HS68-Meat And Pattern Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Betaine Concentration
Study Overview
Brief Summary
The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.
Detailed Description
Association studies have suggested that dietary meat intake may have negative impacts on health. However, these association studies have done a poor job separating meat intake from overall dietary pattern, as well as isolating effects of processed meat from minimally processed meat. Meat is a good source of several essential nutrients, including high quality protein, iron, and vitamin B12. This dietary intervention is designed to investigate the effects of minimally processed meat and further proceeded meat, as part of two different dietary patterns (the typical American dietary pattern and Dietary Guidelines dietary pattern) on outcomes related to chronic diseases.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female
Exclusion Criteria
- •Younger than 25 years old and older than 80 years old at the beginning of the intervention.
- •Body mass index less than 18 or greater than 40 kg/m
- •Blood pressure greater than 160/100 mm Hg or use of medication to treat hypertension for less than 6 months.
- •Use of medications that will affect the study outcomes, including cholesterol lowering medications.
- •Pregnant women, lactating women, women who plan to become pregnant during the study, or women who have given birth during the previous 12 months.
- •Fasting blood glucose over 125 mg/dL or type 2 diabetes requiring medication.
- •Body weight change of 10% in the past 3 months.
- •History of bariatric or other gastrointestinal surgery that would affect digestion.
- •History or presence of diabetes, kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
- •Smokers, vapers, or other tobacco users (within 6 months prior to the start of the study).
- •Use of an antibiotic within 1 month of the start of the study or during the study.
- •Plans to have a colonoscopy during the study.
- •Allergy to any food included in the study menus.
- •Unable or unwilling to give informed consent or communicate with study staff.
- •Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Arms & Interventions
High Healthy Eating Index Diet with Minimally Processed Meat
Participants will consume a diet with a high Healthy Eating Index along with meat that is minimally processed.
Intervention: High Healthy Eating Index Diet with Minimally Processed Meat (Other)
High Healthy Eating Index Diet with Further Processed Meat
Participants will consume a diet with a high Healthy Eating Index along with meat that is further processed.
Intervention: High Healthy Eating Index Diet with Further Processed Meat (Other)
Typical Healthy Eating Index Diet with Minimally Processed Meat
Participants will consume a diet with a typical Healthy Eating Index along with meat that is minimally processed.
Intervention: Typical Healthy Eating Index Diet with Minimally Processed Meat (Other)
Typical Healthy Eating Index Diet with Further Processed Meat
Participants will consume a diet with a typical Healthy Eating Index along with meat that is further processed.
Intervention: Typical Healthy Eating Index Diet with Further Processed Meat (Other)
Outcomes
Primary Outcomes
Betaine Concentration
Time Frame: Day 141
Betaine, which help make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.
TMA (trimethylamine) Concentration
Time Frame: Day 141
TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.
Blood Pressure
Time Frame: Day 141
Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Total Cholesterol Concentration
Time Frame: Day 141
Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
LDL Cholesterol Concentration
Time Frame: Day 141
LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
HDL Cholesterol Concentration
Time Frame: Day 141
HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Apolipoprotein Concentration
Time Frame: Day 141
Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Carnitine Concentration
Time Frame: Day 141
Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.
Choline Concentration
Time Frame: Day 141
Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.
Triglyceride Concentration
Time Frame: Day 141
Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Low Density Lipoprotein particle size
Time Frame: Day 141
Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.
TMAO (trimethylamine N-oxide) Concentration
Time Frame: Day 141
TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.
Lipoprotein(a) (Lp(a)) Concentration
Time Frame: Day 141
Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.
Secondary Outcomes
- Hunger and Satiety(Week 19)
- Gut microbiota(Day 141)
- Glucose Concentration(Day 141)
- IL6 Concentration(Day 141)
- Diet Satisfaction(Week 19)
- C-Reactive Protein (CRP) Concentration(Day 141)
- Bile acid Concentration(Day 141)
- Serum Amyloid A Concentration(Day 141)
- Insulin Concentration(Day 141)
- 24-Hour Dietary Recall(1 to 3 days before Day 1)
Investigators
David Baer
Supervisory Research Physiologist
USDA Beltsville Human Nutrition Research Center