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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a healthy diet following macronutrient recommendations for Americans will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same.

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 data supports the effectiveness of the treatment Minimally Processed Animal Protein for cognitive impairment?

Research suggests that adequate protein intake is important for brain health, and low protein levels are linked to cognitive decline. Studies have shown that higher protein consumption may reduce the risk of brain changes associated with Alzheimer's disease, indicating that protein-rich diets could help maintain cognitive function in older adults. ^{1 2 3 4 5}

Is animal protein safe for human consumption?

Research on various animal proteins, including bovine-plasma protein, suggests they can be consumed in relatively high amounts without causing gastrointestinal issues or gut barrier problems. However, a small increase in blood pressure was noted with bovine-plasma protein, possibly due to its salt content, indicating a potential health concern. ^{3 6 7 8 9}

How does the treatment Minimally Processed Animal Protein differ from other treatments for cognitive impairment?

Minimally Processed Animal Protein is unique because it focuses on using animal-derived proteins, which may influence cognitive function by affecting brain-related mechanisms such as nerve growth and oxidative stress. Unlike other treatments, it emphasizes the potential benefits of specific dietary proteins on cognitive health, which is a novel approach compared to standard pharmaceutical interventions. ^{2 3 10 11 12}

Research Team

Moul Dey, Ph.D

Principal Investigator

South Dakota State University

Eligibility Criteria

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

I use probiotics, long-term antibiotics, or have habits of tobacco, drug, or alcohol use.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Novel Nutrition-Related Multivariate Biomarker for Mild Cognitive Impairment Based on the Plasma Free Amino Acid Profile. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Decreased circulating branched-chain amino acids are associated with development of Alzheimer's disease in elderly individuals with mild cognitive impairment. [2023]

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

Soy protein increases cognitive level in mice by modifying hippocampal nerve growth, oxidative stress, and intestinal microbiota. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effect of dietary supplementation with multinutrient soy flour on body composition and cognitive function in elderly individuals at the risk of low protein: a randomized, double-blind, placebo-controlled study. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Associations of Dietary Protein and Fiber Intake with Brain and Blood Amyloid-β. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Processed animal proteins (PAPs) in animal nutrition: Assessment of the chemical risk of essential and non-essential elements. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating and comparing tolerance, nutritional quality and bio-functional activity of bovine-plasma, corn and whey proteins, outcomes of a randomized double blind controlled trial. [2023]

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

Food proteins as a source of bioactive peptides with diverse functions. [2022]

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

Subchronic feeding, allergenicity, and genotoxicity safety evaluations of single strain bacterial protein. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Whey Protein Hydrolysate Renovates Age-Related and Scopolamine-Induced Cognitive Impairment. [2023]

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

A Hydrolyzed Chicken Extract CMI-168 Enhances Learning and Memory in Middle-Aged Mice. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Supplementation of a Whey Peptide Rich in Tryptophan-Tyrosine-Related Peptides on Cognitive Performance in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study. [2023]