Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Sponsor

University of Guelph (Other)

Overall Status

Completed

CT.gov ID

NCT01326442

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Hypertension Hyperlipidemia Obesity	Other: low glycemic diet Dietary Supplement: vitamin D omega-3	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diet only low glycemic index diet, calorie restricted with exercise 3 times per week.	Other: low glycemic diet a low glycemic diet, calorie restricted with exercise sessions 3 times per week
Active Comparator: supplemented 2000 IU vitamin D3 plus 1.8 g EPA + DHA	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.

Arm

Intervention/Treatment

Experimental: diet only

low glycemic index diet, calorie restricted with exercise 3 times per week.

Other: low glycemic diet

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

Active Comparator: supplemented

2000 IU vitamin D3 plus 1.8 g EPA + DHA

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.

Outcome Measures

Primary Outcome Measures

body weight [up to 16 weeks]
body weight will be measured to nearest 0.5 kg weekly

Secondary Outcome Measures

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.