NCT01326442

Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Guelph · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease. Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and blood collected at weeks 0 and 16.

Conditions

• Type 2 Diabetes Mellitus
• Hypertension
• Hyperlipidemia
• Obesity

Interventions

Type	Name	Description
OTHER	low glycemic diet	a low glycemic diet, calorie restricted with exercise sessions 3 times per week
DIETARY_SUPPLEMENT	vitamin D omega-3	2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-03-30
• Last updated: 2013-06-13

Locations

1 site across 1 country: Canada