Design and rationale of a randomized controlled trial of melatonin supplementation in men and women with the metabolic syndrome

• Type of Material: Article
• Authors: Paul D. Terry, University of Tennessee; Abhinav Goyal, Emory University; Lawrence S Phillips, Emory University; Hillary M. Superak, Emory University; Michael Kutner, Emory University
• Language: English
• Date: 2013-03-06
• Publisher: Dovepress
• Publication Version: Final Published Version
• Copyright Statement: © 2013 The Author(s)
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): https://doi.org/10.2147/OAJCT.S39551
• Title of Journal or Parent Work: Open Access Journal of Clinical Trials
• Volume: 2013
• Issue: 5
• Start Page: 51
• End Page: 59
• Grant/Funding Information: The study was funded by the National Institutes of Health/National Center for Comple- mentary and Alternative Medicine R21 AT004220-01A2, and was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR000454.
• Keywords: diabetes; blood pressure; sleep; metabolic syndrome; melatonin
• Research Categories: Health Sciences, Public Health; Chemistry, Pharmaceutical

Abstract

Background: The metabolic syndrome is a constellation of interrelated metabolic risk factors that appear to increase the risk of atherosclerotic cardiovascular disease, type 2 diabetes mellitus, and possibly some cancers. Animal studies and observational clinical data in humans suggest that supplemental melatonin may ameliorate a number of components of the metabolic syndrome, including elevated glucose, elevated blood pressure, dyslipidemia, and obesity. The primary objective of this clinical trial was to determine the feasibility, efficacy, and safety of melatonin supplementation in men and women with the metabolic syndrome. Methods: Thirty-nine men and women of mixed race/ethnicity were enrolled into a randomized, double-blind, placebo-controlled clinical trial with two arms: placebo for 10 weeks followed by melatonin for 10 weeks, or vice versa, with an interval 6-week washout period, in a crossover trial design. Outcome measures include metabolic syndrome components (blood pressure, glucose, triglycerides, high-density lipoprotein cholesterol, waist circumference), oxidative stress, and inflammation biomarkers. These biomarkers, along with sleep duration and quality and pretreatment endogenous melatonin levels, were measured to explore possible underlying biologic mechanisms. Discussion: This trial will provide knowledge of the effects of melatonin in metabolic syndrome subjects, and lay the groundwork for future clinical trials of melatonin in metabolic syndrome subjects.