Meat And Dietary Pattern Study

HS68-Meat And Pattern Study

The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: High Healthy Eating Index Diet with Minimally Processed Meat; Other: High Healthy Eating Index Diet with Further Processed Meat; Other: Typical Healthy Eating Index Diet with Minimally Processed Meat; Other: Typical Healthy Eating Index Diet with Further Processed Meat

Detailed Description

Association studies have suggested that dietary meat intake may have negative impacts on health. However, these association studies have done a poor job separating meat intake from overall dietary pattern, as well as isolating effects of processed meat from minimally processed meat. Meat is a good source of several essential nutrients, including high quality protein, iron, and vitamin B12. This dietary intervention is designed to investigate the effects of minimally processed meat and further proceeded meat, as part of two different dietary patterns (the typical American dietary pattern and Dietary Guidelines dietary pattern) on outcomes related to chronic diseases.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS, Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female

Exclusion Criteria:

• Younger than 25 years old and older than 80 years old at the beginning of the intervention.
• Body mass index less than 18 or greater than 40 kg/m2.
• Blood pressure greater than 160/100 mm Hg or use of medication to treat hypertension for less than 6 months.
• Use of medications that will affect the study outcomes, including cholesterol lowering medications.
• Pregnant women, lactating women, women who plan to become pregnant during the study, or women who have given birth during the previous 12 months.
• Fasting blood glucose over 125 mg/dL or type 2 diabetes requiring medication.
• Body weight change of 10% in the past 3 months.
• History of bariatric or other gastrointestinal surgery that would affect digestion.
• History or presence of diabetes, kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
• Smokers, vapers, or other tobacco users (within 6 months prior to the start of the study).
• Use of an antibiotic within 1 month of the start of the study or during the study.
• Plans to have a colonoscopy during the study.
• Allergy to any food included in the study menus.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Healthy Eating Index Diet with Minimally Processed Meat; Participants will consume a diet with a high Healthy Eating Index along with meat that is minimally processed.	Other: High Healthy Eating Index Diet with Minimally Processed Meat; Participants will consume a diet with a high Healthy Eating Index along with meat that is minimally processed.
Experimental: High Healthy Eating Index Diet with Further Processed Meat; Participants will consume a diet with a high Healthy Eating Index along with meat that is further processed.	Other: High Healthy Eating Index Diet with Further Processed Meat; Participants will consume a diet with a high Healthy Eating Index along with meat that is further processed.
Experimental: Typical Healthy Eating Index Diet with Minimally Processed Meat; Participants will consume a diet with a typical Healthy Eating Index along with meat that is minimally processed.	Other: Typical Healthy Eating Index Diet with Minimally Processed Meat; Participants will consume a diet with a typical Healthy Eating Index along with meat that is minimally processed.
Experimental: Typical Healthy Eating Index Diet with Further Processed Meat; Participants will consume a diet with a typical Healthy Eating Index along with meat that is further processed.	Other: Typical Healthy Eating Index Diet with Further Processed Meat; Participants will consume a diet with a typical Healthy Eating Index along with meat that is further processed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Betaine Concentration	Betaine, which help make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 1
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 2
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 35
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 36
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 70
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 71
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 105
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 106
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 140
Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 141
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 1
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 2
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 35
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 36
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 70
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 71
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 105
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 106
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 140
Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 141

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 1
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 2
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 35
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 36
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 70
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 71
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 105
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 106
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 140
Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 141
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 1
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 2
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 35
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 36
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 70
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 71
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 105
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 106
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 140
Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 141
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 1
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 2
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 35
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 36
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 70
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 71
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 105
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 106
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 140
Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 141
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 1
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 2
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 35
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 36
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 70
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 71
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 105
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 106
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 140
Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 141
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 1
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 4
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 5
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 9
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 10
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 14
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 15
Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 19
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 1
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 4
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 5
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 9
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 10
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 14
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 15
Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 19
24-Hour Dietary Recall	Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).	5 to 7 days before Day 1
24-Hour Dietary Recall	Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).	3 to 5 days before Day 1
24-Hour Dietary Recall	Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).	1 to 3 days before Day 1
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 1
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 2
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 35
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 36
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 70
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 71
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 105
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 106
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 140
IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 141
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 1
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 2
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 35
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 36
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 70
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 71
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 105
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 106
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 140
C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 141
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 1
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 2
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 35
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 36
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 70
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 71
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 105
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 106
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 140
Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 141

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center
• Collaborators: National Cattlemen's Beef Association, a contractor to the Beef Checkoff
• Investigators: Principal Investigator: David J. Baer, PhD, USDA Beltsville Human Nutrition Research Center; Principal Investigator: Janet A. Novotny, PhD, USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HS68 - Meat And Pattern Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No