Ketogenic Diet vs Low-Fat Diet for Alzheimer's Disease
(BEAT-AD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids.The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study.Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been stable on your medications for at least 4 weeks before starting the study. It's best to discuss your specific medications with the study physician.
Is the ketogenic diet safe for humans?
How is the ketogenic diet treatment different from other treatments for Alzheimer's disease?
The ketogenic diet is unique because it provides an alternative fuel for the brain, using ketone bodies instead of glucose, which may help reduce neuroinflammation and improve brain metabolism in Alzheimer's patients. Unlike other treatments, it focuses on dietary changes to potentially slow cognitive decline and improve Alzheimer's biomarkers.678910
What data supports the effectiveness of the ketogenic diet treatment for Alzheimer's disease?
Research suggests that a modified ketogenic diet may improve brain function in older adults at risk for Alzheimer's by providing an alternative energy source for the brain, improving certain biomarkers, and enhancing memory performance. Additionally, fish and omega-3 fatty acids, which are components of some ketogenic diets, have been linked to slower cognitive decline in older adults.67101112
Who Is on the Research Team?
Suzanne Craft
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Adults with mild cognitive impairment who are stable medically and on medications can join this study. They need an informant to provide additional information about them. People with significant sensory impairments, liver issues, other neurodegenerative diseases besides MCI, MRI contraindications, active cancer (except certain types), recent seizures or strokes, major psychiatric disorders, diabetes needing medication, or serious illnesses cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants follow either a ketogenic low-carbohydrate diet or a low-fat diet for 16 weeks, with personalized nutritional guidance and compliance assessment by a dietitian.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with final assessments occurring 8 weeks after diet completion.
Diet Education
Participants have the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet after the study.
What Are the Treatments Tested in This Trial?
Interventions
- Low-carbohydrate/High-fat Diet
- Low-fat/High-carbohydrate Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Institute on Aging (NIA)
Collaborator