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| Name | Class |
|---|---|
| National Cattlemen's Beef Association, a contractor to the Beef Checkoff | INDUSTRY |
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The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain their weight loss, as is currently recommended in clinical practice. Importantly, the investigators will compare a diet high in lean beef (5 oz/day) which is compositionally similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors, including MetSyn. In addition, the investigators also will evaluate a moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study was conducted to assess dietary compliance in a sub-sample of the population at 12-months; participants were not informed of this end-point and additional consent was obtained.
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified-DASH Diet | Experimental |
| |
| BOLD diet | Experimental |
| |
| BOLD-X | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOLD Diet | Dietary Supplement | Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP | 2 weeks | |
| Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP | 7 weeks | |
| Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP | 13 weeks | |
| Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular endothelial function measured by endo-PAT | 2 weeks | |
| Lipids and lipoproteins | 2 weeks | |
| Inflammatory markers |
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Inclusion Criteria:
(BMI 27-42 kg/m2)
Three or more of the following risk factors (defined as having MetSyn):
abdominal obesity [waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women],
elevated blood glucose [> 110mg/dl (6.1 mmol/L)]
elevated TG [>150 mg/dl (1.7 mmol/L)]
low HDL-C [<40 mg/dl (1.03 mmol/L) in men and <50 mg/dL (1.29 mmol/l) in women]
hypertension (Systolic Blood Pressure > 130 mmHg or Diastolic Blood Pressure > 85 mmHg)*
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny M Kris-Etherton, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26354540 | Derived | Hill AM, Harris Jackson KA, Roussell MA, West SG, Kris-Etherton PM. Type and amount of dietary protein in the treatment of metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2015 Oct;102(4):757-70. doi: 10.3945/ajcn.114.104026. Epub 2015 Sep 9. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| BOLD-X Diet | Dietary Supplement | Low-fat, moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet. Also high in fruits and vegetables |
|
|
| Modified DASH Diet | Dietary Supplement | Low-fat, high fruit and vegetable diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors and metabolic syndrome |
|
|
| 2 weeks |
| Vascular endothelial function measured by endo-PAT | 7 weeks |
| Vascular endothelial function measured by endo-PAT | 13 weeks |
| Vascular endothelial function measured by endo-PAT | 24 weeks |
| Lipids and lipoproteins | 7 weeks |
| Lipids and lipoproteins | 13 weeks |
| Lipids and lipoproteins | 24 weeks |
| Inflammatory markers | 7 weeks |
| Inflammatory markers | 13 weeks |
| Inflammatory markers | 24 weeks |
| Dietary analysis | macro-and micronutrients | 52 weeks |
| Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP | 52 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |