Whole Egg Intake and Choline Concentration in the Aging Brain

NCT ID: NCT05021211

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Egg Consumers

Participants who consume fewer than 1 whole egg per week

No interventions assigned to this group

Moderate Egg Consumers

Participants who consume 5-9 whole eggs per week

No interventions assigned to this group

High Egg Consumers

Participants who consumes great than or equal to 14 whole eggs per week

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Egg Nutrition Center

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Debra K. Sullivan, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00146588

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lycopene in Healthy Male Participants
NCT00450957 COMPLETED PHASE1
Lycopene In Preventing of Prostate Cancer
NCT00006078 COMPLETED PHASE1
Soy and Isoflavones Effect on Bone
NCT00668447 COMPLETED PHASE4