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Apolipoprotein E (ApoE) and Metabolism

APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03109561
Enrollment
100
Registered
2017-04-12
Start date
2018-04-24
Completion date
2020-01-30
Last updated
2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Healthy

Brief 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.

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.

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.

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

Sponsors

Lance Johnson
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Indirect Calorimetry4 hoursMeasure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes

Secondary

MeasureTime frameDescription
Respiratory Quotient (RQ)4 hoursMeasure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes

Other

MeasureTime frameDescription
Urea Nitrogen Output4 hoursImprove RQ measure accuracy by determining urinary urea nitrogen output in collected urine samples from these subjects.
Genotype4 hoursGenotype subjects using DNA isolated from collected blood samples.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026