Apolipoprotein E (ApoE) and Metabolism

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109561
• Other study ID #: 17-0202-F1G
• Status: Completed
• Start date: April 24, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Healthy

Intervention

Other:
• Resting 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.

Genetic:
• ApoE
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 Test:
• Metabolism
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.

Other:
• Cognitive Challenge
Participants will be asked to follow simple instructions that are displayed on computer screen.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Lance Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urea Nitrogen Output	Improve RQ measure accuracy by determining urinary urea nitrogen output in collected urine samples from these subjects.	4 hours
Other	Genotype	Genotype subjects using DNA isolated from collected blood samples.	4 hours
Primary	Indirect Calorimetry	Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes	4 hours
Secondary	Respiratory Quotient (RQ)	Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes	4 hours