Healthy VolunteersNCT02723617
The Dose-Response Effects of Lean Beef in a Mediterranean-Style Dietary Pattern on Cardiovascular Disease Risk Factors
A study testing MED 0.5, MED 2.5 and MED 5.5 in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MED 0.5, MED 2.5 and MED 5.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2016to 16 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index between 20 and 40 kg/m2
- Non-smoker
- Fasting glucose ≤ 126 mg/dl
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
Penn State University
University Park, Pennsylvania, 16802
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- MED 0.5, MED 2.5, MED 5.5, AAD 2.5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED 0.5Other
Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.
MED 2.5Other
Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef.
MED 5.5Other
Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef.
AAD 2.5Other
Participants will be fed an average American diet providing 2.5 oz. per day of lean beef.
| Study group | Role | What they receive |
|---|---|---|
| MED 0.5 | Other | Not described Receives: Other: MED 0.5 |
| MED 2.5 | Other | Not described Receives: Other: MED 2.5 |
| MED 5.5 | Other | Not described Receives: Other: MED 5.5 |
| AAD 2.5 | Other | Not described Receives: Other: AAD 2.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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)
Secondary outcomes (6)
Pulse Wave will be measured using Sphygmocor EXCEL
Pulse wave analysis and pulse wave velocity will be conducted.
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)
Markers of vascular health will be measured in blood
Adhesion molecules and endothelin-1 will be measured in the blood.
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)
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.
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)
Fecal microbiota will be analyzed
Feces will be analyzed for bacterial typing.
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)
Measures of oxidative stress will be measured in urine
Urinary 8-iso-PGF-2α and urinary 15-keto-dihydro- PGF-2α will be measured.
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.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start25 Apr 2016
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, David Baer, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723617
- Sponsor's protocol ID
- HS54
- Status last verified
- Apr 2019
- First submitted
- 23 Mar 2016
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40970516Fleming 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.
PubMed 40201153Fleming 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.
PubMed 33826691
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose-Response Effects of Lean Beef in a Mediterranean-Style Dietary Pattern on Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT02723617
- Acronym / sponsor ID
- HS54
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Collaborators
- Penn State University
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MED 0.5 | Other | Other: MED 0.5 |
| MED 2.5 | Other | Other: MED 2.5 |
| MED 5.5 | Other | Other: MED 5.5 |
| AAD 2.5 | Other | Other: AAD 2.5 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index between 20 and 40 kg/m2
- Non-smoker
- Fasting glucose ≤ 126 mg/dl
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MED 0.5Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef. | Other | MED 0.5 |
| MED 2.5Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef. | Other | MED 2.5 |
| MED 5.5Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef. | Other | MED 5.5 |
| AAD 2.5Participants will be fed an average American diet providing 2.5 oz. per day of lean beef. | Other | AAD 2.5 |
Primary outcome
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).
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 40970516DiMattia 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.
- Derived from this study: PubMed 40201153Fleming 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.
- Derived from this study: PubMed 33826691Fleming 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MED 0.5, MED 2.5 and MED 5.5 in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723617, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.