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The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-fat diet first then Low-fat diet | Experimental |
| |
| Low-fat diet first then Full-fat diet | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-fat diet | Other | The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol | Total Cholesterol will be measured by a blood sample and reported as mg/dL | Baseline, Week 3, Week 5, Week 8 |
| Change in HDL-C (High Density Lipoprotein Cholesterol) | High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL | Baseline, Week 3, Week 5, Week 8 |
| Change in LDL-C (Low Density Lipoprotein Cholesterol) | Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL | Baseline, Week 3, Week 5, Week 8 |
| Change in Triglycerides | Triglycerides will be measured by a blood sample and reported as mg/dL | Baseline, Week 3, Week 5, Week 8 |
| Change in Blood Glucose | Blood Glucose will be measured by a blood sample and reported as mg/dL | Baseline, Week 3, Week 5, Week 8 |
| Change in Hemoglobin A1c | Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin. | Baseline, Week 3, Week 5, Week 8 |
| Change in C-reactive protein | C-reactive protein will be measured by a blood sample and reported as mg/L |
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Inclusion Criteria: Presence of 3 of the following risk factors:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Bruhn | Contact | 507-266-2690 | bruhn.eric@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Smith, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low-fat diet | Other | The patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks. |
|
| Baseline, Week 3, Week 5, Week 8 |
| Change in Lipoprotein | Lipoprotein will be measured by a blood sample and reported as mg/dL | Baseline, Week 3, Week 5, Week 8 |
| Change in Macrovascular Function | Peripheral macrovascular function is the maximal percent change in brachial artery following cuff release and will be assessed via flow-mediated dilation and reported as a percentage | Baseline, Week 3, Week 5, Week 8 |
| Change in Microvascular Function | Quantification of the area under the curve of the brachial artery blood flow following cuff release | Baseline, Week 3, Week 5, Week 8 |
| D009750 |
| Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |