Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326442
• Other study ID #: 2011MeckVitD
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2011
• Last updated: June 12, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• must have Metabolic Syndrome as defined by International Diabetes Federation

• must be able to swallow tablets and capsules

• must be 18 years of age or older

• must be physically capable of moderate intensity exercise

Exclusion Criteria:

• pregnant or lactating

• vegetarian

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Metabolic Syndrome X
• Obesity
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight will be measured to nearest 0.5 kg weekly	up to 16 weeks	No
Secondary	Blood pressure	systolic and diastolic blood pressure will be measured in duplicate, weekly	up to 16 weeks	No
Secondary	Blood lipids	blood lipids will be measured at baseline and after study completion.	up to 16 weeks	No
Secondary	Glucose homeostasis	fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.	up to 16 weeks	No