Hypertension, Perimenopause
Conditions
Brief 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.
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nocturnal Systolic Blood Pressure (SBP) | Measured at baseline and at the end of the 12-week intervention | Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping. |
| Change in Nocturnal Diastolic Blood Pressure (DBP) | Measured at baseline and at the end of the 12-week intervention. | Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxidative Stress Markers | Measured at baseline and at the end of the 12-week intervention. | Assessed using Blood and urine samples analyzed by Mayo Clinic Laboratories. |
Countries
United States
Contacts
CONTACTPerimenopause Study Team
PRINCIPAL_INVESTIGATORNaima Covassin, Ph.D.
Mayo Clinic
Outcome results
None listed