Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia, Obesity

Intervention / Treatment
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* Other: low glycemic diet
* Dietary Supplement: vitamin D omega-3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet only<br>low glycemic index diet, calorie restricted with exercise 3 times per week. | Other: low glycemic diet<br>* a low glycemic diet, calorie restricted with exercise sessions 3 times per week<br>|
| Active Comparator: supplemented<br>2000 IU vitamin D3 plus 1.8 g EPA + DHA | Other: low glycemic diet<br>* a low glycemic diet, calorie restricted with exercise sessions 3 times per week<br>Dietary Supplement: vitamin D omega-3<br>* 2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | body weight will be measured to nearest 0.5 kg weekly | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | systolic and diastolic blood pressure will be measured in duplicate, weekly | up to 16 weeks | 
| Blood lipids | blood lipids will be measured at baseline and after study completion. | up to 16 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, overweight, body composition, visceral obesity, insulin, glucose tolerance, cholesterol, hypertriglyceridemia