Whole Egg Intake and Choline Concentration in the Aging Brain

NCT05021211 | Completed

• 1 other identifier: STUDY00146588
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Choline; Egg Consumption; Alzheimer Disease; Cognitive Impairment; Dementia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the greater Kansas City. Recruitment for this research opportunity by email, community flyers, and through the social media platform, Nextdoor. Researchers will also use recruitment databases including the Recruitment and Eligibility Database hosted by the KU Alzheimer's Disease Center (P30 AG035982) and the Pioneers Participant Registry hosted by KU Medical Center and the University of Kansas Hospital. Both of these registries consist of highly characterized, community-dwelling individuals that have given prior consent to be directly contacted for research opportunities.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Debra K. Sullivan, PhD, RD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: June 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (1)