Meat and Dietary Pattern Study

Not Applicable

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Other: High Healthy Eating Index Diet with Further Processed Meat; Other: Typical Healthy Eating Index Diet with Further Processed Meat; Other: High Healthy Eating Index Diet with Minimally Processed Meat; Other: Typical Healthy Eating Index Diet with Minimally Processed Meat

• Registration Number: NCT05589389
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

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 Timeline

• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-21
• Study Start: 2022-10-26
• Primary Completion: 2023-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Healthy Eating Index Diet with Further Processed Meat	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.
Typical Healthy Eating Index Diet with Further Processed Meat	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.
High Healthy Eating Index Diet with Minimally Processed Meat	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.
Typical Healthy Eating Index Diet with Minimally Processed Meat	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.

Primary Outcome Measures

Name	Time	Method
Betaine Concentration	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	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	Day 141	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.
Total Cholesterol Concentration	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	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	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Hunger and Satiety	Week 19	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.
Gut microbiota	Day 141	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).
Glucose Concentration	Day 141	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.
IL6 Concentration	Day 141	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.
Diet Satisfaction	Week 19	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.
C-Reactive Protein (CRP) Concentration	Day 141	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.
Bile acid Concentration	Day 141	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.
Serum Amyloid A Concentration	Day 141	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.
Insulin Concentration	Day 141	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.
24-Hour Dietary Recall	1 to 3 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).

Trial Locations

Locations (1)

USDA-ARS, Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States