Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome

Study Overview
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Brief Summary
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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: Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will show similar or greater reductions in CVD risk, respectively when compared to a modified-DASH diet. A healthful weight-loss diet, including lean beef as the primary source of protein in a high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more than a BOLD + ex and DASH + ex intervention. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet more effective than the BOLD diet in maintaining the CVD benefits attained during phases 1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the modified DASH diet.

Official Title
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BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors: Effects on Metabolic Syndrome (BOLD-X)

Conditions
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Metabolic Syndrome, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: BOLD Diet
* Dietary Supplement: BOLD-X Diet
* Dietary Supplement: Modified DASH Diet


Participation Criteria
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Eligibility Criteria
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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)* BP medication accepted if BP stable and less than 160/100mm Hg Exclusion Criteria: A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication) Lactation, pregnancy, or desire to become pregnant during the study Intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods) High alcohol consumption (≥ 14 drinks/week) Participation in regular physical activity (> 1 formal session/week) Lipid or glucose lowering medication

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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: Modified-DASH Diet<br> | Dietary Supplement: Modified DASH Diet<br>* 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<br>* Other names: DASH diet;|
| Experimental: BOLD diet<br> | Dietary Supplement: BOLD Diet<br>* Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)<br>* Other names: Low fat, Step II diet;|
| Experimental: BOLD-X<br> | Dietary Supplement: BOLD-X Diet<br>* 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<br>* Other names: Low fat, moderate protein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular endothelial function measured by endo-PAT |  | 2 weeks | 
| Lipids and lipoproteins |  | 2 weeks | 
| Inflammatory markers |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Lean Beef, CVD