Clinical trial NCT04506411: Turmeric Efficacy for Mobility and Joint Function
Official title: Placebo Controlled Randomized Clinical Trial to Evaluate Efficacy of Turmipure Gold® to Improve Joint Function in Subjects With Distinct Kellgren-Lawrence Knee Radiographic Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Discomfort
Joint Pain
Keywords: Mobility
Joint function
Turmeric
Curcuminoids
Lead sponsor: Givaudan France Naturals
Sponsor class: INDUSTRY
Collaborators: name: Artialis
name: Vizera d.o.o.
First posted: 2020-08-10
Enrollment: 177
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* Subject has a history of drug and / or alcohol abuse at the time of enrollment
* Change of dietary habit within the preceding month
* Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumor of intestine or colon and significant systemic disease
* Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
* Subject with known allergy to components of the test product
* Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
* History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
* Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives
* Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing)
* Who is taking any anticoagulant or heparin treatment

Primary outcomes:
measure: Change in WOMAC™ Pain
timeFrame: 12-weeks
Secondary outcomes:
measure: Change in WOMAC™ Stiffness
timeFrame: 12-weeks
measure: Change in WOMAC™ Physical function
timeFrame: 12-weeks
measure: Change in WOMAC™ Global Index
timeFrame: 12-weeks
measure: Pain intensity at rest
timeFrame: 12-weeks
measure: Pain intensity while walking
timeFrame: 12-weeks
measure: "Patient Global Assessment" (PGA)
timeFrame: 12-weeks
measure: OMERACT-OARSI criteria
timeFrame: 12-weeks
measure: 30s Chair Stand Physical Performance
timeFrame: 12-weeks
measure: 40m Fast-paced Walked Physical Performance
timeFrame: 12-weeks
measure: Stair Climb Physical Performance
timeFrame: 12-weeks
measure: Time up & Go Physical Performance
timeFrame: 12-weeks
measure: Quality of Life evaluation
timeFrame: 12-weeks
measure: Clinical Global Impression of Change (CGIC)
timeFrame: 12-weeks
measure: Assessment of use of rescue medicine
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Poliklinika Aviva
city: Zagreb
country: Croatia
facility: Poliklinika Idassa
city: Ankaran
country: Slovenia
facility: Ortopedska bolnišnica Valdoltra
city: Jesenice
country: Slovenia
facility: Splošna bolnišnica Jesenice, Oddelek za ortopedijo
city: Koper
country: Slovenia
facility: Bisturmed, d.o.o., Ortopedija in fizioterapija
city: Ljubljana
country: Slovenia
facility: Poliklinika Nobilis, d.o.o., enota LJ, Ortopedska ambulanta
city: Maribor
country: Slovenia
facility: Medicinsko termalni center Fontana, d.o.o., Ortopedska ambulanta
city: Maribor
country: Slovenia
facility: Univerzitetni klinični center Maribor, Oddelek za ortopedijo
Study officials:
affiliation: Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, Slovenia
name: Matija Tomšič, Prof., MD
role: STUDY_CHAIR
affiliation: Univerzitetni klinični center Maribor, Oddelek za ortopedijo
name: Samo K Fokter, MD
role: PRINCIPAL_INVESTIGATOR
References: