A measurement study of blood concentration after curcumin consumption: a randomized, active-controlled, double-blind, crossover comparison study

UMIN ID: UMIN000056343

Registered date:03/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/12/03
• Target sample size: 8
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

<Duration> Single ingestion <Test food> Period I: Curcumin-containing food 1 Period II: Curcumin-containing food 2 Period III: Curcumin-containing food 3 Period IV: Curcumin-containing food 4 *The intervention sequence is from Period I to Period IV. *The washout period is at least one week.
<Duration> Single ingestion <Test food> Period I: Curcumin-containing food 2 Period II: Curcumin-containing food 3 Period III: Curcumin-containing food 4 Period IV: Curcumin-containing food 1 *The intervention sequence is from Period I to Period IV. *The washout period is at least one week.
<Duration> Single ingestion <Test food> Period I: Curcumin-containing food 3 Period II: Curcumin-containing food 4 Period III: Curcumin-containing food 1 Period IV: Curcumin-containing food 2 *The intervention sequence is from Period I to Period IV. *The washout period is at least one week.
<Duration> Single ingestion <Test food> Period I: Curcumin-containing food 4 Period II: Curcumin-containing food 1 Period III: Curcumin-containing food 2 Period IV: Curcumin-containing food 3 *The intervention sequence is from Period I to Period IV. *The washout period is at least one week.

Outcome(s)

• Primary Outcome: The blood concentration of curcumin, area under the curve (AUC), maximum blood concentration (Cmax), and time to maximum blood concentration (Tmax)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, hemochromatosis, biliary tract disease, or any other chronic diseases 4. Individuals who have impaired liver function or are suspected of having liver dysfunction 5. Individuals who have a medical history of liver disease or bile duct atresia 6. Individuals who are undergoing treatment for gastric ulcers, gastric hyperacidity, bile duct disorder, or gallstones 7. Individuals who are undergoing treatment with anticoagulants, anticancer agents, or immunosuppressive agents 8. Individuals who regularly consume iron-rich foods 9. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 10. Individuals who are taking or using medications (including herbal medicines) or supplements 11. Individuals who regularly consume foods or beverages containing curcumin 12. Individuals who are allergic to medicines or foods related to the test product 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. Individuals who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: San-Ei Gen F. F. I., Inc.