The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation

NCT04831398 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 13084
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

the purpose of this experiment is to determine if acute melatonin supplementation alters central and peripheral cardiovascular responses to a cold pressor test at rest and during dynamic exercise.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Muscle Tissue Oxygenation

  Concentrations of Total, Oxy, and deoxyhemoglobin of Flexor Digitorum Profundus muscle of the forearm

  7 minutes of rest and 7 minutes of exercise

• Mean Arterial Pressure

  average pressure within the arteries

  7 minutes of rest and 7 minutes of exercise

Secondary Outcomes (7)

• Cerebral Oxygenation

  7 minutes of rest and 7 minutes of exercise

• Heart Rate

  7 minutes of rest and 7 minutes of exercise

• Respiratory Rate

  7 minutes of rest and 7 minutes of exercise

• Cardiac Output

  7 minutes of rest and 7 minutes of exercise

• Stroke Volume

  7 minutes of rest and 7 minutes of exercise

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract.

Other: Placebo

Melatonin

EXPERIMENTAL

5mg commercially available melatonin (MEL) spray will be given sublingually.

Dietary Supplement: melatonin

Interventions

melatonin DIETARY_SUPPLEMENT

A 5mg dose of melatonin spay will be delivered sublingually.

Melatonin

Placebo OTHER

10 sprays of diluted mint extract. This mimics the sensation and taste of the melatonin spray

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• Women must be premenopausal with a regular menstrual cycle (26-30 days)

You may not qualify if:

• History of autonomic dysfunction
• Cardiovascular diseases
• Diabetes
• Tobacco/nicotine use
• Systolic Pressure \>= 130 mmHg
• Diastolic Pressure \>= 85 mmHg
• Regular melatonin use \>= 1 use/week
• Allergy to melatonin
• Cardiometabolic medication use (e.g. anti-hypertensives, insulin-sensitizing, statins)
• Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone)
• Pregnancy

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Department of Health and Exercise Science

Norman, Oklahoma, 73019, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jeremy M Kellawan

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning whether they are receiving placebo/melatonin. Outcome assessors and statisticians may not be blinded to experimental allocation. Our placebo should satisfy two conditions of an ideal placebo: a) it should be indistinguishable from the experimental supplement to blinded participants, and b) it should be physiologically inert. In this study, 1 microliter McCormicks Pure Mint Extract will be mixed with 29 ml of filtered water and given to participants as a sublingual spray. This mixture will be non-caloric and will mimic the taste and sensation of the commercially available melatonin spray that will be used in the study (Onnit Labs Inc., Mint Flavor).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-blind crossover design.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: January 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)