MED 0.5
OtherParticipants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.
NCT Number: NCT02723617
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.
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Notify Me30 year–65 year
All sexes
Interventional
Not applicable
USDA-ARS, Beltsville Human Nutrition Research Center, Beltsville, Maryland, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.
Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef.
Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef.
Participants will be fed an average American diet providing 2.5 oz. per day of lean beef.
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
The following will be measured in the blood on 2 consecutive days at baseline (start of trial) and the end of each 4-week diet period: lipids and lipoproteins, apolipoproteins, lipoprotein particle number/size, and proprotein convertase subtilisin/kexin type 9 (PCSK9).
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
Pulse wave analysis and pulse wave velocity will be conducted.
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
Adhesion molecules and endothelin-1 will be measured in the blood.
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
Markers of systemic inflammation will be measured, such as fibrinogen, IL-6, TNF-alpha, serum amyloid A, and CRP.
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
Feces will be analyzed for bacterial typing.
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
Urinary 8-iso-PGF-2α and urinary 15-keto-dihydro- PGF-2α will be measured.
Time frame: Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)
Blood glucose and serum insulin and insulin c-peptide will be measured.
USDA Beltsville Human Nutrition Research Center
Fed
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