Longvida Curcumin Human Pharmacokinetics Study

NCT03289507 | Completed

• 1 other identifier: IRB2017-086
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Longvida Curcumin; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Changes in plasma curcumin metabolites among 3 different treatments

  Differences in plasma metabolites among 3 treatments

  8 hours Postprandial Study

Secondary Outcomes (1)

• Changes in urine metabolites among 3 different treatments

  8 hours Postprandial Study

Study Arms (3)

Treatment1

ACTIVE COMPARATOR

Longvida Capsule formulation A

Dietary Supplement: Treatment1

Treatment 2

ACTIVE COMPARATOR

Longvida Capsule formulation B

Dietary Supplement: Treatment2

Treatment3

EXPERIMENTAL

Curcuma longa extract of Rhizomes

Dietary Supplement: Treatment3

Interventions

Treatment1 DIETARY_SUPPLEMENT

Longvida Capsule formulation A

Treatment1

Treatment2 DIETARY_SUPPLEMENT

Longvida Capsule formulation B

Treatment 2

Treatment3 DIETARY_SUPPLEMENT

Curcuma longa extract of Rhizomes

Treatment3

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Verdure Sciences: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt M Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 21, 2017
• Study Start: September 19, 2017
• Primary Completion: November 30, 2017
• Study Completion: January 30, 2018
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)