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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-07

Study Completion Date

2016-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood

NCT06378567

Sleep Mood Stress

COMPLETED NA

Bioavailability and Bioactivity of Red Wine Melatonin in Humans

NCT02767102

Bioavailability

COMPLETED NA

Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults

NCT02675582

Cognitive Function and Mood

COMPLETED NA

Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

NCT02572219

Hypertension

COMPLETED PHASE3

Effect of a Specific Phenolic Compound on Blood Pressure

NCT02628353

Cardiovascular Risk Factors Blood Pressure

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prehypertension Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Young, intervention

patients ages 18-45, taking melatonin

Group Type EXPERIMENTAL

melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Young, control

patients ages 18-45, usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Older, intervention

patients ages 60 and older, taking melatonin

Group Type EXPERIMENTAL

melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Older, control

patients ages 60 and older, usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

melatonin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Life Extension Foundation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes