Whole Egg Intake and Choline Concentration in the Aging Brain

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05021211
Collaborator
Egg Nutrition Center (Other)
60
1
30
2

Study Details

Study Description

Brief Summary

By doing this study, researchers hope to learn to see if there is relationship between whole egg consumption and brain choline status. Additionally, researchers also plan to see if there is a relationship between brain choline status and cognition.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants will come to the research center for 2 different visits. Visit 1 will include anthropometric measurements, surveys, and a cognitive test. Approximately 7-10 days after visit 1, participants will come back to the research center for visit 2. At visit 2, participants will return surveys and a MRI scan will be performed to measure brain choline status. Potential participants need to be located within the Kansas City metro area.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Whole Egg Intake and Choline Concentration in the Aging Brain
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Low Egg Consumers

    Participants who consume fewer than 1 whole egg per week

    Moderate Egg Consumers

    Participants who consume 5-9 whole eggs per week

    High Egg Consumers

    Participants who consumes great than or equal to 14 whole eggs per week

    Outcome Measures

    Primary Outcome Measures

    1. Association Between Whole Egg Intake and Cerebral Choline [Baseline]

      The investigators will recruit a variety of whole egg consumers. Egg consumption will be validated with a 7-day food record 1 week before the MRI. Cerebral choline levels are measured by magnetic resonance spectroscopy (MRS)

    2. Association Between Cerebral Choline and Cognition [Baseline]

      The investigators will test the association between cerebral choline as measured by MRS and cognition. Cognition will be measured by the NIH ToolBox cognitive battery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Aged between 60 - 85 years of age

    • Good general health with no concomitant diseases

    • Cognitively normal as defined as Mini-mental state examination (MMSE) score ≥ 25

    • BMI range: 20 - 40 kg/m2

    Exclusion Criteria:
    • Presence of central neurological disease (e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer's, Parkinson's)

    • Prior major head trauma with loss of consciousness

    • Presence of active unstable and life-threatening illness (e.g., cancer)

    • Presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score > 6)

    • Presence of diabetes mellitus or use of anti-diabetic agents

    • Use of psychoactive and investigational medications

    • Use of hormone replacement therapy

    • Tobacco smokers

    • Subjects with MRI contraindications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • University of Kansas Medical Center
    • Egg Nutrition Center

    Investigators

    • Principal Investigator: Debra K. Sullivan, PhD, RD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT05021211
    Other Study ID Numbers:
    • STUDY00146588
    First Posted:
    Aug 25, 2021
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Kansas Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 20, 2021