100 Participants Needed

Melatonin for Cardiovascular Response to Stress

YP
JM
Overseen ByJeremy M Kellawan, PhD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing if taking melatonin can change how the heart and blood vessels respond to cold and exercise in healthy people. Melatonin might help manage stress on the heart and blood vessels by calming the nervous system. Melatonin has been shown to influence the cardiovascular system by reducing blood pressure, altering nerve activity, and affecting blood vessel function.

Will I have to stop taking my current medications?

If you are taking cardiometabolic medications (like blood pressure or cholesterol meds) or sex hormone replacements, you will need to stop taking them to join this trial.

What data supports the effectiveness of the drug melatonin for cardiovascular response to stress?

Research shows that melatonin can help lower blood pressure at night in people with high blood pressure and may improve heart health by reducing stress on the heart. It also has antioxidant and anti-inflammatory properties, which can be beneficial for cardiovascular health.12345

Is melatonin generally safe for human use?

Melatonin is generally considered safe for human use, with most studies reporting minor and short-lived side effects like fatigue and mood changes. However, it can affect reproductive, cardiovascular, and metabolic systems, and its long-term safety, especially in children, is not well-studied. It's important to use it as directed and be cautious of interactions with other medications.678910

How does the drug melatonin differ from other treatments for cardiovascular stress?

Melatonin is unique because it helps regulate the body's internal clock, which can improve blood pressure control, especially at night, by synchronizing circadian rhythms. Unlike other treatments, it works by enhancing the function of the biological clock and has additional benefits like improving sleep quality.14111213

Research Team

JM

Jeremy M Kellawan

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for healthy men and women, specifically premenopausal women with regular menstrual cycles. It excludes those on cardiometabolic meds, with high blood pressure or diabetes, using sex hormone replacements or tobacco products, pregnant individuals, people with a history of autonomic dysfunction, cardiovascular diseases, allergies to melatonin or regular users of melatonin.

Inclusion Criteria

I am a healthy man or woman.
I am a premenopausal woman with a regular menstrual cycle.

Exclusion Criteria

You use tobacco or nicotine products.
I am using sex hormone replacement therapy.
You are allergic to melatonin.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment

Participants complete placebo and melatonin treatments in a single-blind, counter-balanced design

2 visits
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Melatonin
Trial OverviewThe study aims to see if taking melatonin once can change how the heart and blood vessels respond to stress from cold exposure at rest and during exercise. Participants will be randomly given either melatonin or a placebo (a dummy pill) to compare effects.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
5mg commercially available melatonin (MEL) spray will be given sublingually.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract.

Melatonin is already approved in European Union, United States for the following indications:

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Approved in European Union as Circadin for:
  • Insomnia in adults aged 55 and over
  • Sleep disorders in children with autism spectrum disorder
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Approved in European Union as Slenyto for:
  • Insomnia in children and adolescents aged 2-18 with autism spectrum disorder
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Approved in United States as Melatonin for:
  • Sleep disorders in children with autism spectrum disorder
  • Insomnia in adults

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Findings from Research

In a study involving 16 men with untreated essential hypertension, repeated nighttime intake of melatonin (2.5 mg daily for 3 weeks) significantly reduced nocturnal blood pressure by 6 mm Hg systolic and 4 mm Hg diastolic, without affecting heart rate.
The study suggests that enhancing circadian rhythm function through melatonin may offer a new treatment strategy for essential hypertension, as improvements in blood pressure were statistically unrelated to sleep quality enhancements.
Daily nighttime melatonin reduces blood pressure in male patients with essential hypertension.Scheer, FA., Van Montfrans, GA., van Someren, EJ., et al.[2016]
Young men with polymorbid cardiovascular pathology (PCVP) showed lower levels of nocturnal melatonin excretion, which correlated with more severe depressive and anxiety symptoms, indicating a potential link between melatonin levels and mental health in these patients.
Comprehensive treatment that included psychotherapy and psychophysiological sessions led to greater improvements in melatonin levels and overall health indicators compared to standard therapy alone, suggesting that a multi-faceted approach may be more effective for managing PCVP.
Melatonin: Manager of psychosomatic and metabolic disorders in polymorbid cardiovascular pathology.Partsernyak, AS., Polyakova, VO., Trufanov, AG., et al.[2022]
Timed melatonin administration may offer a new treatment approach for cardiac ischemia and hypertension that does not respond to traditional medications, suggesting its potential efficacy in managing these conditions.
The study builds on previous research linking melatonin to blood pressure regulation and circadian rhythms, indicating that timing of melatonin could be crucial for optimizing its therapeutic effects.
Melatonin, refractory hypertension, myocardial ischemia and other challenges in nightly blood pressure lowering.Zaslavskaya, RM., Lilitsa, GV., Dilmagambetova, GS., et al.[2019]

References

Daily nighttime melatonin reduces blood pressure in male patients with essential hypertension. [2016]
Melatonin: Manager of psychosomatic and metabolic disorders in polymorbid cardiovascular pathology. [2022]
Melatonin, refractory hypertension, myocardial ischemia and other challenges in nightly blood pressure lowering. [2019]
Melatonin and circadian biology in human cardiovascular disease. [2013]
Melatonin and Human Cardiovascular Disease. [2019]
Adverse events associated with oral administration of melatonin: A critical systematic review of clinical evidence. [2019]
Treatment of circadian rhythm disorders--melatonin. [2019]
Melatonin's Benefits and Risks as a Therapy for Sleep Disturbances in the Elderly: Current Insights. [2022]
Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin. [2021]
Potential safety issues in the use of the hormone melatonin in paediatrics. [2015]
Central melatonin receptors: implications for a mode of action. [2019]
The internal time-giver role of melatonin. A key for our health. [2022]
[Anti-hypertensive action of melatoninergic compounds]. [2014]