Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

Not Applicable

Active, not recruiting

• Conditions: Healthy Lifestyle
• Interventions: Other: Red meat-based meal; Other: Lacto-ovo-vegetarian meal

• Registration Number: NCT06261775
• Lead Sponsor: South Dakota State University

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Primary Completion: 2024-02-07
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Study Completion: 2026-01-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Red meat-based meal	Lacto-ovo-vegetarian meal
Test	Red meat-based meal	Red meat-based meal
Test	Lacto-ovo-vegetarian meal	Red meat-based meal
Control	Lacto-ovo-vegetarian meal	Lacto-ovo-vegetarian meal

Primary Outcome Measures

Name	Time	Method
Concentration of phosphatidylcholine in blood	8 weeks	Using Microplate Assay

Trial Locations

Locations (1)

South Dakota State University, Wagner Hall 416; 🇺🇸 Brookings, South Dakota, United States