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

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

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Article number124
JournalDiabetology and Metabolic Syndrome
Volume6
Issue number1
DOIs
StatePublished - Nov 18 2014

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Melatonin
Randomized Controlled Trials
Placebos
Blood Pressure
Fasting
Waist Circumference
Glucose
HDL Cholesterol
Triglycerides
Phase II Clinical Trials
Therapeutics

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Goyal, A., Terry, P., Superak, H. M., Nell-Dybdahl, C. L., Chowdhury, R., Phillips, L. S., & Kutner, M. H. (2014). Melatonin supplementation to treat the metabolic syndrome: A randomized controlled trial. Diabetology and Metabolic Syndrome, 6(1), [124]. https://doi.org/10.1186/1758-5996-6-124

Melatonin supplementation to treat the metabolic syndrome : A randomized controlled trial. / Goyal, Abhinav; Terry, Paul; Superak, Hillary M.; Nell-Dybdahl, Christine L.; Chowdhury, Ritam; Phillips, Lawrence S.; Kutner, Michael H.

In: Diabetology and Metabolic Syndrome, Vol. 6, No. 1, 124, 18.11.2014.

Research output: Contribution to journalArticle

Goyal, Abhinav ; Terry, Paul ; Superak, Hillary M. ; Nell-Dybdahl, Christine L. ; Chowdhury, Ritam ; Phillips, Lawrence S. ; Kutner, Michael H. / Melatonin supplementation to treat the metabolic syndrome : A randomized controlled trial. In: Diabetology and Metabolic Syndrome. 2014 ; Vol. 6, No. 1.
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abstract = "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.",
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AU - Kutner, Michael H.

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AB - 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.

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