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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diet only | Experimental | low glycemic index diet, calorie restricted with exercise 3 times per week. |
|
| supplemented | Active Comparator | 2000 IU vitamin D3 plus 1.8 g EPA + DHA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low glycemic diet | Other | a low glycemic diet, calorie restricted with exercise sessions 3 times per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight | body weight will be measured to nearest 0.5 kg weekly | up to 16 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly A Meckling, PhD | University of Guelph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guelph | Guelph | Ontario | N1G2W1 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D050177 | Overweight |
| D056128 | Obesity, Abdominal |
| D007333 | Insulin Resistance |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| vitamin D omega-3 | Dietary Supplement | 2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks. |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |