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Clinical Trials/NCT05021211
NCT05021211
Completed
Not Applicable

Whole Egg Intake and Choline Concentration in the Aging Brain

University of Kansas Medical Center1 site in 1 country60 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University of Kansas Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Association Between Cerebral Choline and Cognition
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
May 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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)

Study Sites (1)

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