What side effects are associated with this type of intervention?

Common treatments involving the modulation of cytochrome P450 enzymes, such as those studied with cinnamon dietary supplements for CYP2A6 activity, can have various side effects. For instance, drugs that inhibit CYP2A6 may lead to increased levels of substrates metabolized by this enzyme, potentially causing toxicity. Side effects can include nausea, dizziness, and headaches. Conversely, inducers of CYP2A6 may reduce the efficacy of these substrates, leading to therapeutic failure. General side effects of CYP enzyme modulation can also include gastrointestinal disturbances, altered drug metabolism, and interactions with other medications, necessitating careful monitoring and dosage adjustments.

What prior FDA approvals exist?

The FDA has approved various drugs that modulate cytochrome P450 enzymes to manage drug-food interactions. These include medications that inhibit or induce specific CYP enzymes to alter the metabolism of co-administered drugs. For example, grapefruit juice is known to inhibit CYP3A4, affecting the metabolism of many drugs. While specific FDA approvals for treatments targeting CYP2A6 interactions are not detailed, the general approach involves using enzyme modulators to manage and mitigate adverse interactions between drugs and dietary components.

What other types of research exist?

Promising alternatives to cinnamon dietary supplements for modulating CYP2A6 enzyme activity include green tea and grapefruit. Green tea polyphenols have been shown to inhibit multiple cytochrome P450 enzymes, including CYP2A6, which could affect drug metabolism. Grapefruit contains furanocoumarins that inhibit CYP enzymes, including CYP2A6, and can significantly alter drug pharmacokinetics. Both options should be considered with caution and under medical supervision due to their potential to interact with various medications.

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Aromatase Inhibitor

Cinnamon for Drug-Food Interaction

Q: What is the mechanism of action of this treatment?

Common treatments for drug-food interactions often involve the modulation of cytochrome P450 enzymes, which play a critical role in drug metabolism. For instance, the cinnamon dietary supplement is being studied for its potential to modulate CYP2A6 enzyme activity. Such modulation can either inhibit or induce the enzyme, leading to changes in the metabolism of drugs that are CYP2A6 substrates. This is important for patients because altered enzyme activity can result in either increased toxicity or reduced efficacy of medications. Understanding these interactions helps in optimizing drug dosing and minimizing adverse effects, ensuring safer and more effective treatment outcomes.

Phase < 1

Waitlist Available

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking any medications or dietary/herbal supplements known to alter the pharmacokinetics of either study drug or cinnamon constituents

Be between 18 and 65 years old

Must not have

Any current major illness or chronic illness such as kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS

History of allergy to cinnamon, letrozole, or nicotine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-240 hours

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include those commonly associated with cinnamon consumption such as allergic reactions or digestive discomfort. Nicotine gum could cause mouth irritation or increased heart rate. Letrozole might lead to fatigue or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not taking any medications or supplements that affect how drugs or cinnamon work in my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

I am allergic to cinnamon, letrozole, or nicotine.

Select...

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

Select...

I have a history of anemia or other significant blood disorders.

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I am either younger than 18 or older than 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-240 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-240 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-240 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nicotine area under the concentration vs. time curve (AUC) ratio (exposure/baseline)

Secondary study objectives

Cinnamon constituent area under the concentration vs. time curve (AUC)

Cinnamon constituent half-life

Cinnamon constituent maximum concentration (Cmax)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for drug-food interactions often involve the modulation of cytochrome P450 enzymes, which play a critical role in drug metabolism. For instance, the cinnamon dietary supplement is being studied for its potential to modulate CYP2A6 enzyme activity. Such modulation can either inhibit or induce the enzyme, leading to changes in the metabolism of drugs that are CYP2A6 substrates. This is important for patients because altered enzyme activity can result in either increased toxicity or reduced efficacy of medications. Understanding these interactions helps in optimizing drug dosing and minimizing adverse effects, ensuring safer and more effective treatment outcomes.

Predicting clinical relevance of grapefruit-drug interactions: a complicated process.