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

Hypertension Perimenopause

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

Inclusion Criteria5

Age 40-55 years old
Female individuals with intact uterus and at least one ovary
Hypertension
o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
On stable medical regimen (≥ 2 months) if taking other medications

Exclusion Criteria14

Prescription sleeping medications or melatonin supplementation
Pregnant or lactating
Use of tobacco, nicotine or vaping products
Night shift work
On prescription aspirin
Severe lactose intolerance
History of substance use disorder
History of suicidal ideation
History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (\<11.6 g/dL) within the past 12 months
Active cancer
Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale \[ESS\])81
Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
Inability to provide written consent and/or to speak and read English
Any other medical, geographic, or social factor making study participation impractical

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