Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypertension; Hyperlipidemia; Obesity
• Interventions: Other: low glycemic diet; Dietary Supplement: vitamin D omega-3

• Registration Number: NCT01326442
• Lead Sponsor: University of Guelph

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Study Start: 2011-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diet only	low glycemic diet	low glycemic index diet, calorie restricted with exercise 3 times per week.
supplemented	low glycemic diet	2000 IU vitamin D3 plus 1.8 g EPA + DHA
supplemented	vitamin D omega-3	2000 IU vitamin D3 plus 1.8 g EPA + DHA

Primary Outcome Measures

Name	Time	Method
body weight	up to 16 weeks	body weight will be measured to nearest 0.5 kg weekly

Secondary Outcome Measures

Name	Time	Method
Blood pressure	up to 16 weeks	systolic and diastolic blood pressure will be measured in duplicate, weekly
Blood lipids	up to 16 weeks	blood lipids will be measured at baseline and after study completion.
Glucose homeostasis	up to 16 weeks	fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.

Trial Locations

Locations (1)

University of Guelph; 🇨🇦 Guelph, Ontario, Canada