Aging Clinical Trial
— BrainFitOfficial title:
Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1
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 |
Verified date | November 2022 |
Source | Pennington Biomedical Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Pennington Biomedical Research Center |
United States,
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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