Turmeric Efficacy for Mobility and Joint Function

NCT ID: NCT04506411

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2023-03-03

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.

Conditions

Knee Discomfort; Joint Pain

Study Design

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

Study Groups

TPG

59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 12 weeks

Group Type: EXPERIMENTAL

Turmipure GOLD®

Intervention Type: DIETARY_SUPPLEMENT

TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed

STE

59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive standard turmeric extract 95% curcuminoids (STE) product during 12 weeks

Group Type: ACTIVE_COMPARATOR

Turmeric rhizome PE 95% curcuminoids

Intervention Type: DIETARY_SUPPLEMENT

STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed

Control

59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (maltodextrin) product during 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo: Maltodextrin - 4 capsules once daily- as prescribed

Interventions

Turmipure GOLD®

TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed

Intervention Type: DIETARY_SUPPLEMENT

Turmeric rhizome PE 95% curcuminoids

STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo: Maltodextrin - 4 capsules once daily- as prescribed

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Artialis

INDUSTRY

Sponsor Role: collaborator

Vizera d.o.o.

INDUSTRY

Sponsor Role: collaborator

Givaudan France Naturals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matija Tomšič, Prof., MD

Role: STUDY_CHAIR

Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, Slovenia

Samo K Fokter, MD

Role: PRINCIPAL_INVESTIGATOR

Univerzitetni klinični center Maribor, Oddelek za ortopedijo

Locations

Poliklinika Aviva

Zagreb, , Croatia

Poliklinika Idassa

Zagreb, , Croatia

Ortopedska bolnišnica Valdoltra

Ankaran, , Slovenia

Splošna bolnišnica Jesenice, Oddelek za ortopedijo

Jesenice, , Slovenia

Bisturmed, d.o.o., Ortopedija in fizioterapija

Koper, , Slovenia

Poliklinika Nobilis, d.o.o., enota LJ, Ortopedska ambulanta

Ljubljana, , Slovenia

Medicinsko termalni center Fontana, d.o.o., Ortopedska ambulanta

Maribor, , Slovenia

Univerzitetni klinični center Maribor, Oddelek za ortopedijo

Maribor, , Slovenia

Countries

Croatia; Slovenia

Other Identifiers

0120-118/2020/9

Identifier Type: -

Identifier Source: org_study_id