Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03178396

Enrollment

Registered

2017-06-06

Start date

2015-12-07

Completion date

2016-08-09

Last updated

2017-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Prehypertension

Brief summary

The investigators will be studying the effect of melatonin on blood pressure, insulin resistance, and platelets, along with possible reasons for how melatonin cases these effects.

Detailed description

The investigators will be studying the effect of melatonin on blood pressure and insulin resistance, and possible reasons for how melatonin works on blood pressure and IR. Along with blood testing to measure adipokines, insulin resistance (IR), and platelet function (how well your blood clots), 24-hour ambulatory blood pressure monitoring (ABPM) will be used to measure blood pressure, since ABPM is the gold standard (best method) for accurate assessment of blood pressure status and associated cardiovascular risk. Vascular (blood vessel) function, IR, adipokine levels and sleep quality will also be measured. All study endpoints will be measured at baseline and following 6 weeks of daily melatonin 9 mg dosing.

Interventions

DIETARY_SUPPLEMENTmelatonin

controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Normotensive (SBP \<120) or prehypertensive (SBP = 120-139 mm Hg) * Age: Young/middle-aged (ages 18-45) and (2) 10 elderly subjects ages 65 and older

Exclusion criteria

* Patients with a diagnosis of * clinical hypertension and/or diabetes mellitus * pregnancy * coronary or cerebrovascular disease * collagen vascular disease, * organ failure (heart, kidney, liver). * Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins, * Patients who have taken melatonin previously in the past year.

Design outcomes

Primary

Measure	Time frame	Description
Ambulatory Systolic Blood pressure change	Baseline to 6 weeks	Change in 24 hour average Systolic blood pressure at 6 weeks
Office Systolic Blood pressure change	Baseline to 6 weeks	Change in Systolic blood pressure measured in the office at 6 weeks
Office Diastolic Blood pressure change	Baseline to 6 weeks	Change in Diastolic blood pressure measured in the office at 6 weeks
QUICKI: Quantitative insulin sensitivity check index change	Baseline to 6 weeks	Insulin sensitivity measure change at 6 weeks
Ambulatory Diastolic Blood pressure change	Baseline to 6 weeks	Change in 24 hour average Diastolic blood pressure at 6 weeks
HOMA: Homeostasis Model Assessment change	Baseline to 6 weeks	Insulin sensitivity measure change at 6 weeks

Secondary

Measure	Time frame	Description
Arachidonic acid stimulated aggregation change	Baseline to 6 weeks	Platelet activity measure change at 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026