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The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation

NCT ID: NCT04831398

Last Updated: 2024-12-06

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-31

Brief Summary

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the purpose of this experiment is to determine if acute melatonin supplementation alters central and peripheral cardiovascular responses to a cold pressor test at rest and during dynamic exercise.

Detailed Description

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After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the University of Oklahoma Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once consented and enrolled, participants will be familiarized with experimental protocols. On separate days (visits 2 and 3), participants will complete placebo (PLA) and melatonin (MEL) in a randomly ordered, single-blind, counter-balanced design. PLA or MEL treatment will precede testing by 30min to maximize absorption into the circulation (Bartoli, 2013).

All experiments (PLA/MEL) will begin with the subject lying supine for 5 min of quiet rest where baseline measurements are taken, followed by activation of the lower body negative pressure (LBNP) device causing suction at -20 mmHg. Following LBNP participants will be given 10 minutes of rest to recover all variables to pre-LBNP values. After which participants will be given a hand grip dynamometer to complete 7 minutes of exercise at an intensity of 20% MVC at a 1s contraction to 2s relaxation cycle paced by a metronome. During the final 2 minutes of the 7 minutes of exercise the LBNP device will be activated again to -20mmHg such that the participant will be completing LBNP during rhythmic grip exercise. After the completion of exercise, the subject will remain supine for 10min. Then the a Total Labile Signal (TLS) procedure will be conducted. Where the experimental limb is occluded using a blood pressure cuff for 5min. The cuff is then rapidly deflated. The lowest oxyhemoglobin measured during the occlusion is recorded. After the TLS procedure, the subject will be de-instrumented and will leave the laboratory.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a single-blind crossover design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning whether they are receiving placebo/melatonin. Outcome assessors and statisticians may not be blinded to experimental allocation. Our placebo should satisfy two conditions of an ideal placebo: a) it should be indistinguishable from the experimental supplement to blinded participants, and b) it should be physiologically inert. In this study, 1 microliter McCormicks Pure Mint Extract will be mixed with 29 ml of filtered water and given to participants as a sublingual spray. This mixture will be non-caloric and will mimic the taste and sensation of the commercially available melatonin spray that will be used in the study (Onnit Labs Inc., Mint Flavor).

Study Groups

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Placebo

Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

10 sprays of diluted mint extract. This mimics the sensation and taste of the melatonin spray

Melatonin

5mg commercially available melatonin (MEL) spray will be given sublingually.

Group Type EXPERIMENTAL

melatonin

Intervention Type DIETARY_SUPPLEMENT

A 5mg dose of melatonin spay will be delivered sublingually.

Interventions

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melatonin

A 5mg dose of melatonin spay will be delivered sublingually.

Intervention Type DIETARY_SUPPLEMENT

Placebo

10 sprays of diluted mint extract. This mimics the sensation and taste of the melatonin spray

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women
* Women must be premenopausal with a regular menstrual cycle (26-30 days)

Exclusion Criteria

* History of autonomic dysfunction
* Cardiovascular diseases
* Diabetes
* Tobacco/nicotine use
* Systolic Pressure \>= 130 mmHg
* Diastolic Pressure \>= 85 mmHg
* Regular melatonin use \>= 1 use/week
* Allergy to melatonin
* Cardiometabolic medication use (e.g. anti-hypertensives, insulin-sensitizing, statins)
* Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone)
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy M Kellawan

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Department of Health and Exercise Science

Norman, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeremy M Kellawan, PhD

Role: CONTACT

Phone: 405 325 9028

Email: [email protected]

Yair Pincu

Role: CONTACT

Email: [email protected]

Facility Contacts

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Michael Bemben, PhD

Role: primary

Jeremy M Kellawan, PhD

Role: backup

Other Identifiers

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13084

Identifier Type: -

Identifier Source: org_study_id