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NCT Number: NCT06261775

Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Lifestyle

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Concentration of phosphatidylcholine in blood

    Time frame: 8 weeks

    Using Microplate Assay

Sponsors and collaborators

Lead sponsor

South Dakota State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Feb 15, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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