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Dietary Supplement

High-Fat Diet for Alzheimer's Disease

N/A
Recruiting
Led By Angela J Hanson, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Strive for equal numbers of men and women; women need to be post-menopausal for at least 1 year or medical equivalent (hysterectomy)
Able to cognitively and physically give informed consent
Must not have
Major digestive disorders: Disorders which would affect fat tolerance and absorption will be excluded including inflammatory bowel disease, gastric bypass or banding, or small intestine resection. Also excluded are allergies or major intolerance to milk or dairy products.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours post-drink ingestion
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how high-fat diets affect Alzheimer's risk in people who carry the AD risk gene.

Who is the study for?
This trial is for individuals aged 55 or older, both with and without the Alzheimer's risk gene E4. Participants must be post-menopausal women or men, able to consent, undergo an MRI, and ingest dairy. Exclusions include those on diabetes/hypertension medication (unless they can stop safely), with psychiatric disorders affecting study outcomes, metal implants incompatible with MRI, significant lipid abnormalities requiring medication (unless willing to stop), diagnosed dementia or severe cognitive impairment.
What is being tested?
The study investigates how a high-fat diet using heavy cream affects brain blood flow in people at risk of Alzheimer's disease. It focuses on differences between carriers and non-carriers of the APOE E4 gene by measuring cerebral blood flow through arterial spin labeling during an MRI scan.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from ingesting heavy cream may include gastrointestinal discomfort such as bloating or diarrhea especially in lactose intolerant individuals; however these are general assumptions as specific side effects related to the trial intervention are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who is post-menopausal for at least 1 year or have had a hysterectomy.
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I am mentally and physically capable of understanding and agreeing to the study.
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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have major digestive disorders or a severe allergy to milk/dairy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours post-drink ingestion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours post-drink ingestion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in global cerebral blood flow between baseline and 2 hours post lipid ingestion (Change CBF)
Secondary study objectives
Change in regional CBF
Fluid Cognitive Composite Standard Score
Other study objectives
Change in global cerebral blood flow as correlated with exploratory factors
Change in regional cerebral blood flow as correlated with exploratory factors

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
All participants undergo the same intervention: Drinking heavy cream and undergoing MRI.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,292 Total Patients Enrolled
21 Trials studying Dementia
6,936 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,242 Total Patients Enrolled
292 Trials studying Dementia
23,634,389 Patients Enrolled for Dementia
Angela J Hanson, MDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

Heavy Cream (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04692441 — N/A
Dementia Research Study Groups: Intervention
Dementia Clinical Trial 2023: Heavy Cream Highlights & Side Effects. Trial Name: NCT04692441 — N/A
Heavy Cream (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692441 — N/A
~13 spots leftby Jun 2025
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