Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

January 29, 2025 updated by: Moul Dey, South Dakota State University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Brookings, South Dakota, United States, 57007
        • South Dakota State University, Wagner Hall 416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Low UPF no meat
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.
Other: No meat diet
Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.
Experimental: Test
Low UPF with Red meat
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.
Other: No meat diet
Participants were provided with food as part of a meal plan. The research team provided all foods and snacks for the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of phosphatidylcholine in blood
Time Frame: 8 weeks
Using Microplate Assay
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Dakota State University

Investigators

  • Principal Investigator: Moul Dey, Ph.D, South Dakota State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Actual)

February 7, 2024

Study Completion (Estimated)

January 2, 2026

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2401011-EXM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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