Meat And Dietary Pattern Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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HS68-Meat And Pattern Study

Conditions
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Healthy Volunteers

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will be assigned to one or 24 possible treatment sequences.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |