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Completed

NCT Number: NCT03109561

Apolipoprotein E (ApoE) and Metabolism

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.

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Key information

Conditions

Cognitive Function Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resting State Indirect Calorimetry

Other

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.

ApoE

Genetic

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

Metabolism

Diagnostic Test

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.

Cognitive Challenge

Other

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

Primary outcomes

  1. Indirect Calorimetry

    Time frame: 4 hours

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

Secondary outcomes

  1. Respiratory Quotient (RQ)

    Time frame: 4 hours

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

Other outcomes

  1. Urea Nitrogen Output

    Time frame: 4 hours

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

  2. Genotype

    Time frame: 4 hours

    Genotype subjects using DNA isolated from collected blood samples.

Sponsors and collaborators

Lead sponsor

Lance Johnson

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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