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NCT Number: NCT04831398

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Health and Exercise Science

Norman, Oklahoma, 73019, United States

About this study

After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the University of Oklahoma Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once consented and enrolled, participants will be familiarized with experimental protocols. On separate days (visits 2 and 3), participants will complete placebo (PLA) and melatonin (MEL) in a randomly ordered, single-blind, counter-balanced design. PLA or MEL treatment will precede testing by 30min to maximize absorption into the circulation (Bartoli, 2013).

All experiments (PLA/MEL) will begin with the subject lying supine for 5 min of quiet rest where baseline measurements are taken, followed by activation of the lower body negative pressure (LBNP) device causing suction at -20 mmHg. Following LBNP participants will be given 10 minutes of rest to recover all variables to pre-LBNP values. After which participants will be given a hand grip dynamometer to complete 7 minutes of exercise at an intensity of 20% MVC at a 1s contraction to 2s relaxation cycle paced by a metronome. During the final 2 minutes of the 7 minutes of exercise the LBNP device will be activated again to -20mmHg such that the participant will be completing LBNP during rhythmic grip exercise. After the completion of exercise, the subject will remain supine for 10min. Then the a Total Labile Signal (TLS) procedure will be conducted. Where the experimental limb is occluded using a blood pressure cuff for 5min. The cuff is then rapidly deflated. The lowest oxyhemoglobin measured during the occlusion is recorded. After the TLS procedure, the subject will be de-instrumented and will leave the laboratory.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

melatonin

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Muscle Tissue Oxygenation

    Time frame: 7 minutes of rest and 7 minutes of exercise

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

  2. Mean Arterial Pressure

    Time frame: 7 minutes of rest and 7 minutes of exercise

    average pressure within the arteries

Secondary outcomes

  1. Cerebral Oxygenation

    Time frame: 7 minutes of rest and 7 minutes of exercise

    Concentrations of Total, Oxy, and deoxyhemoglobin of the Prefrontal Cortex of the brain

  2. Heart Rate

    Time frame: 7 minutes of rest and 7 minutes of exercise

    number of heart beats per minute

  3. Respiratory Rate

    Time frame: 7 minutes of rest and 7 minutes of exercise

    number of breaths per minute

  4. Cardiac Output

    Time frame: 7 minutes of rest and 7 minutes of exercise

    volume of blood pumped by the heart per minute

  5. Stroke Volume

    Time frame: 7 minutes of rest and 7 minutes of exercise

    volume of blood pumped by the heart per heart beat

  6. Total peripheral resistance

    Time frame: 7 minutes of rest and 7 minutes of exercise

    amount of force affecting resistance to blood flow throughout the circulatory system

  7. Heart Rate Variability

    Time frame: 7 minutes of rest and 7 minutes of exercise

    measure of the variation in time between each heart beat

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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