A Randomized, Double-Blinded, Comparator-Controlled, Crossover Study to Evaluate the Pharmacokinetics of Gaia Full-Spectrum Turmeric Phytocapsules

Gaia Herbs Inc.1 site in 1 country14 target enrollmentSeptember 24, 2022

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Gaia Herbs Inc.
Enrollment: 14
Locations: 1
Primary Endpoint: Pharmacokinetics- Peak plasma concentration (Cmax)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Turmeric is recognized as a bioactive compound with potential benefits for human health. This study compares the pharmacokinetic profile of the Turmeric test product to a comparator.

Detailed Description

This randomized, double-blinded, comparator-controlled, crossover study will compare the pharmacokinetic profile of the Turmeric test product to a comparator.

Registry

clinicaltrials.gov

Start Date

September 24, 2022

End Date

October 3, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Gaia Herbs Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult participants who are 18 to 49 years of age (inclusive).
•In good general health (no active or uncontrolled diseases or conditions) and is able to consume the study product.
•Have a body mass index between 18.5 to 24.9 kg/m2 (inclusive).
•Have normal or acceptable to the investigator heart rate at screening.
•Individuals with childbearing potential should have a negative pregnancy test at baseline and must agree to practice an acceptable form of non-hormonal birth control throughout the study, including but not limited to:
•double-barrier method
•non-hormonal intrauterine devices
•complete abstinence from sexual intercourse that can result in pregnancy
•vasectomy of partner at least 6 months prior to the first dose of study product Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
•Must have suitable veins for repeated venipuncture.

Exclusion Criteria

•Participants who are lactating, pregnant or planning to become pregnant during the study.
•Have a known sensitivity, intolerability, or allergy to any of the standardized study meals/snacks, study products or their excipients.
•Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis). Note: screened participants who have received a COVID-19 vaccine 2 weeks prior to screening would be eligible to participate after completing a 14-day washout period.
•Have uncontrolled or controlled high blood pressure (≥140 systolic or ≥90 diastolic mmHg) at screening.
•Have a history of heart disease/cardiovascular disease, renal or hepatic impairment/disease, diabetes (Type I or Type II), previously diagnosed or current diagnosis of any psychiatric disorders, unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study.
•Major surgery with general anesthesia in the 3 months prior to screening or planned major surgery during the course of the study.
•Have a history of blood clotting disorders.
•Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to the first pharmacokinetic visit or a blood donation of more than 450 mL within 56 days prior to the first pharmacokinetic visit.
•Reports donating plasma (e.g., plasmapheresis) within 15 days prior to the first pharmacokinetic visit.
•Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).

Outcomes

Primary Outcomes

Pharmacokinetics- Peak plasma concentration (Cmax)

Time Frame: 8 hours

Test products Peak plasma concentration (Cmax)

Pharmacokinetics- Time to reach Cmax (Tmax)

Time Frame: 8 hours

Test products Time to reach Cmax (Tmax)

Pharmacokinetics- Area under the plasma concentration-time curve for 8 hours (AUC0-8h)

Time Frame: 8 hours

Test products area under the plasma concentration-time curve for 8 hours (AUC0-8h)

Secondary Outcomes

Pharmacokinetics- Terminal elimination rate constant (Kel)(8 hours)
Pharmacokinetics- Half-life (T1/2)(8 hours)
Pharmacokinetics- Total area under the curve (observed from 0-8 hours, and extrapolated from 8 hours to infinity) [AUC(0-∞)](8 hours)
Safety- participants experiencing adverse events(8 days)
Safety- adverse events(8 days)