Diet and Meat Processing Impact on Health

Overseen By Janet A. Novotny, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: USDA Beltsville Human Nutrition Research Center

Must not be taking: Cholesterol medications, Antibiotics

Disqualifiers: Diabetes, Kidney disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 20 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that could affect the study outcomes, such as cholesterol-lowering medications.

Is the diet with processed and unprocessed meats safe for humans?

Research suggests that eating processed meats is linked to a higher risk of heart disease and cancer, while unprocessed meats do not show the same risks. It's important to be cautious with processed meats due to their high sodium and preservatives. ^{1 2 3 4 5}

How does the treatment in the 'Diet and Meat Processing Impact on Health' trial differ from other treatments?

This treatment focuses on the impact of diet, specifically meat consumption and processing, on health outcomes like mortality and chronic diseases, which is unique compared to standard medical treatments that often involve medications or surgical interventions. It emphasizes dietary changes, such as reducing processed meat intake and substituting it with healthier protein sources like poultry, fish, and nuts, to potentially lower the risk of diseases like cardiovascular and respiratory conditions. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment High Healthy Eating Index Diet with Further Processed Meat?

Research suggests that processed meat intake is linked to higher overall mortality, including cardiovascular and respiratory deaths. However, replacing processed meat with other protein sources like poultry, fish, and nuts is associated with lower mortality risks. ^{2 3 8 10 11}

Who Is on the Research Team?

David J Baer, Ph.D.

Principal Investigator

USDA Beltsville Human Nutrition Research Center

Janet A Novotny, Ph.D.

Principal Investigator

USDA Beltsville Human Nutrition Research Center

Are You a Good Fit for This Trial?

This trial is for men and women between the ages of 25-80 who are generally healthy. It's not suitable for those with a history of serious diseases like diabetes, kidney or liver issues, certain cancers, or heart problems. Smokers and heavy drinkers can't join either. Participants should not be on medications that affect cholesterol levels and must have stable body weight.

Inclusion Criteria

I am either male or female.

Exclusion Criteria

My fasting blood sugar is over 125 mg/dL or I am on medication for type 2 diabetes.

Pregnant women, lactating women, women who plan to become pregnant during the study, or women who have given birth during the previous 12 months

Body weight change of 10% in the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 to 3 days

1 visit (in-person)

Baseline Assessment

24-hour dietary recall interview conducted to assess food intake prior to the start of the dietary intervention

1 week

1 visit (in-person)

Treatment

Participants consume diets with different types of meat and dietary patterns to assess effects on cardiovascular health

20 weeks

Regular visits for dietary monitoring and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Healthy Eating Index Diet with Further Processed Meat
• High Healthy Eating Index Diet with Minimally Processed Meat
• Typical Healthy Eating Index Diet with Further Processed Meat
• Typical Healthy Eating Index Diet with Minimally Processed Meat

Trial Overview The study explores how different types of meat (minimally processed vs further processed) consumed within two dietary patterns (high vs typical Healthy Eating Index diets) impact disease risk factors in healthy adults.

How Is the Trial Designed?

Group I: Typical Healthy Eating Index Diet with Minimally Processed Meat Experimental Treatment 1 Intervention

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

Group II: Typical Healthy Eating Index Diet with Further Processed Meat Experimental Treatment 1 Intervention

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

Group III: High Healthy Eating Index Diet with Minimally Processed Meat Experimental Treatment 1 Intervention

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

Group IV: High Healthy Eating Index Diet with Further Processed Meat Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

USDA Beltsville Human Nutrition Research Center

Lead Sponsor

Trials

56

Recruited

5,300+

National Cattlemen's Beef Association

Collaborator

Trials

26

Recruited

1,300+

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

[Reduction of red and processed meats in the Spanish population: What is its impact on total and cardiovascular mortality?] [2021]

2. England pubmed.ncbi.nlm.nih.gov

Meat consumption and diet quality and mortality in NHANES III. [2013]

3. England pubmed.ncbi.nlm.nih.gov

The World Cancer Research Fund report 2007: A challenge for the meat processing industry. [2011]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Red meat, processed meat, and other dietary protein sources and risk of overall and cause-specific mortality in The Netherlands Cohort Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The development, application, and validation of a Healthy eating index for Australian Adults (HEIFA-2013). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Processing of meats and cardiovascular risk: time to focus on preservatives. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Associations of meat consumption and changes with all-cause mortality in hypertensive patients during 11.4-year follow-up: Findings from a population-based nationwide cohort. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Red and processed meat consumption and risk of incident cardiovascular disease and mortality: Isfahan cohort study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Processed meat: the real villain? [2017]

10. Spain pubmed.ncbi.nlm.nih.gov

SYSTEMATIC REVIEW OF HEALTHY EATING INDEXES IN ADULTS AND ELDERLY: APPLICABILITY AND VALIDITY. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Effects of Removing a Serving of Meat or Poultry from Healthy Dietary Patterns-A Dietary Modeling Study. [2023]