High-Fat Diet for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Must not be taking: Diabetes meds, Hypertension meds, Statins, Dementia meds
Disqualifiers: Diabetes, Hypertension, Dementia, Psychiatric disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?High fat feeding (HFF) increases the risk of Alzheimer's disease (AD) but individuals who carry the AD risk gene E4 paradoxically improve after acute HFF. The investigators propose to further study this phenomenon with a clinical study to assess cerebral blood flow which can be measured by a technique called arterial spin labeling (ASL) on an MRI and is tightly related to brain metabolism.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications. If you have hypertension, you must stop your medication for 2 weeks before the MRI visit, if safe. For significant lipid abnormalities, you need to stop medications like statins 4 weeks before the screening visit, unless they are for preventing heart attack or stroke.
What data supports the effectiveness of the treatment Heavy Cream for Alzheimer's Disease?
Research suggests that a high intake of certain fatty acids, like those found in heavy cream, may be linked to a lower risk of Alzheimer's disease.
12345Is a high-fat diet safe for humans?
Some studies suggest that high intake of saturated and trans fats may increase the risk of Alzheimer's disease and other cognitive disorders, but the evidence is mixed and not all studies agree. There is no specific safety data on high-fat diets for Alzheimer's, but caution is advised due to potential links with cognitive decline.
16789How does the high-fat diet treatment using heavy cream differ from other treatments for Alzheimer's disease?
The high-fat diet treatment using heavy cream is unique because it focuses on dietary changes rather than supplements or medications, and it may have different effects on memory, especially in individuals with a specific genetic risk factor (APOE ε4). This approach contrasts with omega-3 fatty acid treatments, which are derived from fish oil and target different aspects of Alzheimer's disease.
1011121314Eligibility Criteria
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.Inclusion Criteria
I am a woman who is post-menopausal for at least 1 year or have had a hysterectomy.
Able to read and understand English
My genetic test shows whether I have the APOE E4 gene.
+3 more
Exclusion 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.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Study Visit
Participants undergo MRI and oral triglyceride tolerance test (OTTT) after fasting
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the study visit
4 weeks
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
All participants undergo the same intervention: Drinking heavy cream and undergoing MRI.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Washington Medical CenterSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Dietary fatty acids and risk of Alzheimer's disease and related dementias: Observations from the Washington Heights-Hamilton Heights-Inwood Columbia Aging Project (WHICAP). [2021]High dietary intake of long chain, polyunsaturated fatty acids is associated with lower Alzheimer's disease (AD) risk.
The Impact of Diet Type on Weight Loss in Patients with Alzheimer's Disease. [2021]To compare differences in weight loss in patients with Alzheimer's disease on normal, diabetic, or texture-modified diets.
Nutritional and cognitive relationships and long-term mortality in patients with various dementia disorders. [2006]Subjects with dementia are at risk for protein-energy malnutrition.
Omega-3 fatty acid supplementation effects on weight and appetite in patients with Alzheimer's disease: the omega-3 Alzheimer's disease study. [2015]To study the effects of omega (Omega)-3 fatty acid (FA) supplements on weight and appetite in patients with mild to moderate Alzheimer's disease (AD) in relation to inflammatory biomarkers and apolipoprotein E epsilon4 (APOEepsilon4).
Effect of oral administration of a whole formula diet on nutritional and cognitive status in patients with Alzheimer's disease. [2006]To evaluate the effect of a whole formula diet on nutritional and cognitive status in Alzheimer's disease patients.
Saturated and trans fats and dementia: a systematic review. [2018]Cognitive disorders of later life are potentially devastating. To estimate the relationship between saturated and trans fat intake and risk of cognitive disorders. PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for studies reporting saturated or trans fat intake and incident dementia, Alzheimer's disease (AD), or mild cognitive impairment (MCI) or cognitive decline. Only observational studies met the inclusion criteria: 4 for AD or other dementias, 4 for MCI, and 4 for cognitive decline. Saturated fat intake was positively associated with AD risk in 3 of 4 studies, whereas the fourth suggested an inverse relationship. Saturated fat intake was also positively associated with total dementia in 1 of 2 studies, with MCI in 1 of 4 studies, and with cognitive decline in 2 of 4 studies. Relationships between trans fat intake and dementia were examined in 3 reports with mixed results. Several, although not all, prospective studies indicate relationships between saturated and trans fat intake and risk of cognitive disorders.
A ketogenic diet reduces amyloid beta 40 and 42 in a mouse model of Alzheimer's disease. [2020]Alzheimer's disease (AD) is a progressive neurodegenerative disorder that primarily strikes the elderly. Studies in both humans and animal models have linked the consumption of cholesterol and saturated fats with amyloid-beta (Abeta) deposition and development of AD. Yet, these studies did not examine high fat diets in combination with reduced carbohydrate intake. Here we tested the effect of a high saturated fat/low carbohydrate diet on a transgenic mouse model of AD.
Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial. [2021]Observational data have suggested that high dietary intake of saturated fat and low intake of vegetables may be associated with increased risk of Alzheimer disease.
Dietary fat composition and dementia risk. [2021]This is a qualitative review of the evidence linking dietary fat composition to the risk of developing dementia. The review considers laboratory and animal studies that identify underlying mechanisms as well as prospective epidemiologic studies linking biochemical or dietary fatty acids to cognitive decline or incident dementia. Several lines of evidence provide support for the hypothesis that high saturated or trans fatty acids increase the risk of dementia and high polyunsaturated or monounsaturated fatty acids decrease risk. Dietary fat composition is an important factor in blood-brain barrier function and the blood cholesterol profile. Cholesterol and blood-brain barrier function are involved in the neuropathology of Alzheimer's disease, and the primary genetic risk factor for Alzheimer's disease, apolipoprotein E-ε4, is involved in cholesterol transport. The epidemiologic literature is seemingly inconsistent on this topic, but many studies are difficult to interpret because of analytical techniques that ignored negative confounding by other fatty acids, which likely resulted in null findings. The studies that appropriately adjust for confounding by other fats support the dietary fat composition hypothesis.
High-Fat-Diet Intake Enhances Cerebral Amyloid Angiopathy and Cognitive Impairment in a Mouse Model of Alzheimer's Disease, Independently of Metabolic Disorders. [2022]The high-fat Western diet is postulated to be associated with the onset and progression of Alzheimer's disease (AD). However, the role of high-fat-diet consumption in AD pathology is unknown. This study was undertaken to examine the role of high-fat-diet intake in AD.
Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial. [2022]Epidemiologic and animal studies have suggested that dietary fish or fish oil rich in omega-3 fatty acids, for example, docosahexaenoic acid and eicosapentaenoic acid, may prevent Alzheimer disease (AD).
Omega-3 supplementation in mild to moderate Alzheimer's disease: effects on neuropsychiatric symptoms. [2018]Epidemiological and animal studies have suggested that dietary fish or fish oil rich in omega-3 fatty acids (omega3), docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), may have effects in psychiatric and behavioral symptoms in Alzheimer's disease (AD). An association with APOEomega4 carriers and neuropsychiatric symptoms in AD has also been suggested.
Cerebrospinal fluid lipidomics: effects of an intravenous triglyceride infusion and apoE status. [2023]High-fat diets increase risk for Alzheimer's disease, but individuals with the risk gene APOE ε4 (E4) paradoxically have improved memory soon after high fat feeding. Little is known about how dietary lipids affect CNS lipids, especially in older adults.
Fish consumption and omega-3 fatty acid supplementation for prevention or treatment of cognitive decline, dementia or Alzheimer's disease in older adults - any news? [2018]Twenty years of research indicates that fish and n-3 fatty acids (FAs), for example docosahexaenoic acid, may attenuate cognitive decline including Alzheimer's disease in older people. This review concerns reports during 2015-2016 in humans.