Alzheimer DiseaseNCT05021211
Whole Egg Intake and Choline Concentration in the Aging Brain
An observational study of Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Use of hormone replacement therapy
- Tobacco smokers
- Subjects with MRI contraindications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Keywords
- Choline, Egg Consumption, Alzheimer Disease, Cognitive Impairment, Dementia
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Jun 2021
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Sponsor
- Investigators
- Debra K. Sullivan, PhD, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021211
- Sponsor's protocol ID
- STUDY00146588
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2021
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Egg Intake and Choline Concentration in the Aging Brain
- ClinicalTrials.gov ID
- NCT05021211
- Acronym / sponsor ID
- STUDY00146588
- Conditions
- Alzheimer Disease
- Keywords
- Choline, Egg Consumption, Alzheimer Disease, Cognitive Impairment, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Whole Egg Intake and Cerebral Choline
Time frame: 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)
Association Between Cerebral Choline and Cognition
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra K. Sullivan, PhD, RD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Whole Egg Intake and Cerebral Choline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.