Meat and Dietary Pattern Study

NCT ID: NCT05589389

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2025-07-30

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

High Healthy Eating Index Diet with Minimally Processed Meat

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

High Healthy Eating Index Diet with Further Processed Meat

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Typical Healthy Eating Index Diet with Minimally Processed Meat

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Typical Healthy Eating Index Diet with Further Processed Meat

Intervention Type: OTHER

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

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 Type: 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 Type: 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 Type: 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 Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cattlemen's Beef Association

INDUSTRY

Sponsor Role: collaborator

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

David Baer

Supervisory Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J. Baer, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Janet A. Novotny, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Locations

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

Other Identifiers

HS68 - Meat And Pattern Study

Identifier Type: -

Identifier Source: org_study_id