    8 weeks

  • Evaluation of Hip Pain

    8 weeks

  • Timed Up and Go test

    8 weeks

  • +4 more other outcomes

Study Arms (2)

Combination of Plant Extracts (BSL_EP028)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Combination Product: Placebo

Interventions

Combination of plant extracts (BSL_EP028)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.

Combination of Plant Extracts (BSL_EP028)
PlaceboCOMBINATION_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

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women that have joint discomfort (WOMAC score \>20)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

RECRUITING

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Helios Pareja Galeano

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Blanco-Rojo

CONTACT

+34913802973rblanco@biosearchlife.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 23, 2019

Study Start

October 15, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

May 13, 2020

Record last verified: 2019-07

Locations

ES(1)