Interaction Drug FoodEarly Phase 1NCT05157672
Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon
A Early Phase 1 study testing Cinnamon (2 g), Nicotine gum (2.5 mg) and Letrozole (2.5 mg) in people with Interaction Drug Food, run by Washington State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a well-characterized, commercially available cinnamon dietary supplement as a precipitant of pharmacokinetic interactions with cytochrome P450 (CYP) 2A6 drug substrates in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Interaction Drug Food
- What is being tested?
- Cinnamon (2 g), Nicotine gum (2.5 mg) and Letrozole (2.5 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 31 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, aged from 18-64 years and healthy
- Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of either study drug or cinnamon constituents
- Willing to abstain from consuming dietary/herbal supplements and citrus juices for several weeks
- 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
- Willing to abstain from consuming any alcoholic beverages for one day prior to any study day, during the 14-hour inpatient days, and for the outpatient visit(s) following the 14-hour visit
- Willing to use an acceptable method of contraception that does not include oral contraceptive pills or patches (such as abstinence, copper IUD, condom)
- Have the time to participate
- 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
Who cannot join
- Under the age of 18 or 65+ years
- Any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
- History of anemia or any other significant hematologic disorder
- History of drug or alcohol addiction or major psychiatric illness
- Pregnant or nursing
- History of allergy to cinnamon, letrozole, or nicotine
Show all 11Show fewer
- Taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products), known to alter the pharmacokinetics of either study drug or cinnamon constituents
- Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
- Recreational drug use such as amphetamines, benzodiazepines, cocaine, marijuana, MDMA, opioids, and PCP
- History of intolerance to cinnamon
- Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, 99202
About this study
The purpose of this study is to evaluate a well-characterized, commercially available cinnamon dietary supplement as a precipitant of pharmacokinetic interactions with cytochrome P450 (CYP) 2A6 drug substrates in healthy volunteers. Nicotine gum will be used as the CYP2A6 probe drug (i.e., positive control) and letrozole as a high-impact object drug. Results will be used to inform future research on the potential use of cinnamon as a smoking cessation agent, as well as the clinical impact on pharmacotherapeutic regimens involving letrozole in cancer patients.
Read the detailed description
Cinnamon is used worldwide as both an additive and a botanical dietary supplement, the latter of which ranked within the 30 top-selling herbal supplements in 2020. Cinnamon is added to a variety of products, ranging from foods (e.g., breakfast cereals, baked goods) to fragrances and essential oils, to improve taste or smell. As a dietary supplement, cinnamon is commonly used to lower blood sugar and reduce inflammation. Cinnamon contains the abundant component, cinnamaldehyde (CA), a phenylpropanoid that emanates the flavor and scent of cinnamon. Research by Harrelson and colleagues has shown CA to inhibit the drug metabolizing enzyme cytochrome P450 (CYP) 2A6 in a time-dependent manner. That is, CYP2A6 metabolizes CA to a reactive intermediate that destroys the enzyme. Such substrates are also referred to as "suicide substrates". This type of enzyme inhibition is similar to that of grapefruit juice, which contains furanocoumarins that are time-dependent inhibitors of CYP3A in the intestine, leading to numerous potential adverse interactions with drugs metabolized by CYP3A. Unlike competitive inhibitors, time-dependent inhibitors inactivate the enzyme permanently, requiring de novo synthesis of the enzyme. As such, drug interactions with time-dependent inhibitors can last for several days. Relative to CYP3A, the list of clinically relevant CYP2A6 substrates is very short. However, two critical substrates include nicotine and the anticancer agent letrozole. Using an in vitro-to-in vivo extrapolation approach, CA was predicted to increase the area under the plasma concentration vs. time curve (AUC) of both substrates by 4- to 5-fold exceeding the FDA recommended cutoff (1.25) These compelling observations prompted this clinical study.
- Conditions
- Interaction Drug Food
- Being tested
- Cinnamon (2 g), Nicotine gum (2.5 mg), Letrozole (2.5 mg)
- Keywords
- pharmacokinetics, interaction, cinnamon, letrozole, nicotine, cinnamaldehyde, cinnamomum verum, natural product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon (2 g)Dietary supplement
oral capsules, 2 g
Nicotine gum (2.5 mg)Drug
Also called Nicorette
gum, 2.5 mg
Letrozole (2.5 mg)Drug
Also called Femara
tablet, 2.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon | Experimental | Arm 1 will consist of administration of a single dose of cinnamon (2 g) with water by mouth to 6 subjects (3 males, 3 females). 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. Receives: Dietary Supplement: Cinnamon (2 g) |
| Nicotine | Experimental | Arm 2 will consist of administration of a single dose of nicotine gum (2 mg) to 16 subjects. 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. Receives: Drug: Nicotine gum (2.5 mg) |
| Letrozole | Experimental | 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. Receives: Drug: Letrozole (2.5 mg) |
| Cinnamon + Nicotine | Experimental | 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. Receives: Dietary Supplement: Cinnamon (2 g); Drug: Nicotine gum (2.5 mg) |
| Cinnamon + Letrozole | Experimental | 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. Receives: Dietary Supplement: Cinnamon (2 g); Drug: Letrozole (2.5 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine AUC
Nicotine Area Under the Curve alone and in the presence of cinnamon
Measured: 0-12h
Secondary outcomes (5)
Letrozole AUC
Letrozole Area Under the Curve alone and in the presence of cinnamon
Measured: 0-240h
Letrozole Cmax
Letrozole maximum concentration alone and in the presence of cinnamon
Measured: 0-240h
Nicotine Half Life
Nicotine half life alone and in the presence of cinnamon
Measured: 0-12h
Nicotine Cmax
Nicotine maximum concentration alone and in the presence of cinnamon
Measured: 0-12h
Letrozole Half Life
Letrozole half life alone and in the presence of cinnamon
Measured: 0-240h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start14 Dec 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Interaction Drug FoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mary Paine, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157672
- Sponsor's protocol ID
- 18686
- Other IDs
- U54AT008909
- Status last verified
- Nov 2026
- First submitted
- 1 Dec 2021
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith T, Majid F, Eckl V, and Reynolds CM (2021) Herbal Supplement Sales in US Increase by Record-Breaking 17.3% in 2020. HerbalGram 131:52-65.
Leach MJ, Kumar S. Cinnamon for diabetes mellitus. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007170. doi: 10.1002/14651858.CD007170.pub2.
PubMed 22972104Chan J, Oshiro T, Thomas S, Higa A, Black S, Todorovic A, Elbarbry F, Harrelson JP. Inactivation of CYP2A6 by the Dietary Phenylpropanoid trans-Cinnamic Aldehyde (Cinnamaldehyde) and Estimation of Interactions with Nicotine and Letrozole. Drug Metab Dispos. 2016 Apr;44(4):534-43. doi: 10.1124/dmd.115.067942. Epub 2016 Feb 5.
PubMed 26851241Espiritu MJ, Chen J, Yadav J, Larkin M, Pelletier RD, Chan JM, Gc JB, Natesan S, Harrelson JP. Mechanisms of Herb-Drug Interactions Involving Cinnamon and CYP2A6: Focus on Time-Dependent Inhibition by Cinnamaldehyde and 2-Methoxycinnamaldehyde. Drug Metab Dispos. 2020 Oct;48(10):1028-1043. doi: 10.1124/dmd.120.000087. Epub 2020 Aug 12.
PubMed 32788161FDA (2020) Drug Interactions: Relevant Regulatory Guidance and Policy Documents
Paine MF, Shen DD, McCune JS. Recommended Approaches for Pharmacokinetic Natural Product-Drug Interaction Research: a NaPDI Center Commentary. Drug Metab Dispos. 2018 Jul;46(7):1041-1045. doi: 10.1124/dmd.117.079962. Epub 2018 May 7.
PubMed 29735755
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon
- ClinicalTrials.gov ID
- NCT05157672
- Acronym / sponsor ID
- 18686
- Conditions
- Interaction Drug Food
- Keywords
- pharmacokinetics, interaction, cinnamon, letrozole, nicotine, cinnamaldehyde, cinnamomum verum, natural product
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a well-characterized, commercially available cinnamon dietary supplement as a precipitant of pharmacokinetic interactions with cytochrome P450 (CYP) 2A6 drug substrates in healthy volunteers. Nicotine gum will be used as the CYP2A6 probe drug (i.e., positive control) and letrozole as a high-impact object drug. Results will be used to inform future research on the potential use of cinnamon as a smoking cessation agent, as well as the clinical impact on pharmacotherapeutic regimens involving letrozole in cancer patients.
Detailed description
Cinnamon is used worldwide as both an additive and a botanical dietary supplement, the latter of which ranked within the 30 top-selling herbal supplements in 2020. Cinnamon is added to a variety of products, ranging from foods (e.g., breakfast cereals, baked goods) to fragrances and essential oils, to improve taste or smell. As a dietary supplement, cinnamon is commonly used to lower blood sugar and reduce inflammation. Cinnamon contains the abundant component, cinnamaldehyde (CA), a phenylpropanoid that emanates the flavor and scent of cinnamon. Research by Harrelson and colleagues has shown CA to inhibit the drug metabolizing enzyme cytochrome P450 (CYP) 2A6 in a time-dependent manner. That is, CYP2A6 metabolizes CA to a reactive intermediate that destroys the enzyme. Such substrates are also referred to as "suicide substrates". This type of enzyme inhibition is similar to that of grapefruit juice, which contains furanocoumarins that are time-dependent inhibitors of CYP3A in the intestine, leading to numerous potential adverse interactions with drugs metabolized by CYP3A. Unlike competitive inhibitors, time-dependent inhibitors inactivate the enzyme permanently, requiring de novo synthesis of the enzyme. As such, drug interactions with time-dependent inhibitors can last for several days. Relative to CYP3A, the list of clinically relevant CYP2A6 substrates is very short. However, two critical substrates include nicotine and the anticancer agent letrozole. Using an in vitro-to-in vivo extrapolation approach, CA was predicted to increase the area under the plasma concentration vs. time curve (AUC) of both substrates by 4- to 5-fold exceeding the FDA recommended cutoff (1.25) These compelling observations prompted this clinical study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cinnamon | Experimental | Dietary Supplement: Cinnamon (2 g)Arm 1 will consist of administration of a single dose of cinnamon (2 g) with water by mouth to 6 subjects (3 males, 3 females). 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. |
| Nicotine | Experimental | Drug: Nicotine gum (2.5 mg)Arm 2 will consist of administration of a single dose of nicotine gum (2 mg) to 16 subjects. 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. |
| Letrozole | Experimental | Drug: Letrozole (2.5 mg)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. |
| Cinnamon + Nicotine | Experimental | Dietary Supplement: Cinnamon (2 g), Drug: Nicotine gum (2.5 mg)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. |
| Cinnamon + Letrozole | Experimental | Dietary Supplement: Cinnamon (2 g), Drug: Letrozole (2.5 mg)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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females, aged from 18-64 years and healthy
- Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of either study drug or cinnamon constituents
- Willing to abstain from consuming dietary/herbal supplements and citrus juices for several weeks
- 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
- Willing to abstain from consuming any alcoholic beverages for one day prior to any study day, during the 14-hour inpatient days, and for the outpatient visit(s) following the 14-hour visit
Key exclusion criteria (11 listed)
- Under the age of 18 or 65+ years
- Any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
- History of anemia or any other significant hematologic disorder
- History of drug or alcohol addiction or major psychiatric illness
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinnamon (2 g)oral capsules, 2 g | Dietary supplement | Cinnamon, Cinnamon + Letrozole, Cinnamon + Nicotine |
| Nicotine gum (2.5 mg)Also: Nicorettegum, 2.5 mg | Drug | Cinnamon + Nicotine, Nicotine |
| Letrozole (2.5 mg)Also: Femaratablet, 2.5 mg | Drug | Cinnamon + Letrozole, Letrozole |
Primary outcome
Nicotine AUC
Time frame: 0-12h
Nicotine Area Under the Curve alone and in the presence of cinnamon
5 secondary outcomes
Letrozole AUC
Time frame: 0-240h
Letrozole Cmax
Time frame: 0-240h
Nicotine Half Life
Time frame: 0-12h
Nicotine Cmax
Time frame: 0-12h
Letrozole Half Life
Time frame: 0-240h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSmith T, Majid F, Eckl V, and Reynolds CM (2021) Herbal Supplement Sales in US Increase by Record-Breaking 17.3% in 2020. HerbalGram 131:52-65.
- Background: PubMed 22972104Leach MJ, Kumar S. Cinnamon for diabetes mellitus. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007170. doi: 10.1002/14651858.CD007170.pub2.
- Background: PubMed 26851241Chan J, Oshiro T, Thomas S, Higa A, Black S, Todorovic A, Elbarbry F, Harrelson JP. Inactivation of CYP2A6 by the Dietary Phenylpropanoid trans-Cinnamic Aldehyde (Cinnamaldehyde) and Estimation of Interactions with Nicotine and Letrozole. Drug Metab Dispos. 2016 Apr;44(4):534-43. doi: 10.1124/dmd.115.067942. Epub 2016 Feb 5.
- Background: PubMed 32788161Espiritu MJ, Chen J, Yadav J, Larkin M, Pelletier RD, Chan JM, Gc JB, Natesan S, Harrelson JP. Mechanisms of Herb-Drug Interactions Involving Cinnamon and CYP2A6: Focus on Time-Dependent Inhibition by Cinnamaldehyde and 2-Methoxycinnamaldehyde. Drug Metab Dispos. 2020 Oct;48(10):1028-1043. doi: 10.1124/dmd.120.000087. Epub 2020 Aug 12.
- BackgroundFDA (2020) Drug Interactions: Relevant Regulatory Guidance and Policy Documents
- Background: PubMed 29735755Paine MF, Shen DD, McCune JS. Recommended Approaches for Pharmacokinetic Natural Product-Drug Interaction Research: a NaPDI Center Commentary. Drug Metab Dispos. 2018 Jul;46(7):1041-1045. doi: 10.1124/dmd.117.079962. Epub 2018 May 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cinnamon (2 g), Nicotine gum (2.5 mg) and Letrozole (2.5 mg) in people with Interaction Drug Food, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine AUC (time frame: 0-12h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05157672, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.