Healthy Volunteers
Conditions
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.
Interventions
OTHERHigh 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.
OTHERHigh 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.
OTHERTypical 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.
OTHERTypical 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.
Sponsors
USDA Beltsville Human Nutrition Research Center
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Subjects will be assigned to one or 24 possible treatment sequences.
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
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/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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carnitine Concentration | Day 1 | Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health. |
| Choline Concentration | Day 1 | Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health. |
| Betaine Concentration | Day 1 | Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health. |
| TMA (trimethylamine) Concentration | Day 1 | TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health. |
| TMAO (trimethylamine N-oxide) Concentration | Day 1 | TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health. |
| Total Cholesterol Concentration | Day 1 | 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 | Day 1 | LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health. |
| HDL Cholesterol Concentration | Day 1 | HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health. |
| Triglyceride Concentration | Day 1 | Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health. |
| Apolipoprotein Concentration | Day 1 | Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health. |
| Lipoprotein(a) (Lp(a)) Concentration | Day 1 | Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health. |
| Low Density Lipoprotein particle size | Day 1 | Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health. |
| Blood Pressure | Day 1 | Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota | Day 1 | 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). |
| Bile acid Concentration | Day 1 | 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. |
| Glucose Concentration | Day 1 | Glucose in blood will be measured in mg/dL as a reflection of glucose regulation. |
| Insulin Concentration | Day 1 | Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation. |
| Diet Satisfaction | Week 1 | Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction. |
| Hunger and Satiety | Week 1 | 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. |
| 24-Hour Dietary Recall | 5 to 7 days before Day 1 | 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). |
| IL6 Concentration | Day 1 | IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml. |
| C-Reactive Protein (CRP) Concentration | Day 1 | C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml. |
| Serum Amyloid A Concentration | Day 1 | Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid J. Baer, PhD
USDA Beltsville Human Nutrition Research Center
PRINCIPAL_INVESTIGATORJanet A. Novotny, PhD
USDA Beltsville Human Nutrition Research Center
Outcome results
None listed