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

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

The objective of this study is to evaluate the effects of different quantities of lean beef (0.5, 2.5, 5.5 oz/day) on lipids, lipoproteins, and vascular health endpoints in the context of a modified Mediterranean dietary pattern that is representative of foods typically consumed in the United States.

Key facts

Study ID

NCT02723617

Run by

USDA Beltsville Human Nutrition Research Center

People needed

66

Starts

2016-04-25

Expected to finish

2018-05-16

Last updated by the study team

2019-05-01

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index between 20 and 40 kg/m2
• Non-smoker
• Fasting glucose ≤ 126 mg/dl

You may not qualify if…

• 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

Where it is running

• USDA-ARS, Beltsville Human Nutrition Research Center — Beltsville, Maryland, United States
• Penn State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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