The Dose-Response Effects of Lean Beef in a Mediterranean-Style Dietary Pattern on Cardiovascular Disease Risk Factors

The DASH (Dietary Approaches to Stop Hypertension) dietary pattern, the USDA Food Pattern,
and the American Heart Association (AHA) Diet are all recommended for the reduction of LDL-C
and blood pressure, two major risk factors for cardiovascular disease (CVD). The recommended
food-based dietary patterns emphasize consumption of vegetables, fruits and whole grains;
include low-fat dairy products, poultry, fish, legumes, non-tropical vegetable oils and nuts;
and limit intake of sweets, sugar-sweetened beverages and red meats. The Mediterranean
dietary pattern has gained widespread popularity because of an impressive evidence base
showing health benefits in the prevention of many chronic diseases including CVD. The
Mediterranean Diet Pyramid recommends that red meat be consumed less than 2 servings per
week, with an emphasis on lean cuts. However, as the BOLD (Beef in an Optimal Lean Diet)
study has demonstrated, lean beef can be included in a heart healthy dietary pattern that
achieves both low density lipoprotein and blood pressure-lowering effects. The BOLD study
utilized beef consumption levels of 4 or 5.4 ounces of lean beef daily, which is
significantly higher than the American average of app. 3 ounces per day. This study will
evaluate three levels of beef in the context of a Mediterranean diet, compared to an Average
American diet.

Inclusion Criteria:

- Body Mass Index between 20 and 40 kg/m2

- Non-smoker

- Fasting glucose ≤ 126 mg/dl

Exclusion Criteria:

- Low HDL-C (<15th percentile of US population)

- Use of cholesterol lowering medications

- Elevated blood pressure (systolic blood pressure > 160 mm Hg and diastolic blood
pressure > 100 mm Hg) or use of medication to treat hypertension for less than 6
months

- Elevated triglycerides ( > 350 mg/dL)

- Active cardiovascular disease (such as a heart attack or procedure within the past six
months or participation in a cardiac rehabilitation program within the last six
months, stroke, or history/treatment for transient ischemic attacks in the past six
months, or documented history of pulmonary embolus in the past six months)

- Presence of kidney disease, liver disease, gout, untreated or unstable hyper- or
hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other
metabolic diseases, or malabsorption syndromes

- Women who have given birth during the previous 12 months

- Pregnant women or women who plan to become pregnant or become pregnant during the
study

- Lactating women

- Weight loss of ≥ 10% of body weight within 6 months prior to enrolling in the study

- Smokers or use of any tobacco products in past 6 months

- Known (self-reported) allergy or adverse reaction to study foods

- History of eating disorders or other dietary patterns which are not consistent with
the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)

- Unable or unwilling to give informed consent or communicate with study staff

- Self-report of alcohol or substance abuse within the past 12 months and/or current
acute treatment or rehabilitation program for these problems (long-term participation
in Alcoholics Anonymous is not an exclusion)

- Other medical, psychiatric, or behavioral factors that in the judgment of the
Principal Investigator may interfere with study participation or the ability to follow
the intervention protocol