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Completed

NCT Number: NCT04645134

Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Brain Health Assessments

Behavioral

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.

Primary outcomes

  1. Plasma concentrations of GPLD1

    Time frame: 1 day

    Plasma GPLD1 (by a blood draw) is performed.

Secondary outcomes

  1. Physical activity level

    Time frame: 7 days

    Physical activity level assessment (by accelerometry) is performed.

  2. Total grey matter volume

    Time frame: 1 day

    Total grey matter volume (by structural MRI) is performed.

  3. Brain activity and function

    Time frame: 1 day

    Brain activity and function (by functional MRI) during execution of two cognitive tasks (Stroop Task and Attention Network Task (ANT)) is performed.

  4. Cognitive function

    Time frame: 1 day

    Cognitive function testing (using the NIH Toolbox Cognitive Battery) is performed.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: BrainFit

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2020
Registry last updated
Nov 16, 2022

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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