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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler. |
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| Melatonin | Other | Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terry Naturally® melatonin 5mg SR | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nocturnal Systolic Blood Pressure (SBP) | Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping. | Measured at baseline and at the end of the 12-week intervention |
| Change in Nocturnal Diastolic Blood Pressure (DBP) | Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping. | Measured at baseline and at the end of the 12-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxidative Stress Markers | Assessed using Blood and urine samples analyzed by Mayo Clinic Laboratories. | Measured at baseline and at the end of the 12-week intervention. |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Perimenopause Study Team | Contact | 507-255-8897 | PerimenopauseStdy@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Naima Covassin, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Dietary Supplement | 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. |
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