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CompletedNCT03109561Updated Jul 23, 2020

Apolipoprotein E (ApoE) and Metabolism

An observational study in Cognitive Function and Healthy, sponsored by Lance Johnson. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Lance Johnson · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
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Study summary

Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.

Read the detailed description

The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.

To more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).

To determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood.

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Conditions studied

  • Cognitive Function
  • Healthy
03

In context

Lead sponsor

This is the only study on the registry with Lance Johnson as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Cognitively normal and are in good overall health.

Inclusion criteria

  • all races/ethnicities
  • ages 18-65
  • cognitively normal
  • good health

Exclusion criteria

Exclusion Criteria:

  • pregnant or breastfeeding.
  • have a bleeding disorder,
  • have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.
  • have a history of alcoholism or drug abuse
  • have a history of schizophrenia or currently suffer from bipolar disorder or major depression.
  • have vision or hearing loss severe enough to interfere with cognitive testing
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherResting State Indirect Calorimetry

    The investigator will measure the amount of oxygen participants breathe in and the amount of carbon dioxide they breathe out using a portable unit. Participants will be asked wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.

  • GeneticApoE

    The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.

  • Diagnostic testMetabolism

    To more accurately measure the amount of carbohydrates, fats and proteins that the participants bodies metabolize, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study). The total amount of urine to be collected is approximately 4 teaspoons.

  • OtherCognitive Challenge

    Participants will be asked to follow simple instructions that are displayed on computer screen.

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What researchers measure

Primary outcomes

  1. Indirect Calorimetry

    Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes

    Time frame: 4 hours

Secondary outcomes

  1. Respiratory Quotient (RQ)

    Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes

    Time frame: 4 hours

Other outcomes

  1. Urea Nitrogen Output

    Improve RQ measure accuracy by determining urinary urea nitrogen output in collected urine samples from these subjects.

    Time frame: 4 hours

  2. Genotype

    Genotype subjects using DNA isolated from collected blood samples.

    Time frame: 4 hours

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Study locations

1 site
  • University of Kentucky Medical Center
    Lexington, Kentucky 40536, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03109561
Lead sponsor
Lance Johnson
Responsible party
Lance Johnson (Principal Investigator, University of Kentucky) — Sponsor-investigator
First posted
Apr 12, 2017
Start date
Apr 24, 2018
Primary completion
Jan 30, 2020
Completion
Jan 30, 2020
Last update
Jul 23, 2020

Study contacts

Lance Johnson1, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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