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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours post-drink ingestion
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman who is post-menopausal for at least 1 year or have had a hysterectomy.
Select...
I am mentally and physically capable of understanding and agreeing to the study.
Select...
I am 55 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours post-drink ingestion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours post-drink ingestion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in global cerebral blood flow between baseline and 2 hours post lipid ingestion (Change CBF)
Secondary outcome measures
Change in regional CBF
Fluid Cognitive Composite Standard Score
Other outcome measures
Change in global cerebral blood flow as correlated with exploratory factors
Change in regional cerebral blood flow as correlated with exploratory factors
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
All participants undergo the same intervention: Drinking heavy cream and undergoing MRI.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,676 Total Patients Enrolled
20 Trials studying Dementia
6,839 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,835 Total Patients Enrolled
268 Trials studying Dementia
23,627,516 Patients Enrolled for Dementia
Angela J Hanson, MDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
108 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have severe lipid problems and can stop certain medications before the trial.I have diabetes that needs medication, but diet control or past gestational diabetes is okay.I can safely stop my hypertension medication for 2 weeks before the MRI.I do not have dementia, severe head injuries, recent stroke, or advanced Parkinson's disease.If you have untreated severe depression, psychosis, mania, or if you are unkind or uncooperative with the staff, you cannot participate. However, if you are getting help for these conditions, you may be able to join the study. If you have an active alcohol or drug abuse problem, you cannot participate.I do not have major digestive disorders or a severe allergy to milk/dairy.I do not have severe illnesses that would make study participation difficult.I am a woman who is post-menopausal for at least 1 year or have had a hysterectomy.My genetic test shows whether I have the APOE E4 gene.I am mentally and physically capable of understanding and agreeing to the study.You have metal in your body that is not safe for MRI scans, or you have a condition that makes it difficult for you to lie still for a long time.I am 55 years old or older.You can have an MRI and drink milk.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit for people participating in this investigation?
"Yes, according to clinicaltrials.gov this trial is currently open for enrollment and was first posted on May 1st 2021. The most current update of the study occurred November 10th 2022 and 90 people are being sought at a single medical facility."
Answered by AI
Are participants still being enrolled for this clinical research?
"Confirmatively, clinicaltrials.gov indicates that recruitment is still ongoing for this research project which was first put up on May 1st 2021 and recently modified on November 10th 2022. This venture requires 90 volunteers to take part from a single location."
Answered by AI
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