Melatonin and the Metabolic Syndrome (MetSyn)
Melatonin is a hormone that regulates some body functions, including the sleep/wake cycle. Some people take melatonin supplements (over the counter) for promoting sleep. Some studies suggest that melatonin may help improve blood pressure, glucose levels, blood lipid levels, which are components of "the metabolic syndrome." This trial seeks to compare the effects of melatonin supplementation versus placebo on these factors in patients with metabolic syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial|
- Metabolic syndrome components [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Melatonin 8mg one hour before bedtime for 10 weeks
Placebo Comparator: Placebo
The primary purpose of this Phase II crossover design trial is to examine the safety and efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to improve at least one of the five components associated with the metabolic syndrome.