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Search / Trial NCT04831398

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

Launched by UNIVERSITY OF OKLAHOMA · Apr 1, 2021

Trial Information

Current as of May 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a supplement called melatonin affects the heart and blood vessels during stress, specifically when exposed to cold and during exercise. Researchers want to see if taking melatonin can change how the body responds to these situations. The trial is currently looking for healthy men and women between the ages of 65 and 74. Women who want to participate must be premenopausal and have regular menstrual cycles.

If you qualify and decide to join the study, you will be asked to perform some tests while resting and during exercise to see how your cardiovascular system reacts after taking melatonin. To be eligible, you should not have any history of heart or blood pressure issues, diabetes, or be a regular user of melatonin or certain medications. This trial is a chance to contribute to research that could help us understand more about the effects of melatonin on heart health.

Gender

ALL

Eligibility criteria

  • 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

About University Of Oklahoma

The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.

Locations

Norman, Oklahoma, United States

Patients applied

0 patients applied

Trial Officials

Jeremy M Kellawan

Principal Investigator

University of Oklahoma

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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