Cinnamon for Drug-Food Interaction

Overseen By Deena L Hadi, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington State University

Must not be taking: Prescription drugs, Herbal supplements

Disqualifiers: Chronic illness, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

16 Participants Needed

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.

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.

What data supports the effectiveness of the treatment involving cinnamon, letrozole, and nicotine replacement therapy?

Research shows that nicotine replacement therapy, such as nicotine gum, can help people quit smoking by reducing withdrawal symptoms and increasing quit rates. This suggests that nicotine replacement therapy is effective in supporting smoking cessation. ^{1 2 3 4 5}

Is nicotine polacrilex safe for human use?

Nicotine polacrilex, used in lozenges and gum for smoking cessation, is generally considered safe when used as directed. 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 carbon monoxide and tar. ^{1 2 6 7 8}

What makes the drug Letrozole with Nicotine gum and Cinnamon unique for drug-food interactions?

This treatment is unique because it explores the interaction between Letrozole, a cancer medication, and food components like Cinnamon and Nicotine gum, which may affect drug absorption and metabolism, potentially altering its effectiveness or safety. ^{9 10 11 12 13}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cinnamon Administration

Participants receive a single dose of cinnamon (2 g) with water by mouth

0-48 hours

1 visit (in-person)

Nicotine Administration

Participants receive a single dose of nicotine gum (2 mg)

0-12 hours

1 visit (in-person)

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

6 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Nicotine Experimental Treatment 1 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: Letrozole Experimental Treatment 1 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 + Nicotine Experimental Treatment 2 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 + Letrozole Experimental Treatment 2 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: Cinnamon Experimental Treatment 1 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 United States, European Union, Canada for the following indications:

Approved in United States as Femara for:

• Breast cancer in postmenopausal women
• Increasing the chance of ovulation in women with polycystic ovary syndrome

Approved in European Union as Letrozole for:

• Early breast cancer in postmenopausal women
• Advanced breast cancer in postmenopausal women

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

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Office of Dietary Supplements (ODS)

Collaborator

Trials

55

Recruited

54,500+

Findings from Research

In a study of 158 smokers, transdermal nicotine patches significantly improved smoking cessation rates, with 39% of participants using 24-hour patches and 35% using patches during wakeful hours achieving abstinence, compared to only 13.5% in the placebo group.

The nicotine patches also effectively reduced tobacco withdrawal symptoms during the initial weeks of quitting, demonstrating their safety and efficacy as an adjunct to low-intervention therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo]. Daughton, DM., Heatley, SA., Prendergast, JJ., et al.[2015]

In a study of 158 smokers, transdermal nicotine patches significantly improved smoking cessation rates, with 39% of participants using 24-hour patches and 35% using patches during wakeful hours achieving abstinence, compared to only 13.5% in the placebo group.

The nicotine patches also effectively reduced tobacco withdrawal symptoms during the initial weeks of quitting, demonstrating their safety and efficacy as an adjunct to low-intervention therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. Daughton, DM., Heatley, SA., Prendergast, JJ., et al.[2017]

Nicotine gum, which binds nicotine to a polacrilex, is an effective method for treating tobacco dependence by transferring nicotine dependence from cigarettes to a safer form, reducing the risk of relapse.

The effectiveness of nicotine gum can be influenced by factors such as the dose, dosing schedule, and how vigorously it is chewed, highlighting the importance of proper administration for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic effects of nicotine polacrilex. Nemeth-Coslett, R.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for tobacco dependence. [2017]

2. Italy pubmed.ncbi.nlm.nih.gov

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

A double-blind trial of a 16-hour transdermal nicotine patch in smoking cessation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Electronic cigarettes: The nicotyrine hypothesis. [2017]

6. France pubmed.ncbi.nlm.nih.gov

Physiologic effects of nicotine polacrilex. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a nicotine polacrilex lozenge. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A pharmacokinetic crossover study to compare the absorption characteristics of three transdermal nicotine patches. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[Drug-food interactions in internal medicine: What physicians should know?]. [2018]

10. Serbia pubmed.ncbi.nlm.nih.gov

Food and drugs. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of food on drug absorption. [2008]

12. Spain pubmed.ncbi.nlm.nih.gov

[Drug-food interactions]. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

An approach to evaluating drug-nutrient interactions. [2005]