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

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ClinicalTrials.gov Identifier: NCT02723617
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
David Baer, USDA Beltsville Human Nutrition Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: MED 0.5 Other: MED 2.5 Other: MED 5.5 Other: AAD 2.5 Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 16, 2018

Arm Intervention/treatment
MED 0.5 Other: MED 0.5
Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.

MED 2.5 Other: MED 2.5
Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef.

MED 5.5 Other: MED 5.5
Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef.

AAD 2.5 Other: AAD 2.5
Participants will be fed an average American diet providing 2.5 oz. per day of lean beef.




Primary Outcome Measures :
  1. Lipid/lipoprotein profile will be measured in 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) ]
    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).


Secondary Outcome Measures :
  1. Pulse Wave will be measured using Sphygmocor EXCEL [ 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.

  2. Markers of vascular health will be measured in 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) ]
    Adhesion molecules and endothelin-1 will be measured in the blood.

  3. Systemic inflammation will be measured in 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.

  4. Fecal microbiota will be analyzed [ 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.

  5. Measures of oxidative stress will be measured in urine [ 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.

  6. Blood glucose, serum insulin, and insulin c-peptide 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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723617


Locations
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United States, Maryland
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Penn State University

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Responsible Party: David Baer, Supervisory Research Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02723617     History of Changes
Other Study ID Numbers: HS54
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No