Cinnamon for Drug-Food Interaction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how cinnamon, a common spice, might affect the way certain drugs work in healthy individuals. Researchers seek to understand whether cinnamon alters the body's processing of letrozole, a cancer medication, and nicotine gum, used to aid smoking cessation. The goal is to explore cinnamon's potential as a smoking cessation aid and its impact on letrozole treatment. Healthy individuals not taking any medications or supplements and who can avoid certain foods and drinks for a period are ideal candidates for this study. As an Early Phase 1 trial, this research focuses on how cinnamon interacts with these drugs, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications or supplements that could affect the study drugs or cinnamon. The trial requires participants to not take any such medications or supplements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cinnamon might affect how the body processes certain medications. One study found that compounds in cinnamon, such as cinnamaldehyde, could slow the breakdown of drugs in the body. This might alter the effectiveness of these drugs or extend their presence in the system.
Nicotine gum is generally safe when used properly. However, combining it with other substances, like cinnamon, might cause side effects such as an increased heart rate.
Letrozole, a medication commonly used to treat breast cancer, has received FDA approval, indicating it has undergone safety testing in humans.
This trial is in its early phase, meaning researchers are still gathering initial safety information. This phase typically involves a small group of participants to learn more about side effects and how the body processes the treatment. So far, no major safety issues have been reported, but further studies are needed to confirm this.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores how cinnamon might affect drug-food interactions, specifically with letrozole and nicotine gum. Unlike standard treatments, which typically focus on the drug alone, this study investigates whether cinnamon can influence how the body processes these compounds. Cinnamon is a natural product that might alter drug absorption or metabolism, potentially leading to new ways to enhance drug effectiveness or reduce side effects. By examining these interactions, scientists hope to uncover novel insights that could optimize how medications are used in combination with certain foods or supplements.
What evidence suggests that this trial's treatments could be effective?
Research has shown that cinnamon can affect how the body processes certain drugs. This trial involves participants in different arms to study these effects. One arm investigates how cinnamon, when combined with letrozole, might alter the breakdown of letrozole in the body. Another arm explores the interaction between cinnamon and nicotine gum, examining how cinnamon might influence nicotine metabolism. These findings suggest that cinnamon could help people stop smoking and might affect how some drugs function in the body.12467
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cinnamon Administration
Participants receive a single dose of cinnamon (2 g) with water by mouth
Nicotine Administration
Participants receive a single dose of nicotine gum (2 mg)
Cinnamon + Letrozole Administration
Participants self-administer cinnamon (2 g) three times daily for five days, followed by cinnamon and letrozole (2.5 mg) on the sixth day
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cinnamon
- Letrozole
- Nicotine gum
Trial Overview
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.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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 United States, European Union, Canada for the following indications:
- Breast cancer in postmenopausal women
- Increasing the chance of ovulation in women with polycystic ovary syndrome
- Early breast cancer in postmenopausal women
- Advanced breast cancer in postmenopausal women
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington State University
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Office of Dietary Supplements (ODS)
Collaborator
Published Research Related to This Trial
Citations
Mechanisms of Herb-Drug Interactions Involving Cinnamon ...
Mechanisms of herb-drug interactions involving cinnamon and CYP2A6: focus on time-dependent inhibition by Cinnamaldehyde and 2-Methoxycinnamaldehyde.
Cinnamon for Drug-Food Interaction · Info for Participants
Studies show it can effectively help reduce smoking with minimal discomfort or risk of relapse, and it avoids harmful substances found in cigarette smoke like ...
Cinnamon Could Affect Drug Metabolism in the Body
A new study from the National Center for Natural Products Research indicates a compound in it could interfere with some prescription medications.
Natural Products: Experimental Approaches to Elucidate ...
This special issue contains a collection of articles highlighting the challenges faced by researchers in the field and the use of various experimental systems ...
Mechanisms of Herb-Drug Interactions Involving Cinnamon ...
Predictions regarding herb-drug interactions suggest that prolonged exposure to cinnamon may result in significant interactions, particularly with nicotine [ ...
Cinnamon Interactions Checker
Does cinnamon interact with my other drugs? Enter medications to view a detailed interaction report using our Drug Interaction Checker.
Cinnamon could interact with some prescription ...
People should be cautious because cinnamon could affect the metabolism of prescription drugs, according to a study published in the journal Food Chemistry: ...
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