HS68-Meat And Pattern Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Betaine Concentration
Study Overview
Brief Summary
The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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/m
- •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.
Arms & Interventions
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.
Intervention: High Healthy Eating Index Diet with Minimally Processed Meat (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.
Intervention: High Healthy Eating Index Diet with Further Processed Meat (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.
Intervention: Typical Healthy Eating Index Diet with Minimally Processed Meat (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.
Intervention: Typical Healthy Eating Index Diet with Further Processed Meat (Other)
Outcomes
Primary Outcomes
Betaine Concentration
Time Frame: Day 141
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.
TMA (trimethylamine) Concentration
Time Frame: Day 141
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.
Blood Pressure
Time Frame: Day 141
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 141
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
LDL Cholesterol Concentration
Time Frame: Day 141
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.
HDL Cholesterol Concentration
Time Frame: Day 141
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.
Apolipoprotein Concentration
Time Frame: Day 141
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.
Carnitine Concentration
Time Frame: Day 141
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.
Choline Concentration
Time Frame: Day 141
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.
Triglyceride Concentration
Time Frame: Day 141
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 141
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 141
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.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 141
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 35
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
HDL Cholesterol Concentration
Time Frame: Day 140
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.
Triglyceride Concentration
Time Frame: Day 1
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 2
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Carnitine Concentration
Time Frame: Day 1
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.
Carnitine Concentration
Time Frame: Day 2
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.
Carnitine Concentration
Time Frame: Day 35
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.
Carnitine Concentration
Time Frame: Day 36
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.
Carnitine Concentration
Time Frame: Day 70
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.
Carnitine Concentration
Time Frame: Day 71
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.
Carnitine Concentration
Time Frame: Day 105
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.
Carnitine Concentration
Time Frame: Day 106
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.
Carnitine Concentration
Time Frame: Day 140
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.
Choline Concentration
Time Frame: Day 1
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.
Choline Concentration
Time Frame: Day 2
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.
Choline Concentration
Time Frame: Day 35
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.
Choline Concentration
Time Frame: Day 36
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.
Choline Concentration
Time Frame: Day 70
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.
Choline Concentration
Time Frame: Day 71
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.
Choline Concentration
Time Frame: Day 105
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.
Choline Concentration
Time Frame: Day 106
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.
Choline Concentration
Time Frame: Day 140
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.
Betaine Concentration
Time Frame: Day 1
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.
Betaine Concentration
Time Frame: Day 2
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.
Betaine Concentration
Time Frame: Day 35
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.
Betaine Concentration
Time Frame: Day 36
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.
Betaine Concentration
Time Frame: Day 70
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.
Betaine Concentration
Time Frame: Day 71
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.
Betaine Concentration
Time Frame: Day 105
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.
Betaine Concentration
Time Frame: Day 106
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.
Betaine Concentration
Time Frame: Day 140
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.
TMA (trimethylamine) Concentration
Time Frame: Day 1
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.
TMA (trimethylamine) Concentration
Time Frame: Day 2
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.
TMA (trimethylamine) Concentration
Time Frame: Day 35
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.
TMA (trimethylamine) Concentration
Time Frame: Day 36
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.
TMA (trimethylamine) Concentration
Time Frame: Day 70
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.
TMA (trimethylamine) Concentration
Time Frame: Day 71
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.
TMA (trimethylamine) Concentration
Time Frame: Day 105
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.
TMA (trimethylamine) Concentration
Time Frame: Day 106
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.
TMA (trimethylamine) Concentration
Time Frame: Day 140
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 1
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 2
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 35
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 36
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 70
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 71
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 105
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 106
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.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 140
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.
Total Cholesterol Concentration
Time Frame: Day 1
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 2
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 35
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 36
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 70
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 71
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 105
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 106
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 140
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
LDL Cholesterol Concentration
Time Frame: Day 1
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.
LDL Cholesterol Concentration
Time Frame: Day 2
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.
LDL Cholesterol Concentration
Time Frame: Day 35
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.
LDL Cholesterol Concentration
Time Frame: Day 36
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.
LDL Cholesterol Concentration
Time Frame: Day 70
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.
LDL Cholesterol Concentration
Time Frame: Day 71
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.
LDL Cholesterol Concentration
Time Frame: Day 105
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.
LDL Cholesterol Concentration
Time Frame: Day 106
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.
LDL Cholesterol Concentration
Time Frame: Day 140
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.
HDL Cholesterol Concentration
Time Frame: Day 1
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.
HDL Cholesterol Concentration
Time Frame: Day 2
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.
HDL Cholesterol Concentration
Time Frame: Day 35
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.
HDL Cholesterol Concentration
Time Frame: Day 36
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.
HDL Cholesterol Concentration
Time Frame: Day 70
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.
HDL Cholesterol Concentration
Time Frame: Day 71
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.
HDL Cholesterol Concentration
Time Frame: Day 105
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.
HDL Cholesterol Concentration
Time Frame: Day 106
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.
Triglyceride Concentration
Time Frame: Day 36
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 70
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 71
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 105
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 106
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 140
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Apolipoprotein Concentration
Time Frame: Day 1
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.
Apolipoprotein Concentration
Time Frame: Day 2
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.
Apolipoprotein Concentration
Time Frame: Day 35
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.
Apolipoprotein Concentration
Time Frame: Day 36
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.
Apolipoprotein Concentration
Time Frame: Day 70
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.
Apolipoprotein Concentration
Time Frame: Day 71
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.
Apolipoprotein Concentration
Time Frame: Day 105
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.
Apolipoprotein Concentration
Time Frame: Day 106
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.
Apolipoprotein Concentration
Time Frame: Day 140
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.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 1
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 2
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 35
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 36
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 70
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 71
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 105
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 106
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 140
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 1
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 2
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 35
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 36
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 70
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 71
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 105
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 106
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 140
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
Blood Pressure
Time Frame: Day 1
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 2
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 35
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 36
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 70
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 71
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 105
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 106
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Blood Pressure
Time Frame: Day 140
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Secondary Outcomes
- Hunger and Satiety(Week 19)
- Gut microbiota(Day 141)
- Glucose Concentration(Day 141)
- IL6 Concentration(Day 141)
- Diet Satisfaction(Week 19)
- C-Reactive Protein (CRP) Concentration(Day 141)
- Bile acid Concentration(Day 141)
- Serum Amyloid A Concentration(Day 141)
- Insulin Concentration(Day 141)
- 24-Hour Dietary Recall(1 to 3 days before Day 1)
- Glucose Concentration(Day 2)
- Gut microbiota(Day 1)
- Gut microbiota(Day 2)
- Gut microbiota(Day 35)
- Gut microbiota(Day 36)
- Gut microbiota(Day 70)
- Gut microbiota(Day 71)
- Gut microbiota(Day 105)
- Gut microbiota(Day 106)
- Gut microbiota(Day 140)
- Bile acid Concentration(Day 1)
- Bile acid Concentration(Day 2)
- Bile acid Concentration(Day 35)
- Bile acid Concentration(Day 36)
- Bile acid Concentration(Day 70)
- Bile acid Concentration(Day 71)
- Bile acid Concentration(Day 105)
- Bile acid Concentration(Day 106)
- Bile acid Concentration(Day 140)
- Glucose Concentration(Day 1)
- Glucose Concentration(Day 35)
- Glucose Concentration(Day 36)
- Glucose Concentration(Day 70)
- Glucose Concentration(Day 71)
- Glucose Concentration(Day 105)
- Glucose Concentration(Day 106)
- Glucose Concentration(Day 140)
- Insulin Concentration(Day 1)
- Insulin Concentration(Day 2)
- Insulin Concentration(Day 35)
- Insulin Concentration(Day 36)
- Insulin Concentration(Day 70)
- Insulin Concentration(Day 71)
- Insulin Concentration(Day 105)
- Insulin Concentration(Day 106)
- Insulin Concentration(Day 140)
- Diet Satisfaction(Week 1)
- IL6 Concentration(Day 1)
- Diet Satisfaction(Week 4)
- Diet Satisfaction(Week 5)
- Diet Satisfaction(Week 9)
- Diet Satisfaction(Week 10)
- Diet Satisfaction(Week 14)
- Diet Satisfaction(Week 15)
- Hunger and Satiety(Week 1)
- Hunger and Satiety(Week 4)
- Hunger and Satiety(Week 5)
- Hunger and Satiety(Week 9)
- Hunger and Satiety(Week 10)
- Hunger and Satiety(Week 14)
- Hunger and Satiety(Week 15)
- 24-Hour Dietary Recall(5 to 7 days before Day 1)
- 24-Hour Dietary Recall(3 to 5 days before Day 1)
- IL6 Concentration(Day 2)
- IL6 Concentration(Day 35)
- IL6 Concentration(Day 36)
- IL6 Concentration(Day 70)
- IL6 Concentration(Day 71)
- IL6 Concentration(Day 105)
- IL6 Concentration(Day 106)
- IL6 Concentration(Day 140)
- C-Reactive Protein (CRP) Concentration(Day 1)
- C-Reactive Protein (CRP) Concentration(Day 2)
- C-Reactive Protein (CRP) Concentration(Day 35)
- C-Reactive Protein (CRP) Concentration(Day 36)
- C-Reactive Protein (CRP) Concentration(Day 70)
- C-Reactive Protein (CRP) Concentration(Day 71)
- C-Reactive Protein (CRP) Concentration(Day 105)
- C-Reactive Protein (CRP) Concentration(Day 106)
- C-Reactive Protein (CRP) Concentration(Day 140)
- Serum Amyloid A Concentration(Day 1)
- Serum Amyloid A Concentration(Day 2)
- Serum Amyloid A Concentration(Day 35)
- Serum Amyloid A Concentration(Day 36)
- Serum Amyloid A Concentration(Day 70)
- Serum Amyloid A Concentration(Day 71)
- Serum Amyloid A Concentration(Day 105)
- Serum Amyloid A Concentration(Day 106)
- Serum Amyloid A Concentration(Day 140)
Investigators
David Baer
Supervisory Research Physiologist
USDA Beltsville Human Nutrition Research Center