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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04645134
Other study ID # PBRC 2020-050
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date March 17, 2022

Study information

Verified date November 2022
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators are conducting a cross-sectional, observational study to investigate whether plasma GPLD1 concentrations are associated with higher cognitive function and better brain structure and function in two groups of older adults with high or low levels of physical activity.


Description:

This is a cross-sectional, observational study which will enroll up to 28 healthy, older adults (65-85 y, BMI 20-35 kg/m2), and stratify by current self-reported physical activity level (equal inactive vs. equal highly active). Aim 1: Investigate whether physical activity level is associated with GPLD1. Aim 2: Investigate whether cognitive function and brain structure/function are associated with GPLD1.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date March 17, 2022
Est. primary completion date March 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria: - Ages 65-85 y (inclusive) - Body mass index (BMI) of 20-35 kg/m2 (inclusive) - Willing to have blood and data stored for future research use Exclusion Criteria: - History of clinically diagnosed diabetes (Type 1 or 2) or a fasting blood glucose >126 mg/dL - Diagnosed Alzheimer's disease, dementia, or related-brain diseases - Chronic use of atypical antipsychotic or bipolar medications - Initiation of novel pharmacotherapy agents (such as antidepressant, hypertension, or dyslipidemia) within the last 3 months - Uncontrolled hypertension (blood pressure >160 systolic or >110 diastolic) - Asthma that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration - Emphysema that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration - Current alcohol use exceeding 14 drinks per week in women, exceeding 21 drinks per week in men, having treatment for alcohol abuse in the last year, or having treatment for alcohol abuse more than 1 year ago (but with inability to refrain from alcohol in the past year) - Use of illegal drugs or marijuana within 1-month of completing a Screening Visit; treatment for drug addiction in the 1-year or having treatment for drug addiction >1-year ago, but with an inability to refrain from the drug of addiction in the 1-year - Unwilling to abstain from illegal drugs and marijuana for the duration of the study - Contraindication for MRI (e.g., metal objects, claustrophobia, etc.) - Psychotic mental illness (e.g., schizophrenia, bipolar, on-and- off use of anti-psychotic medication) - History of cardiovascular disease (or diseases of the heart, lungs, or blood) that limits participation in moderate to vigorous physical activity - History of liver, blood, kidney, thyroid or other diseases that limits moderate to vigorous physical activity at the time of enrollment - Cancer that limits moderate to vigorous physical activity - Treatment with systemic immunosuppressant medication - Taking adrenergic stimulants (e.g., amphetamine) or adrenergic blockers (e.g., Propanolol) that will alter metabolic rate - Have plans to substantially alter their current level of physical activity over the next 1-month

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brain Health Assessments
The investigators are enrolling up to 28 healthy, older adults (ages 65-85 y, BMI 20-35 kg/m2) stratified by current physical activity level (equal inactive vs. equal highly active). Each physical activity group (inactive and highly active) will undergo a blood draw, body composition, resting metabolic rate, cognitive testing, and magnetic resonance (MR) imaging.

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma concentrations of GPLD1 Plasma GPLD1 (by a blood draw) is performed. 1 day
Secondary Physical activity level Physical activity level assessment (by accelerometry) is performed. 7 days
Secondary Total grey matter volume Total grey matter volume (by structural MRI) is performed. 1 day
Secondary Brain activity and function Brain activity and function (by functional MRI) during execution of two cognitive tasks (Stroop Task and Attention Network Task (ANT)) is performed. 1 day
Secondary Cognitive function Cognitive function testing (using the NIH Toolbox Cognitive Battery) is performed. 1 day
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