NCT05589389

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

October 11, 2022

Last Update Submit

January 10, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (130)

  • 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 Outcomes (89)

  • Gut microbiota

    Day 1

  • Gut microbiota

    Day 2

  • Gut microbiota

    Day 35

  • Gut microbiota

    Day 36

  • Gut microbiota

    Day 70

  • +84 more secondary outcomes

Study Arms (4)

High Healthy Eating Index Diet with Minimally Processed Meat

EXPERIMENTAL

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

High Healthy Eating Index Diet with Further Processed Meat

EXPERIMENTAL

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

Typical Healthy Eating Index Diet with Minimally Processed Meat

EXPERIMENTAL

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

Typical Healthy Eating Index Diet with Further Processed Meat

EXPERIMENTAL

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

Interventions

High Healthy Eating Index Diet with Minimally Processed MeatOTHER

Participants will consume a diet with a high Healthy Eating Index along with meat that is minimally processed.

High Healthy Eating Index Diet with Minimally Processed Meat
High Healthy Eating Index Diet with Further Processed MeatOTHER

Participants will consume a diet with a high Healthy Eating Index along with meat that is further processed.

High Healthy Eating Index Diet with Further Processed Meat
Typical Healthy Eating Index Diet with Minimally Processed MeatOTHER

Participants will consume a diet with a typical Healthy Eating Index along with meat that is minimally processed.

Typical Healthy Eating Index Diet with Minimally Processed Meat
Typical Healthy Eating Index Diet with Further Processed MeatOTHER

Participants will consume a diet with a typical Healthy Eating Index along with meat that is further processed.

Typical Healthy Eating Index Diet with Further Processed Meat

Eligibility Criteria

Age25 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Officials

  • David J. Baer, PhD

    USDA Beltsville Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

  • Janet A. Novotny, PhD

    USDA Beltsville Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Subjects will be assigned to one or 24 possible treatment sequences.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisory Research Physiologist

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 21, 2022

Study Start

October 26, 2022

Primary Completion

June 30, 2023

Study Completion

July 30, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)