Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.

Abhinav Goyal,Hillary M Superak,Paul D Terry,Lawrence S Phillips,Michael H Kutner,Christine L Nell-Dybdahl,Ritam Chowdhury

doi:10.1186/1758-5996-6-124

Abstract

BackgroundSupplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking.MethodsWe conducted a double-blind, placebo-controlled, crossover, Phase II randomized pilot clinical trial to estimate the effects of melatonin supplementation on MetS components and the overall prevalence of MetS. We randomized 39 subjects with MetS to receive 8.0 mg oral melatonin or matching placebo nightly for 10 weeks. After a 6-week washout, subjects received the other treatment for 10 more weeks. We measured waist circumference, triglycerides, HDL cholesterol, fasting glucose, and blood pressure (BP) in each subject at the beginning and end of both 10-week treatment periods. The primary outcome was the mean 10-week change in each MetS component, and a secondary outcome was the proportion of subjects free from MetS, after melatonin versus placebo.ResultsThe mean 10-week change for most MetS components favored melatonin over placebo (except fasting glucose): waist circumference -0.9 vs. +1.0 cm (p = 0.15); triglycerides -66.3 vs. -4.2 mg/dL (p = 0.17); HDL cholesterol -0.2 vs. -1.1 mg/dL (p = 0.59); fasting glucose +0.3 vs. -3.1 mg/dL (p = 0.29); systolic BP -2.7 vs. +4.7 mmHg (p = 0.013); and diastolic BP -1.1 vs. +1.1 mmHg (p = 0.24). Freedom from MetS tended to be more common following melatonin versus placebo treatment (after the first 10 weeks, 35.3% vs. 15.0%, p = 0.25; after the second 10 weeks, 45.0% vs. 23.5%, p = 0.30). Melatonin was well-tolerated.ConclusionsMelatonin supplementation modestly improved most individual MetS components compared with placebo, and tended to increase the proportion of subjects free from MetS after treatment.Trial registrationNCT01038921, clinicaltrials.gov

Highlights

Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking
We conducted a pilot randomized, double-blind, crossover, placebo-controlled, Phase II clinical trial of melatonin supplementation in 39 women and men with MetS to determine whether melatonin is efficacious in ameliorating the individual MetS components, and in increasing the proportion of subjects free from MetS after treatment
Entry criteria Eligible subjects met three or more of the following five MetS criteria established by the National Heart, Lung, and Blood Institute and the American Heart Association [17]: elevated fasting glucose (≥100 mg/dL), elevated blood pressure (>130 mmHg systolic blood pressure [Systolic blood pressure (SBP)] or >85 mmHg diastolic diastolic blood pressure [Diastolic blood pressure (DBP)]), elevated triglycerides (≥150 mg/dL), reduced HDL cholesterol (

Summary

Introduction

Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking. The metabolic syndrome (MetS) is a cluster of metabolic risk factors with increasing worldwide prevalence [1]. The metabolic syndrome has been strongly associated with the risk of adverse cardiovascular events, new-onset diabetes mellitus, and all-cause mortality [2]. There is great interest in identifying interventions that can reduce the risk of adverse outcomes in persons with MetS. Randomized, placebocontrolled trials in humans are lacking. We conducted a pilot randomized, double-blind, crossover, placebo-controlled, Phase II clinical trial of melatonin supplementation in 39 women and men with MetS to determine whether melatonin is efficacious in ameliorating the individual MetS components (plasma glucose, blood pressure, triglycerides, waist circumference, and HDL-cholesterol), and in increasing the proportion of subjects free from MetS after treatment

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