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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different types of meat and diets affect health. Participants will try four meal plans, combining high or typical healthy diets with either minimally or further processed meats. The goal is to identify which combination might alter disease risk. Individuals who don't smoke, don't have diabetes or other major health conditions, and are not on certain medications might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how diet impacts health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that consuming large amounts of processed meat can harm health. Studies have found an increased risk of heart disease, type 2 diabetes, and some cancers. Even small amounts, such as one hot dog a day, might raise these risks.

For diets with less processed meat, findings are mixed. Some studies suggest that unprocessed red meat might slightly increase the risk of certain cancers and heart disease. However, diets scoring high on the Healthy Eating Index (HEI), which emphasize overall healthy eating habits, can lead to better health, even with some red meat. These diets may also lower the risk of mental health issues, such as depression and PTSD.

When considering participation in a study like this, it's important to weigh these potential risks. While high HEI diets appear beneficial, processed meats have been linked to several health problems. Always consult a doctor before joining any study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different diets and meat processing methods affect health, offering insights beyond typical dietary guidelines. Most dietary studies focus on nutrient balance and general health outcomes, but this trial uniquely examines the impact of meat processing levels combined with dietary quality. By comparing high and typical Healthy Eating Index diets with both minimally and further processed meats, the trial could reveal specific effects of meat processing on health. This could lead to more tailored dietary recommendations that optimize health benefits in ways current guidelines do not fully address.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of different diets on health. Studies have shown that consuming large amounts of red and processed meats links to a higher risk of health problems like type 2 diabetes and heart disease. Reducing processed meat intake could lead to significant health benefits, such as lowering these risks. Conversely, higher scores on the Healthy Eating Index (HEI), which measures diet quality, correlate with fewer mental health issues like depression, regardless of red meat consumption. Research indicates that diets high in processed meats can harm health, while those with less processed meats are generally more beneficial. This trial will test various diets, including those with high HEI scores and different levels of meat processing, to evaluate their impact on health. ^{1 2 5 6 7}

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

Industry Sponsor

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Industry Sponsor

National Cattlemen's Beef Association

Collaborator

Trials

26

Recruited

1,300+

Citations

1. nature.com nature.com/articles/s41598-025-18907-w

Red meat consumption in higher healthy eating index diets ... Higher HEI scores, irrespective of red meat consumption, were associated with reduced odds of depression (logOR = −2.22), PTSD (logOR = −3.80), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6971786/

Red and Processed Meats and Health Risks: How Strong ... Considerable evidence from long-term prospective cohort studies has demonstrated that diets high in red and processed meats are associated with increased risk ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2542519624001189

Articles Estimated effects of reductions in processed meat ... Reductions in processed meat consumption could result in substantial health co-benefits in the USA by reducing the incidence of type 2 diabetes, cardiovascular ...

4. zerocarbon-analytics.org zerocarbon-analytics.org/nature/the-cost-of-red-and-processed-meat/

The cost of red and processed meat: Impacts on health and ... Reducing the disease burden caused by processed meat by 30% could free up USD 21 billion annually in healthcare spending in the US, USD 2.2 billion in Germany, ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1354287/full

Global, regional, and national burden of diet high in ... The objective of this study is to explore the prevalence and attributable burden of diet high in processed meat (DHIPM) in global, regional, and national level

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7399967/

Ultra-Processed Foods and Health Outcomes: A Narrative ... 37 found dietary UPF exposure associated with at least one adverse health outcome. Among adults, these included overweight, obesity and cardio-metabolic risks.

7. bmj.com bmj.com/content/384/bmj-2023-077310

Ultra-processed food exposure and adverse health outcomes Conclusions Greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, ...