Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

NCT06261775 | Active Not Recruiting

• 1 other identifier: IRB-2401011-EXM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Outcome Measures

Primary Outcomes (1)

• Concentration of phosphatidylcholine in blood

  Using Microplate Assay

  8 weeks

Study Arms (2)

Control

OTHER

Low UPF no meat

Other: Red meat-based meal; Other: No meat diet

Test

EXPERIMENTAL

Low UPF with Red meat

Other: Red meat-based meal; Other: No meat diet

Interventions

Red meat-based meal OTHER

Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.

Control; Test

No meat diet OTHER

Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.

Control; Test

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead

Study Sites (1)

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Location

Related Publications (2)

• Vaezi S, de Vargas BO, Weidauer L, Freeling JL, Dey M. Effects of Minimally Processed Red Meat within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. Curr Dev Nutr. 2025 Dec 10;10(1):107615. doi: 10.1016/j.cdnut.2025.107615. eCollection 2026 Jan.

  PMID: 41551721 DERIVED

• Vaezi S, de Vargas BO, Freeling JL, Weidauer L, Dey M. Effects of Minimally Processed Red Meat Within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333443. doi: 10.1101/2025.08.11.25333443.

  PMID: 40832369 DERIVED

Study Officials

• Moul Dey, Ph.D

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: January 30, 2024
• Primary Completion: February 7, 2024
• Study Completion: January 2, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)