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

Diabetology & Metabolic Syndrome

Michael H Kutner³  Lawrence S Phillips¹  Ritam Chowdhury⁵  Christine L Nell-Dybdahl²  Hillary M Superak³  Paul D Terry⁶  Abhinav Goyal⁴ 

[1] Department of Medicine, Division of Endocrinology, Emory University School of Medicine, Atlanta, GA, USA;Emory Center for Heart Disease Prevention, Emory Healthcare, Atlanta, GA, USA;Department of Biostatistics and Bioinformatics, Emory Rollins School of Public Health, Atlanta, GA, USA;Department of Epidemiology, Emory Rollins School of Public Health, Atlanta, GA, USA;James T. Laney School of Graduate Studies, Emory University, Atlanta, GA, USA;Departments of Surgery and Public Health, University of Tennessee, 1914 Andy Holt Ave., HPER 390, Knoxville, TN 37996, USA

关键词: Randomized controlled trial;    Metabolic syndrome;    Melatonin;   

Others  :  1138288
DOI  :  10.1186/1758-5996-6-124

 received in 2014-07-19, accepted in 2014-11-04,  发布年份 2014

【 摘 要 】

Background

Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking.

Methods

We 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.

Results

The 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.

Conclusions

Melatonin supplementation modestly improved most individual MetS components compared with placebo, and tended to increase the proportion of subjects free from MetS after treatment.

Trial registration

NCT01038921, clinicaltrials.gov

【 授权许可】

   
2014 Goyal et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

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