Cinnamon for Drug-Food Interaction

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Washington State University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a cinnamon supplement on healthy volunteers to see how it affects drug metabolism. Cinnamon contains cinnamaldehyde, which can deactivate an enzyme that breaks down drugs, potentially making them stay in the body longer. Cinnamon has been used for thousands of years around the world and has shown various therapeutic effects including antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects.

Research Team

Eligibility Criteria

Healthy adults aged 18-64 who don't take medications or supplements that affect the study drugs, can avoid caffeine, alcohol, and certain contraceptives before and during the trial. They must not be pregnant or nursing and willing to use non-hormonal contraception.

Inclusion Criteria

I have the time to commit to this clinical trial.

Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study

Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of the first day of a study arm

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Exclusion Criteria

I have a major or chronic illness like kidney disease, heart issues, or diabetes.

I am allergic to cinnamon, letrozole, or nicotine.

I am not on medications that affect how study drugs or cinnamon work in my body.

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Treatment Details

Interventions

Cinnamon (Botanical Dietary Supplement)
Letrozole (Aromatase Inhibitor)
Nicotine gum (CYP2A6 Substrate)

Trial OverviewThe study tests how a cinnamon supplement affects the body's handling of nicotine gum and letrozole, which are used as test drugs to understand cinnamon's potential impact on drug metabolism in healthy volunteers.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: NicotineExperimental Treatment1 Intervention

Arm 2 will consist of administration of a single dose of nicotine gum (2 mg) to 16 subjects (8 biological men, 8 biological women). If these subjects participated in Arm 1, they will have completed a washout of 7 days since administration of cinnamon before starting Arm 2. Blood and urine will be collected from 0-12 hours relative to nicotine administration. Participants will undergo a washout of at least 4 days before beginning Arm 3.

Group II: LetrozoleExperimental Treatment1 Intervention

Arm 3 will consist of administration of a single oral dose of letrozole (2.5 mg) to the same 16 subjects who participate in Arm 2. Blood and urine will be collected from 0-240 hours and 0-24 hours, respectively, relative to letrozole administration. Participants will undergo a washout of at least 14 days before beginning Arm 4.

Group III: Cinnamon + NicotineExperimental Treatment2 Interventions

The same 16 subjects will self-administer the cinnamon product (2 g) three times daily for five consecutive days. On the sixth day, subjects will be administered cinnamon (2 g) and nicotine gum (2 mg). Cinnamon will be administered two additional times. Blood and urine will be collected from 0-12 hours relative to nicotine administration. Participants will undergo a washout of at least 4 days before beginning Arm 5.

Group IV: Cinnamon + LetrozoleExperimental Treatment2 Interventions

The same 16 subjects will self-administer the cinnamon product (2 g) three times daily for five consecutive days. On the sixth day, subjects will be administered cinnamon (2 g) and letrozole (2.5 mg). Cinnamon will be administered two additional times. Blood and urine will be collected from 0-240 hours and 0-24 hours, respectively, relative to letrozole administration.

Group V: CinnamonExperimental Treatment1 Intervention

Arm 1 will consist of administration of a single dose of cinnamon (2 g) with water by mouth to 6 subjects (3 biological men, 3 biological women). Blood will be drawn from 0-48 hours. Urine will be collected from 0-24 hours. The subjects may or may not elect to participate in Arms 2-5. If they do, a washout of at least 7 days will occur between Arm 1 administration of cinnamon and the Arm 2 administration of nicotine.

Letrozole is already approved in Canada for the following indications:

Approved in Canada as Letrozole for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer