NCT05218018

Brief Summary

The 'Western diet' characterized by high fat feeding (HFF) is a risk factor for Alzheimer's disease (AD); however, little is known about mechanisms. Paradoxically, individuals who carry the AD risk gene APOE E4 cognitively improve after HFF and show different metabolic responses to fat intake. These responses include a more pronounced drop in systolic blood pressure and a decrease in cerebrospinal fluid glucose and lactate levels. This proposal will further examine the brain metabolic response to HFF using non-invasive imaging. Cerebral blood flow (CBF) as assessed by functional MRI is increasingly utilized to investigate brain function, given that CBF is tightly coupled to brain metabolism. Acute changes in CBF have been described in response to carbohydrate ingestion in regions important for learning and memory; however, no one has yet assessed CBF response to lipid. Here investigators propose to characterize CBF changes to a high fat drink in older adults. This study will include a time course assessment as well as analyses of global and regional change in CBF. These data would serve as feasibility pilot data for an R01 application which would include cognitive and peripheral metabolic data. These types of studies will provide a clearer picture of acute brain metabolic response to HFF in older adults, including the effects of APOE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

December 20, 2021

Results QC Date

November 20, 2022

Last Update Submit

January 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cerebral Blood Flow Global

    Change from Baseline in Cerebral Blood Flow Global at 2 Hours

    Value at 2 hours minus value at baseline

  • Cerebral Blood Flow Change Scores

    Change from Baseline in Cerebral Blood Flow Global at 1, 2 and 3 Hours Post Lipid Drink

    1 hour minus baseline, 2 hours minus baseline, and 3 hours minus baseline

Study Arms (1)

Intervention

OTHER

Only one arm of study

Dietary Supplement: Lipid drink

Interventions

Lipid drinkDIETARY_SUPPLEMENT

100 mls of heavy cream

Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously completed the Meal and Memory study
  • Age 55 and older
  • Able to read and understand English
  • Able to give informed consent
  • Able to undergo MRI and ingest dairy products

You may not qualify if:

  • Did not screen in the Meal and Memory study
  • Allergic to or not able to ingest study ingredient (dairy)
  • Metal in body or otherwise unable to lay still for an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Angela Hanson
Organization
University of Washington

Study Officials

  • Angela J Hanson, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants undergo the same intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Medicine

Study Record Dates

First Submitted

December 20, 2021

First Posted

February 1, 2022

Study Start

March 1, 2020

Primary Completion

January 13, 2022

Study Completion

January 13, 2022

Last Updated

February 8, 2023

Results First Posted

February 8, 2023

Record last verified: 2023-01

Locations