NCT04645134

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

November 22, 2020

Last Update Submit

November 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of GPLD1

    Plasma GPLD1 (by a blood draw) is performed.

    1 day

Secondary Outcomes (4)

  • Physical activity level

    7 days

  • Total grey matter volume

    1 day

  • Brain activity and function

    1 day

  • Cognitive function

    1 day

Study Arms (2)

Inactive

Older adults who have a sedentary or under-active lifestyle.

Behavioral: Brain Health Assessments

Highly Active

Older adults who have a highly active lifestyle.

Behavioral: Brain Health Assessments

Interventions

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 ActiveInactive

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Kara L Marlatt, PhD, MPH

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Executive Director for Clinical Science

Study Record Dates

First Submitted

November 22, 2020

First Posted

November 27, 2020

Study Start

April 1, 2021

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations