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| Name | Class |
|---|---|
| Penn State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MED 0.5 | Other |
| |
| MED 2.5 | Other |
| |
| MED 5.5 | Other |
| |
| AAD 2.5 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED 0.5 | Other | Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lipid/lipoprotein profile will be measured in blood | 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave will be measured using Sphygmocor EXCEL | Pulse wave analysis and pulse wave velocity will be conducted. | 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 vascular health will be measured in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA-ARS, Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States | ||
| Penn State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40970516 | Derived | DiMattia ZS, Zhao J, Hao F, Koshkin S, Bisanz JE, Patterson AD, Fleming JA, Kris-Etherton PM, Petersen KS. Effect of Varying Quantities of Lean Beef as Part of a Mediterranean-Style Dietary Pattern on Gut Microbiota and Plasma, Fecal, and Urinary Metabolites: A Randomized Crossover Controlled Feeding Trial. J Am Heart Assoc. 2025 Oct 7;14(19):e041063. doi: 10.1161/JAHA.125.041063. Epub 2025 Sep 19. | |
| 40201153 |
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| MED 2.5 | Other | Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef. |
|
| MED 5.5 | Other | Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef. |
|
| AAD 2.5 | Other | Participants will be fed an average American diet providing 2.5 oz. per day of lean beef. |
|
Adhesion molecules and endothelin-1 will be measured in the blood. |
| 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) |
| Systemic inflammation will be measured in blood | Markers of systemic inflammation will be measured, such as fibrinogen, IL-6, TNF-alpha, serum amyloid A, and CRP. | 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) |
| Fecal microbiota will be analyzed | Feces will be analyzed for bacterial typing. | 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) |
| Measures of oxidative stress will be measured in urine | Urinary 8-iso-PGF-2α and urinary 15-keto-dihydro- PGF-2α will be measured. | 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, serum insulin, and insulin c-peptide will be measured. | Blood glucose and serum insulin and insulin c-peptide will be measured. | 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) |
| University Park |
| Pennsylvania |
| 16802 |
| United States |
| Derived |
| Fleming JA, Petersen KS, Kris-Etherton PM, Baer DJ. A Mediterranean-Style Diet with Lean Beef Lowers Blood Pressure and Improves Vascular Function: Secondary Outcomes from a Randomized Crossover Trial. Curr Dev Nutr. 2025 Feb 22;9(4):104573. doi: 10.1016/j.cdnut.2025.104573. eCollection 2025 Apr. |
| 33826691 | Derived | Fleming JA, Kris-Etherton PM, Petersen KS, Baer DJ. Effect of varying quantities of lean beef as part of a Mediterranean-style dietary pattern on lipids and lipoproteins: a randomized crossover controlled feeding trial. Am J Clin Nutr. 2021 May 8;113(5):1126-1136. doi: 10.1093/ajcn/nqaa375. |