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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06261775
Other study ID # IRB-2401011-EXM
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 30, 2024
Est. completion date January 2, 2026

Study information

Verified date February 2024
Source South Dakota State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 dietary guideline-based diet 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date January 2, 2026
Est. primary completion date February 7, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States South Dakota State University, Wagner Hall 416 Brookings South Dakota

Sponsors (1)

Lead Sponsor Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of phosphatidylcholine in blood Using Microplate Assay 8 weeks
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