Clinical trial NCT05589389: Meat and Dietary Pattern Study
Official title: HS68-Meat and Pattern Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: National Cattlemen's Beef Association
First posted: 2022-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be assigned to one or 24 possible treatment sequences.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Carnitine Concentration
timeFrame: Day 1
measure: Carnitine Concentration
timeFrame: Day 2
measure: Carnitine Concentration
timeFrame: Day 35
measure: Carnitine Concentration
timeFrame: Day 36
measure: Carnitine Concentration
timeFrame: Day 70
measure: Carnitine Concentration
timeFrame: Day 71
measure: Carnitine Concentration
timeFrame: Day 105
measure: Carnitine Concentration
timeFrame: Day 106
measure: Carnitine Concentration
timeFrame: Day 140
measure: Carnitine Concentration
timeFrame: Day 141
measure: Choline Concentration
timeFrame: Day 1
measure: Choline Concentration
timeFrame: Day 2
measure: Choline Concentration
timeFrame: Day 35
measure: Choline Concentration
timeFrame: Day 36
measure: Choline Concentration
timeFrame: Day 70
measure: Choline Concentration
timeFrame: Day 71
measure: Choline Concentration
timeFrame: Day 105
measure: Choline Concentration
timeFrame: Day 106
measure: Choline Concentration
timeFrame: Day 140
measure: Choline Concentration
timeFrame: Day 141
measure: Betaine Concentration
timeFrame: Day 1
measure: Betaine Concentration
timeFrame: Day 2
measure: Betaine Concentration
timeFrame: Day 35
measure: Betaine Concentration
timeFrame: Day 36
measure: Betaine Concentration
timeFrame: Day 70
measure: Betaine Concentration
timeFrame: Day 71
measure: Betaine Concentration
timeFrame: Day 105
measure: Betaine Concentration
timeFrame: Day 106
measure: Betaine Concentration
timeFrame: Day 140
measure: Betaine Concentration
timeFrame: Day 141
measure: TMA (trimethylamine) Concentration
timeFrame: Day 1
measure: TMA (trimethylamine) Concentration
timeFrame: Day 2
measure: TMA (trimethylamine) Concentration
timeFrame: Day 35
measure: TMA (trimethylamine) Concentration
timeFrame: Day 36
measure: TMA (trimethylamine) Concentration
timeFrame: Day 70
measure: TMA (trimethylamine) Concentration
timeFrame: Day 71
measure: TMA (trimethylamine) Concentration
timeFrame: Day 105
measure: TMA (trimethylamine) Concentration
timeFrame: Day 106
measure: TMA (trimethylamine) Concentration
timeFrame: Day 140
measure: TMA (trimethylamine) Concentration
timeFrame: Day 141
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 1
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 2
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 35
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 36
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 70
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 71
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 105
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 106
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 140
measure: TMAO (trimethylamine N-oxide) Concentration
timeFrame: Day 141
measure: Total Cholesterol Concentration
timeFrame: Day 1
measure: Total Cholesterol Concentration
timeFrame: Day 2
measure: Total Cholesterol Concentration
timeFrame: Day 35
measure: Total Cholesterol Concentration
timeFrame: Day 36
measure: Total Cholesterol Concentration
timeFrame: Day 70
measure: Total Cholesterol Concentration
timeFrame: Day 71
measure: Total Cholesterol Concentration
timeFrame: Day 105
measure: Total Cholesterol Concentration
timeFrame: Day 106
measure: Total Cholesterol Concentration
timeFrame: Day 140
measure: Total Cholesterol Concentration
timeFrame: Day 141
measure: LDL Cholesterol Concentration
timeFrame: Day 1
measure: LDL Cholesterol Concentration
timeFrame: Day 2
measure: LDL Cholesterol Concentration
timeFrame: Day 35
measure: LDL Cholesterol Concentration
timeFrame: Day 36
measure: LDL Cholesterol Concentration
timeFrame: Day 70
measure: LDL Cholesterol Concentration
timeFrame: Day 71
measure: LDL Cholesterol Concentration
timeFrame: Day 105
measure: LDL Cholesterol Concentration
timeFrame: Day 106
measure: LDL Cholesterol Concentration
timeFrame: Day 140
measure: LDL Cholesterol Concentration
timeFrame: Day 141
measure: HDL Cholesterol Concentration
timeFrame: Day 1
measure: HDL Cholesterol Concentration
timeFrame: Day 2
measure: HDL Cholesterol Concentration
timeFrame: Day 35
measure: HDL Cholesterol Concentration
timeFrame: Day 36
measure: HDL Cholesterol Concentration
timeFrame: Day 70
measure: HDL Cholesterol Concentration
timeFrame: Day 71
measure: HDL Cholesterol Concentration
timeFrame: Day 105
measure: HDL Cholesterol Concentration
timeFrame: Day 106
measure: HDL Cholesterol Concentration
timeFrame: Day 140
measure: HDL Cholesterol Concentration
timeFrame: Day 141
measure: Triglyceride Concentration
timeFrame: Day 1
measure: Triglyceride Concentration
timeFrame: Day 2
measure: Triglyceride Concentration
timeFrame: Day 35
measure: Triglyceride Concentration
timeFrame: Day 36
measure: Triglyceride Concentration
timeFrame: Day 70
measure: Triglyceride Concentration
timeFrame: Day 71
measure: Triglyceride Concentration
timeFrame: Day 105
measure: Triglyceride Concentration
timeFrame: Day 106
measure: Triglyceride Concentration
timeFrame: Day 140
measure: Triglyceride Concentration
timeFrame: Day 141
measure: Apolipoprotein Concentration
timeFrame: Day 1
measure: Apolipoprotein Concentration
timeFrame: Day 2
measure: Apolipoprotein Concentration
timeFrame: Day 35
measure: Apolipoprotein Concentration
timeFrame: Day 36
measure: Apolipoprotein Concentration
timeFrame: Day 70
measure: Apolipoprotein Concentration
timeFrame: Day 71
measure: Apolipoprotein Concentration
timeFrame: Day 105
measure: Apolipoprotein Concentration
timeFrame: Day 106
measure: Apolipoprotein Concentration
timeFrame: Day 140
measure: Apolipoprotein Concentration
timeFrame: Day 141
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 1
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 2
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 35
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 36
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 70
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 71
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 105
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 106
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 140
measure: Lipoprotein(a) (Lp(a)) Concentration
timeFrame: Day 141
measure: Low Density Lipoprotein particle size
timeFrame: Day 1
measure: Low Density Lipoprotein particle size
timeFrame: Day 2
measure: Low Density Lipoprotein particle size
timeFrame: Day 35
measure: Low Density Lipoprotein particle size
timeFrame: Day 36
measure: Low Density Lipoprotein particle size
timeFrame: Day 70
measure: Low Density Lipoprotein particle size
timeFrame: Day 71
measure: Low Density Lipoprotein particle size
timeFrame: Day 105
measure: Low Density Lipoprotein particle size
timeFrame: Day 106
measure: Low Density Lipoprotein particle size
timeFrame: Day 140
measure: Low Density Lipoprotein particle size
timeFrame: Day 141
measure: Blood Pressure
timeFrame: Day 1
measure: Blood Pressure
timeFrame: Day 2
measure: Blood Pressure
timeFrame: Day 35
measure: Blood Pressure
timeFrame: Day 36
measure: Blood Pressure
timeFrame: Day 70
measure: Blood Pressure
timeFrame: Day 71
measure: Blood Pressure
timeFrame: Day 105
measure: Blood Pressure
timeFrame: Day 106
measure: Blood Pressure
timeFrame: Day 140
measure: Blood Pressure
timeFrame: Day 141
Secondary outcomes:
measure: Gut microbiota
timeFrame: Day 1
measure: Gut microbiota
timeFrame: Day 2
measure: Gut microbiota
timeFrame: Day 35
measure: Gut microbiota
timeFrame: Day 36
measure: Gut microbiota
timeFrame: Day 70
measure: Gut microbiota
timeFrame: Day 71
measure: Gut microbiota
timeFrame: Day 105
measure: Gut microbiota
timeFrame: Day 106
measure: Gut microbiota
timeFrame: Day 140
measure: Gut microbiota
timeFrame: Day 141
measure: Bile acid Concentration
timeFrame: Day 1
measure: Bile acid Concentration
timeFrame: Day 2
measure: Bile acid Concentration
timeFrame: Day 35
measure: Bile acid Concentration
timeFrame: Day 36
measure: Bile acid Concentration
timeFrame: Day 70
measure: Bile acid Concentration
timeFrame: Day 71
measure: Bile acid Concentration
timeFrame: Day 105
measure: Bile acid Concentration
timeFrame: Day 106
measure: Bile acid Concentration
timeFrame: Day 140
measure: Bile acid Concentration
timeFrame: Day 141
measure: Glucose Concentration
timeFrame: Day 1
measure: Glucose Concentration
timeFrame: Day 2
measure: Glucose Concentration
timeFrame: Day 35
measure: Glucose Concentration
timeFrame: Day 36
measure: Glucose Concentration
timeFrame: Day 70
measure: Glucose Concentration
timeFrame: Day 71
measure: Glucose Concentration
timeFrame: Day 105
measure: Glucose Concentration
timeFrame: Day 106
measure: Glucose Concentration
timeFrame: Day 140
measure: Glucose Concentration
timeFrame: Day 141
measure: Insulin Concentration
timeFrame: Day 1
measure: Insulin Concentration
timeFrame: Day 2
measure: Insulin Concentration
timeFrame: Day 35
measure: Insulin Concentration
timeFrame: Day 36
measure: Insulin Concentration
timeFrame: Day 70
measure: Insulin Concentration
timeFrame: Day 71
measure: Insulin Concentration
timeFrame: Day 105
measure: Insulin Concentration
timeFrame: Day 106
measure: Insulin Concentration
timeFrame: Day 140
measure: Insulin Concentration
timeFrame: Day 141
measure: Diet Satisfaction
timeFrame: Week 1
measure: Diet Satisfaction
timeFrame: Week 4
measure: Diet Satisfaction
timeFrame: Week 5
measure: Diet Satisfaction
timeFrame: Week 9
measure: Diet Satisfaction
timeFrame: Week 10
measure: Diet Satisfaction
timeFrame: Week 14
measure: Diet Satisfaction
timeFrame: Week 15
measure: Diet Satisfaction
timeFrame: Week 19
measure: Hunger and Satiety
timeFrame: Week 1
measure: Hunger and Satiety
timeFrame: Week 4
measure: Hunger and Satiety
timeFrame: Week 5
measure: Hunger and Satiety
timeFrame: Week 9
measure: Hunger and Satiety
timeFrame: Week 10
measure: Hunger and Satiety
timeFrame: Week 14
measure: Hunger and Satiety
timeFrame: Week 15
measure: Hunger and Satiety
timeFrame: Week 19
measure: 24-Hour Dietary Recall
timeFrame: 5 to 7 days before Day 1
measure: 24-Hour Dietary Recall
timeFrame: 3 to 5 days before Day 1
measure: 24-Hour Dietary Recall
timeFrame: 1 to 3 days before Day 1
measure: IL6 Concentration
timeFrame: Day 1
measure: IL6 Concentration
timeFrame: Day 2
measure: IL6 Concentration
timeFrame: Day 35
measure: IL6 Concentration
timeFrame: Day 36
measure: IL6 Concentration
timeFrame: Day 70
measure: IL6 Concentration
timeFrame: Day 71
measure: IL6 Concentration
timeFrame: Day 105
measure: IL6 Concentration
timeFrame: Day 106
measure: IL6 Concentration
timeFrame: Day 140
measure: IL6 Concentration
timeFrame: Day 141
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 1
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 2
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 35
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 36
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 70
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 71
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 105
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 106
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 140
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Day 141
measure: Serum Amyloid A Concentration
timeFrame: Day 1
measure: Serum Amyloid A Concentration
timeFrame: Day 2
measure: Serum Amyloid A Concentration
timeFrame: Day 35
measure: Serum Amyloid A Concentration
timeFrame: Day 36
measure: Serum Amyloid A Concentration
timeFrame: Day 70
measure: Serum Amyloid A Concentration
timeFrame: Day 71
measure: Serum Amyloid A Concentration
timeFrame: Day 105
measure: Serum Amyloid A Concentration
timeFrame: Day 106
measure: Serum Amyloid A Concentration
timeFrame: Day 140
measure: Serum Amyloid A Concentration
timeFrame: Day 141
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS, Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA Beltsville Human Nutrition Research Center
name: David J. Baer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA Beltsville Human Nutrition Research Center
name: Janet A. Novotny, PhD
role: PRINCIPAL_INVESTIGATOR
References: