Conditions: Metabolic Syndrome
Keywords: Blood Pressure Glucose levels HDL levels Triglyceride levels Waist Circumference
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 39
Healthy volunteers: no

Brief summary:
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.

Detailed description:
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.

Arms:
arm 1: Melatonin 8mg one hour before bedtime for 10 weeks arm 2: Placebo administered 1 hour before bedtime for 10 weeks

Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg dose of Melatonin intervention 2: Placebo

Protocol document: