Effects of melatonin on heart responses during exercise and cold exposure
The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation
PHASE4 · University of Oklahoma · NCT04831398
This study is testing if taking melatonin can change how the heart responds during exercise and when exposed to cold in people who participate.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Norman, Oklahoma) |
| Trial ID | NCT04831398 on ClinicalTrials.gov |
What this trial studies
This experiment aims to investigate how acute melatonin supplementation influences cardiovascular responses during sympathetic activation, specifically through a cold pressor test and dynamic exercise. Participants will undergo three visits, including a screening and two experimental sessions where they will receive either melatonin or a placebo in a randomized, single-blind design. Measurements will be taken at rest and during exercise to assess changes in cardiovascular function. The study is conducted at the University of Oklahoma's Human Circulation Research Laboratory.
Who should consider this trial
Good fit: Ideal candidates are healthy premenopausal men and women with regular menstrual cycles.
Not a fit: Patients with cardiovascular diseases, diabetes, or those using tobacco/nicotine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how melatonin affects cardiovascular health during stress conditions.
How similar studies have performed: While the effects of melatonin on sleep and circadian rhythms are well-documented, this specific approach to cardiovascular responses during sympathetic activation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Norman, Oklahoma
- Department of Health and Exercise Science — Norman, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Jeremy M Kellawan — University of Oklahoma
- Study coordinator: Jeremy M Kellawan, PhD
- Email: kellawan@ou.edu
- Phone: 405 325 9028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy