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Aromatase Inhibitor

Cinnamon (2 g) for Drug-Food Interaction

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-240 hours
Awards & highlights

Study Summary

This trial will study how taking a cinnamon supplement affects the way the body processes medications.

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.Check my eligibility
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.See study design
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
Select...
I am not taking any medications or supplements that affect how drugs or cinnamon work in my body.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nicotine area under the concentration vs. time curve (AUC) ratio (exposure/baseline)
Secondary outcome measures
Cinnamon constituent area under the concentration vs. time curve (AUC)
Cinnamon constituent half-life
Cinnamon constituent maximum concentration (Cmax)
+5 more

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.

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
827 Previous Clinical Trials
668,728 Total Patients Enrolled
Washington State UniversityLead Sponsor
99 Previous Clinical Trials
56,448 Total Patients Enrolled
Office of Dietary Supplements (ODS)NIH
52 Previous Clinical Trials
54,431 Total Patients Enrolled

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05157672 — Phase < 1
Drug-Food Interaction Research Study Groups: Letrozole, Cinnamon + Letrozole, Nicotine, Cinnamon, Cinnamon + Nicotine
Drug-Food Interaction Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT05157672 — Phase < 1
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157672 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other experimental studies been conducted involving Cinnamon (2 g)?

"Currently, there are 224 sanctioned clinical trials centered around Cinnamon (2 g). Out of these studies, 44 are within Phase 3 and the majority originate from Shanghai. Moreover, a total of 11171 sites worldwide administer research on this particular topic."

Answered by AI

Are participants in this trial of age 20 or older?

"According to the study's entry requirements, prospective participants must fall between 18 and 64 years of age. Additionally, there are 8 trials designed specifically for minors and 190 studies targeting seniors."

Answered by AI

Am I able to enroll in this medical trial?

"This research seeks 22 participants aged 18 to 64 who meet the following criteria: abstaining from prescribed and over-the-counter medications, supplements known to affect pharmacokinetics of study drug or cinnamon constituents, skipping dietary/herbal supplements and citrus juices for weeks prior, avoiding caffeine in evening before & morning of first day of a study arm, no alcohol intake 1 day pre & post 14 hours inpatient days; using an acceptable contraceptive method excluding oral contraceptives (abstinence, copper IUD etc.), having enough time for participation."

Answered by AI

What is the total enrolment for this investigation?

"Indeed, the information hosted on clinicaltrials.gov verifies that this trial is still recruiting members since it was first posted in December 2021 and last modified in September 2022. Altogether, 22 participants will be accepted at a single site."

Answered by AI

Is recruitment for participants in this research study still open?

"Affirmative. Clinicaltrials.gov corroborates that this trial is currently accepting participants; it was initially posted on December 14th 2021 and recently refreshed on September 1st 2022. 22 individuals must be sourced from a single medical facility for the study to continue as planned."

Answered by AI

What medical symptoms are typically addressed with a two-gram dose of Cinnamon?

"Cinnamon (2 g) is the most common treatment for breast-related issues, but it can be used to assist in managing nicotine withdrawal symptoms, anovulatory cycles and tamoxifen therapy."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Washington State University College of Pharmacy and Pharmaceutical Sciences
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~5 spots leftby Mar 2025