Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

NCT ID: NCT06261775

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2026-01-02

Brief Summary

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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

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Conditions

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Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Low UPF no meat

Group Type OTHER

Red meat-based meal

Intervention Type OTHER

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

No meat diet

Intervention Type OTHER

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

Test

Low UPF with Red meat

Group Type EXPERIMENTAL

Red meat-based meal

Intervention Type OTHER

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

No meat diet

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Dakota State University

OTHER

Sponsor Role lead

Responsible Party

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Moul Dey

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moul Dey, Ph.D

Role: PRINCIPAL_INVESTIGATOR

South Dakota State University

Locations

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South Dakota State University, Wagner Hall 416

Brookings, South Dakota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40832369 (View on PubMed)

Other Identifiers

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IRB-2401011-EXM

Identifier Type: -

Identifier Source: org_study_id

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