Whole Egg Intake and Choline Concentration in the Aging Brain

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT05021211
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States