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Longvida Curcumin Human Pharmacokinetics Study (CRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289507
Recruitment Status : Active, not recruiting
First Posted : September 21, 2017
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 21, 2017
Last Update Posted Date May 27, 2019
Actual Study Start Date  ICMJE September 19, 2017
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
Changes in plasma curcumin metabolites among 3 different treatments [ Time Frame: 8 hours Postprandial Study ]
Differences in plasma metabolites among 3 treatments
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03289507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
Changes in urine metabolites among 3 different treatments [ Time Frame: 8 hours Postprandial Study ]
Differences in urine metabolites among 3 treatments
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Longvida Curcumin Human Pharmacokinetics Study
Official Title  ICMJE Longvida Curcumin Human Pharmacokinetics (PK) Study
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Treatment1
    Longvida Capsule formulation A
  • Dietary Supplement: Treatment2
    Longvida Capsule formulation B
  • Dietary Supplement: Treatment3
    Curcuma longa extract of Rhizomes
Study Arms  ICMJE
  • Active Comparator: Treatment1
    Longvida Capsule formulation A
    Intervention: Dietary Supplement: Treatment1
  • Active Comparator: Treatment 2
    Longvida Capsule formulation B
    Intervention: Dietary Supplement: Treatment2
  • Experimental: Treatment3
    Curcuma longa extract of Rhizomes
    Intervention: Dietary Supplement: Treatment3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2017)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2022
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Men or women, 20-45 years of age with body mass index (BMI) in range from 18.5 to 24.9 kg/m2

    • Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years)
    • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease that may interfere with study outcomes
    • Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, gastrointestinal medications, antibiotics, anti-inflammatory drugs, dietary supplements including fiber supplements, prebiotics and probiotics, etc.
    • Able to provide informed consent
    • Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood and urine sample collection procedures and study visit schedule)
    • Minimum weight of 45 kg

Exclusion Criteria:

  • Men and women who smoke

    • Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
    • Men and women known to have/diagnosed with diabetes mellitus
    • Men and women who have fasting blood glucose concentrations > 125 mg/dL
    • Men and women who have uncontrolled blood pressure >160 mmHg (systolic) or 100 mmHg (diastolic)
    • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
    • Men and women with cancer other than non-melanoma skin cancer in previous 5 years
    • Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
    • Women who are known to be pregnant (pregnancy test will be completed for female subjects) or who are intending to become pregnant over the course of the study
    • Women who are lactating
    • Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
    • Men and women who has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
    • Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
    • Men and women who are vegans
    • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
    • Substance (alcohol or drug) abuse within the last 2 years
    • Excessive coffee and tea consumers (> 5 cups/day)
    • Men and women who do excessive exercise regularly or athlete
    • Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
    • Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
    • Unusual working hours i.e., working overnight (e.g. 3rd shift)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289507
Other Study ID Numbers  ICMJE IRB2017-086
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute for Food Safety and Health, United States
Study Sponsor  ICMJE Institute for Food Safety and Health, United States
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Britt M Burton-Freeman, Ph.D Illinois Institute of Technology
PRS Account Institute for Food Safety and Health, United States
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP