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OpenTrials
Completed

NCT Number: NCT05021211

Whole Egg Intake and Choline Concentration in the Aging Brain

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Association Between Whole Egg Intake and Cerebral Choline

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Egg Nutrition Center

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2021
Registry last updated
Aug 14, 2024

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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