Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

Healthy Lifestyle Clinical Trial

Official title:

Effect of Minimally Processed Animal Protein Within the Dietary Guidelines for Americans on Biomarkers for Cognitive Decline

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06261775
• Other study ID #: IRB-2401011-EXM
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: January 2, 2026

Study information

• Verified date: February 2024
• Source: South Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 dietary guideline-based diet 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: January 2, 2026
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Generally, good health status based on one routine physical in the past 15 months, current health status

• Normal HbA1C, weigh 110 lb or more

• Age 65 years or more, generally healthy, all races and both sexes

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

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

Exclusion Criteria:

• Medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use

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

• Impaired kidney functions

• Active history of cancer, diabetes, heart, liver, and kidney diseases

• Major gastrointestinal disorders in the past 3 months

• History of heart attacks or stroke

• Unable to meet in-person visit requirements for dining, picking up meals, and tests

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

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

• If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverages during the study period.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy Lifestyle

Intervention

Other:
• Red meat-based meal
Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.
• Lacto-ovo-vegetarian meal
Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.

Locations

Country	Name	City	State
United States	South Dakota State University, Wagner Hall 416	Brookings	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of phosphatidylcholine in blood	Using Microplate Assay	8 weeks