NCT03289507

Longvida Curcumin Human Pharmacokinetics Study

Longvida Curcumin Human Pharmacokinetics (PK) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to characterize the curcumin metabolites of 2 different capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes including assessing relative bioavailability and absorption/kinetic profile of curcumonoids and their metabolites in human plasma and urine after acute consumption.

Detailed description

This study is a randomized, 3-arm, double-blinded, within subject cross-over trial focused on understanding pharmacokinetic profile of curcuminoids and their metabolites after intake of curcumin supplement with different capsule formulations. A planned sample size of 6 will be enrolled into the study. This study will require one initial screening visit and 3 weekly visits. This study will take approximately 4 weeks per subject to complete. The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits. If willing and eligible to participate, subjects will be invited to participate in the study for 3 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration. Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive a curcumin supplement based on randomized treatment sequences for 3 study visits immediately after fasting blood draw. The sequences of receiving the supplement at each visit will be randomly assigned based on treatment sequences. Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 4, 6, and 8 hour (h) for assessment of change in plasma curcuminoids and metabolites. A standard breakfast will be provided immediately after the 0.5 h blood collection and standard lunch after 6 h blood collection. Urine samples will be collected at 0 (fasting), 4 and 8 h.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Treatment1	Longvida Capsule formulation A
DIETARY_SUPPLEMENT	Treatment2	Longvida Capsule formulation B
DIETARY_SUPPLEMENT	Treatment3	Curcuma longa extract of Rhizomes

Timeline

• Start date: 2017-09-19
• Primary completion: 2017-11-30
• Completion: 2018-01-30
• First posted: 2017-09-21
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States