Placebo Controlled Randomized Clinical Trial to Evaluate Efficacy of Turmipure Gold® to Improve Joint Function in Subjects With Distinct Kellgren-Lawrence Knee Radiographic Scores

Givaudan France Naturals8 sites in 2 countries177 target enrollmentSeptember 24, 2020

ConditionsKnee Discomfort Joint Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Discomfort
Sponsor: Givaudan France Naturals
Enrollment: 177
Locations: 8
Primary Endpoint: Change in WOMAC™ Pain
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort.

Detailed Description

The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the improvement of mobility and joint function in adult population with knee discomfort and with distinct Kellgren-Lawrence (K\&L) knee radiographic scores.

Registry

clinicaltrials.gov

Start Date

September 24, 2020

End Date

March 3, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Givaudan France Naturals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Consent to the study and to comply with study product
•Who have a BMI between 18 and 32 kg/m²
•Who has mild to moderate knee pain for at least 3 months before enrollment (VAS between 40 to 70 on 100mm scale after respecting a washout period depending on the half-life of the excluded medications)
•Who has radiographic evidence of Kellgren-Lawrence score 0, 1, 2 and 3 in the tibio-femoral compartment of the target knee
•Who is able to perform the physical performance-based tests and understands all questions from the WOMAC questionnaire
•Who is willing to refrain from taking any pain reliever (OTC or prescription) and other pharmacological, nutritional agent (e.g. glucosamine), device or therapy (e.g. acupuncture) which may influence the study outcome during the entire trial (other than determined authorized rescue medication)
•Who is willing to not change dietary habits, level of physical activity (including any heavy physical work with high loading of the knee joints) and body weight

Exclusion Criteria

•Subjects with any clinically significant levels of the safety parameters at screening
•Pregnant or lactating females, or wishing to become pregnant during the study
•Subject with joint pain related to some predisposing conditions that have adversely altered the joint tissues often due to a specific cause
•Subject with Kellgren-Lawrence grade 4 in the tibio-femoral compartment of the target knee
•Who has clinically apparent tense effusion of the target knee or other joint
•Who has/had viscosupplementation in any joint including the target knee or other joint within 6 months prior to screening
•Who has concomitant inflammatory disease or other condition that affects the joints deemed exclusionary by the Principal Investigator (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc...)
•Who has symptomatic osteoarthritis of the contralateral knee that is not responsive to paracetamol and requires other therapy
•Who is taking any treatment/supplementation which may interfere with study conduct and interpretation of study results (4-weeks washout, e.g. glucosamine, chondroitin, corticosteroids) except calcium and vitamin D supplements
•Who is under any medical condition deemed exclusionary by the Principal Investigator

Outcomes

Primary Outcomes

Change in WOMAC™ Pain

Time Frame: 12-weeks

Knee joint pain discomfort assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Pain subscore (WOMAC A) ranges from 0 to 100 mm (averaging five VAS 0-100 mm) with higher scores indicating more pain.