Meat and Dietary Pattern Study

Beltsville Human Nutrition Research Center (BHNRC)

Status: Active, not recruiting

Conditions: Healthy Volunteers

Treatments: Other: Typical Healthy Eating Index Diet with Further Processed Meat; Other: High Healthy Eating Index Diet with Further Processed Meat; Other: Typical Healthy Eating Index Diet with Minimally Processed Meat; Other: High Healthy Eating Index Diet with Minimally Processed Meat

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05589389

HS68 - Meat And Pattern Study

Details and patient eligibility

About

The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 4 patient groups

High Healthy Eating Index Diet with Minimally Processed Meat

Experimental group

Description:

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

Treatment:

Other: High Healthy Eating Index Diet with Minimally Processed Meat

High Healthy Eating Index Diet with Further Processed Meat

Experimental group

Description:

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

Treatment:

Other: High Healthy Eating Index Diet with Further Processed Meat

Typical Healthy Eating Index Diet with Minimally Processed Meat

Experimental group

Description:

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

Treatment:

Other: Typical Healthy Eating Index Diet with Minimally Processed Meat

Typical Healthy Eating Index Diet with Further Processed Meat

Experimental group

Description:

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

Treatment:

Other: Typical Healthy Eating Index Diet with Further Processed Meat