RecruitingNot ApplicableNCT06826755

Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial


Sponsor

Mayo Clinic

Enrollment

70 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether melatonin — a natural hormone that regulates sleep — affects cardiovascular disease risk factors (like blood pressure and inflammation) in migrants, who may face unique stressors and health challenges related to displacement. **You may be eligible if...** - You are an adult who has migrated to the study country - You have cardiovascular risk factors such as high blood pressure, high cholesterol, or obesity - You are willing to take a melatonin supplement daily for the study period - You are not currently taking melatonin **You may NOT be eligible if...** - You have severe heart disease or have had a recent heart attack or stroke - You are taking medications that interact with melatonin (such as blood thinners or sedatives) - You are pregnant or breastfeeding - You have a sleep disorder being actively treated - You have autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTTerry Naturally® melatonin 5mg SR

Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.

DIETARY_SUPPLEMENTPlacebo

Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06826755


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