AgingBrainFitNCT04645134
Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1
An observational study of Aging and Cognitive Dysfunction, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Dysfunction
- What is being tested?
- Brain Health Assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 17 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Up to 28 healthy, older adults (ages 65-85 y, BMI 20-35 kg/m2) stratified by current physical activity level will be enrolled. The investigators will enroll an equal number of inactive adults and an equal number of highly active adults.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the detailed 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.
- Conditions
- Aging, Cognitive Dysfunction
- Being tested
- Brain Health Assessments
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health AssessmentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inactive | Older adults who have a sedentary or under-active lifestyle. Receives: Behavioral: Brain Health Assessments | |
| Highly Active | Older adults who have a highly active lifestyle. Receives: Behavioral: Brain Health Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of GPLD1
Plasma GPLD1 (by a blood draw) is performed.
Measured: 1 day
Secondary outcomes (4)
Physical activity level
Physical activity level assessment (by accelerometry) is performed.
Measured: 7 days
Total grey matter volume
Total grey matter volume (by structural MRI) is performed.
Measured: 1 day
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.
Measured: 1 day
Cognitive function
Cognitive function testing (using the NIH Toolbox Cognitive Battery) is performed.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Apr 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Kara L Marlatt, PhD, MPH, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645134
- Sponsor's protocol ID
- PBRC 2020-050
- Acronym
- BrainFit
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marlatt KL, Lowe AC, Sanchez-Delgado G, Beyl RA, Viverito MK, Keller JN, Carmichael OT, Ravussin E. Associations between physical activity, brain health, cognitive function, and circulating GPLD1 in healthy older (65-85 years) individuals. Geroscience. 2025 Jun;47(3):3821-3834. doi: 10.1007/s11357-024-01459-8. Epub 2025 Jan 6.
PubMed 39762691
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1
- ClinicalTrials.gov ID
- NCT04645134
- Acronym / sponsor ID
- BrainFit / PBRC 2020-050
- Conditions
- Aging, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactive | – | Behavioral: Brain Health AssessmentsOlder adults who have a sedentary or under-active lifestyle. |
| Highly Active | – | Behavioral: Brain Health AssessmentsOlder adults who have a highly active lifestyle. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Up to 28 healthy, older adults (ages 65-85 y, BMI 20-35 kg/m2) stratified by current physical activity level will be enrolled. The investigators will enroll an equal number of inactive adults and an equal number of highly active adults.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Health AssessmentsThe 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. | Behavioural | Highly Active, Inactive |
Primary outcome
Plasma concentrations of GPLD1
Time frame: 1 day
Plasma GPLD1 (by a blood draw) is performed.
4 secondary outcomes
Physical activity level
Time frame: 7 days
Total grey matter volume
Time frame: 1 day
Brain activity and function
Time frame: 1 day
Cognitive function
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 39762691Marlatt KL, Lowe AC, Sanchez-Delgado G, Beyl RA, Viverito MK, Keller JN, Carmichael OT, Ravussin E. Associations between physical activity, brain health, cognitive function, and circulating GPLD1 in healthy older (65-85 years) individuals. Geroscience. 2025 Jun;47(3):3821-3834. doi: 10.1007/s11357-024-01459-8. Epub 2025 Jan 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara L Marlatt, PhD, MPH principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Cognitive Dysfunction, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of GPLD1 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.