Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations

NCT ID: NCT06382610

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-19
• Study Completion Date: 2024-07-31

Brief Summary

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.

Detailed Description

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount. Researchers will characterize the time course of the absorption and metabolism of lotion- and bubble bath-based melatonin compared to oral tablets in healthy 18-22 year olds.

The peak level, time to peak level and half-life of melatonin will be compared between the administration routes using a within-person (repeated measures) design and saliva sampling over 48 hours. Participants can choose specific days to participate within a one-month window, with a maximum of four sampling periods. All participants will collect control saliva samples (no melatonin treatment) one night at 10 PM and 4 AM. Participants will be asked to have two treatments 1) oral melatonin and 2) either lotion melatonin or bubble-bath melatonin. Participants can indicate if they have a preference for lotion vs. bubble bath or if they are willing to undergo both lotion and bubble bath treatments (adding a fourth sampling period). Order will be randomized.

For the treatments, saliva sampling times are as follows: Prior to melatonin administration (10 AM), then 15 min, 30 min, 45 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours (10 PM), 18 hours (4 AM), 24 hours, 36 hours, and 48 hours after administration. Samples will be frozen at the participant's home until returned to the researchers at a later date. Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Oral tablet

3 mg Tablets (Nature Made). Participants will need to fast for 2 hours prior to consumption and 2 hours after consumption.

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Melatonin will be administered in three different forms

Lotion

Dr. Teal's Sleep Lotion with Melatonin, Lavender, and Chamomile. 3 g lotion applied to one arm (without washing for at least 4 hours).

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Melatonin will be administered in three different forms

Bubble bath

Dr. Teal's Sleep Bath with Melatonin, Lavender, and Chamomile. 40L warm tap water maintained between 36.5 - 40 degrees C (98 - 104 degrees F) and 2 ml bubble bath. Participants will soak their feet and legs in the cooler for 15 minutes and then dry off (without rinsing or washing for at least 4 hours).

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Melatonin will be administered in three different forms

Interventions

Melatonin

Melatonin will be administered in three different forms

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• University of Redlands student

Exclusion Criteria

• Allergies or sensitivities to scented lotions or bath products
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Redlands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa E Olson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Redlands

Locations

University of Redlands

Redlands, California, United States

Countries

United States

Other Identifiers

2024-002

Identifier Type: -

Identifier Source: org_study_id