Whole Egg Intake and Choline Concentration in the Aging Brain

Alzheimer Disease Clinical Trial

Official title:

Whole Egg Intake and Choline Concentration in the Aging Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021211
• Other study ID #: STUDY00146588
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: Aaron Smith, MS
• Phone: 913-229-5935
• Email: asmith71[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association Between Whole Egg Intake and Cerebral Choline	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)	Baseline
Primary	Association Between Cerebral Choline and Cognition	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.	Baseline