Animal Protein for Cognitive Impairment

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: South Dakota State University

Must not be taking: Probiotics, Antibiotics, others

Disqualifiers: Cancer, Diabetes, Heart, Liver, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding lean animal protein to a healthy diet can improve nutrition and slow memory loss in older adults. The focus is on individuals who already consume meat regularly and are generally in good health. Participants will be divided into two groups: one will continue with a low-processed food diet without meat, while the other will include red meat. Ideal candidates have recently undergone a routine health checkup and do not have major health issues such as diabetes or heart disease. As an unphased trial, this study allows participants to contribute to important nutritional research that could inform future dietary guidelines.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications, as the trial excludes participants who use medications.

What prior data suggests that minimally processed animal protein is safe for cognitive health?

Research continues to explore the safety of minimally processed animal protein, such as red meat, for health. Some studies suggest that consuming large amounts of processed red meats, like bacon and sausage, might link to a higher risk of memory problems or dementia. However, these findings primarily concern processed meats, not minimally processed ones.

Other studies on minimally processed red meat have shown improvements in health markers related to brain function, suggesting potential benefits for brain health. While these results are encouraging, ongoing research is necessary to fully understand the safety and long-term effects.

Prospective trial participants should consult a healthcare provider for advice tailored to their personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using minimally processed animal protein for cognitive impairment because it takes a fresh approach compared to traditional treatments like medications or cognitive therapies. Most current treatments target cognitive functions through chemical means or mental exercises. However, this approach explores the potential cognitive benefits of diet, specifically with red meat, which is rich in nutrients like iron and vitamin B12 that are essential for brain health. This novel dietary angle could offer a more natural and holistic way to support cognitive function.

What evidence suggests that minimally processed animal protein might be an effective treatment for cognitive impairment?

This trial will compare the effects of a diet low in ultra-processed foods (UPF) with and without minimally processed red meat on cognitive impairment. Research has shown that consuming more processed red meat, such as bacon and sausages, links to a higher risk of dementia and poorer brain function. Studies indicate that diets high in these meats connect to a greater chance of mental decline. Eating an extra serving of processed meat each day can accelerate brain aging. However, some evidence suggests that diets rich in plant-based foods and healthy fats, which may include small amounts of less processed red meat, could benefit brain health. Although these negative findings do not focus on minimally processed red meat, caution is still advised due to potential risks. ^{1 2 5 6 7}

Who Is on the Research Team?

Moul Dey, Ph.D

Principal Investigator

South Dakota State University

Are You a Good Fit for This Trial?

This trial is for older adults who are at risk of cognitive decline and nutritional deficiencies. Participants should be interested in following a meal plan based on dietary guidelines, which includes lean animal protein. Specific eligibility details are not provided.

Inclusion Criteria

Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection

Generally practicing a meat-based dietary pattern, do not have any special dietary requirements

I've had a physical exam in the last 15 months and am generally healthy.

Exclusion Criteria

If they had not had a routine health checkup 12 months before recruitment

Not on any special diet within 3 months of recruitment, and do not intend to lose weight

Any mental health condition affecting the ability to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a diet with minimally processed animal protein to assess its effect on cognitive decline biomarkers

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minimally Processed Animal Protein

Trial Overview The study is testing whether adding lean animal protein to a diet that follows dietary guidelines can improve nutrient levels and slow down signs of cognitive decline in older adults. It's a retrospective study using data from an earlier feeding trial.

How Is the Trial Designed?

Group I: Test Experimental Treatment 2 Interventions

Low UPF with Red meat

Group II: Control Experimental Treatment 2 Interventions

Low UPF no meat

Who Is Running the Clinical Trial?

South Dakota State University

Lead Sponsor

Trials

21

Recruited

10,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39813632/

Long-Term Intake of Red Meat in Relation to Dementia Risk ... Higher intake of red meat, particularly processed red meat, was associated with a higher risk of developing dementia and worse cognition.

2. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/red-meat-increases-risk-of-dementia

Red Meat Consumption Increases Risk of Dementia and ... Researchers found that diets high in processed meats, including bacon, hot dogs and sausage, were associated with a 13 percent higher risk of dementia.

3. health.harvard.edu health.harvard.edu/mind-and-mood/harvard-scientists-red-meat-tied-to-increased-dementia-risk

Harvard scientists: Red meat tied to increased dementia risk For every extra serving per day of processed meat, there was an increase of 1.6 years in the speed of cognitive aging. For unprocessed red meat ...

4. medrxiv.org medrxiv.org/content/medrxiv/early/2025/08/13/2025.08.11.25333443.full.pdf

Effects of Minimally Processed Red Meat Within a Plant- ... Diets rich in plant-based foods and healthy fats like the Mediterranean, DASH, and MIND diets, have been associated with reduced cognitive ...

5. observatoireprevention.org observatoireprevention.org/en/2025/08/05/red-meat-consumption-may-increase-the-risk-of-cognitive-decline-and-dementia/

Red Meat Consumption May Increase the Risk of Cognitive ... Here again, the results show that processed meats are associated with a 14% increased risk of cognitive decline in the highest consumers (≥ 0.25 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06261775

Effect of Minimally Processed Animal Protein on ... Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline. ClinicalTrials.gov ID NCT06261775. Sponsor South Dakota State University.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40832369/

Effects of Minimally Processed Red Meat Within a Plant ... Improvements in cognitive related metabolic biomarkers were observed across both arms. Fasting insulin declined more after MPP ( p < 0.001), ...