Clinical trial NCT05021211: Whole Egg Intake and Choline Concentration in the Aging Brain
Official title: Whole Egg Intake and Choline Concentration in the Aging Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Choline
Egg Consumption
Alzheimer Disease
Cognitive Impairment
Dementia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2021-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Association Between Whole Egg Intake and Cerebral Choline
timeFrame: Baseline
measure: Association Between Cerebral Choline and Cognition
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Debra K. Sullivan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: