Longvida Curcumin Human Pharmacokinetics Study
Condition: Healthy
Study type: Interventional

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.
    

Intervention name(s): Treatment1; Treatment2; Treatment3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Longvida Capsule formulation A; Longvida Capsule formulation B; Curcuma longa extract of Rhizomes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Longvida Curcumin; Pharmacokinetics