- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645134
Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1 (BrainFit)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Inactive
Older adults who have a sedentary or under-active lifestyle.
|
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.
|
|
Highly Active
Older adults who have a highly active lifestyle.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma concentrations of GPLD1
Time Frame: 1 day
|
Plasma GPLD1 (by a blood draw) is performed.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity level
Time Frame: 7 days
|
Physical activity level assessment (by accelerometry) is performed.
|
7 days
|
|
Total grey matter volume
Time Frame: 1 day
|
Total grey matter volume (by structural MRI) is performed.
|
1 day
|
|
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.
|
1 day
|
|
Cognitive function
Time Frame: 1 day
|
Cognitive function testing (using the NIH Toolbox Cognitive Battery) is performed.
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2020-050
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Dysfunction
-
Maria PaçoEnrolling by invitationDietary Supplements | Cognitive Dysfunction, Cognitive DisorderPortugal
-
Universidad Autónoma del Estado de HidalgoEnrolling by invitationCognitive Dysfunction ( MMSE < 24 )Mexico
-
Mu Dong LiangNot yet recruitingPostoperative Cognitive Dysfunction(POCD)
-
Xijing HospitalFirst Affiliated Hospital Xi'an Jiaotong University; Shanghai 10th People's... and other collaboratorsTerminatedPost Operative Cognitive DysfunctionChina
-
Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA)CompletedPost Operative Cognitive DysfunctionUnited States
-
Loma Linda UniversityCompleted1. Postoperative Cognitive DysfunctionUnited States
-
Shanghai Ninth People's Hospital Affiliated to...RecruitingPOCD - Postoperative Cognitive DysfunctionChina
-
HealthPartners InstituteCompletedPost Operative Cognitive DysfunctionUnited States
-
Burcu Ozalp HorsanaliCompletedPost Operative Cognitive Dysfunction
-
Minia UniversityRecruiting
Clinical Trials on Brain Health Assessments
-
Institut National de la Santé Et de la Recherche...University College, LondonCompletedHuntington Disease | White Matter AlterationsFrance
-
Imperial College LondonRecruitingStroke | Cerebrovascular Disorders | Cognitive Impairment | Dementia, Vascular | Small Vessel Cerebrovascular Disease | Stroke (CVA) or TIAUnited Kingdom
-
Father Flanagan's Boys' HomeRecruiting
-
Turku University HospitalGöteborg University; University of Turku; University of Cambridge; Örebro University... and other collaboratorsNot yet recruiting
-
University of PennsylvaniaRecruiting
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Disease CongenitalUnited States
-
University of PennsylvaniaRecruitingTauopathiesUnited States
-
BaycrestCompletedDementia | Mild Cognitive Impairment | Dementia Prevention | Subjective Cognitive Impairment | Pre-dementiaCanada
-
Massachusetts General HospitalNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingConsciousness DisordersUnited States
-
West China HospitalRigshospitalet, Denmark; St Thomas' Hospital, LondonNot yet recruitingBrain Diseases | Aortic Valve Stenosis