120 Participants Needed

Ketogenic Diet vs Low-Fat Diet for Alzheimer's Disease

(BEAT-AD Trial)

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Overseen ByLauren Latham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The ketogenic diet is generally considered safe for humans, but some people may experience side effects like changes in cholesterol levels, constipation, and fatigue. Long-term use could potentially affect kidney function, especially in those with existing kidney issues.12345

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, PhD | Wake Forest ...

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

I have been diagnosed with mild memory loss.
My medications have been the same for at least 4 weeks.
Able to complete baseline assessments
See 2 more

Exclusion Criteria

I haven't had a serious brain injury, lost consciousness, or been diagnosed with a major psychiatric disorder in the past year.
Sensory impairment (i.e.: visual or auditory) that would preclude the participant from participating in the protocol
I have been diagnosed with a neurodegenerative illness other than MCI.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

16 weeks
Regular clinic visits and phone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with final assessments occurring 8 weeks after diet completion.

8 weeks
Final visits at week 24

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
Trial Overview The BEAT-AD study is testing if a ketogenic low-carbohydrate diet versus a low-fat diet affects cognitive function in adults with mild cognitive impairment over 16 weeks. Participants will be randomly assigned to one of the diets and monitored for changes in brain function and biomarkers related to Alzheimer's disease.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Modified Mediterranean Ketogenic DietExperimental Treatment1 Intervention
Group II: American Heart Association DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

In a study of 75 Alzheimer's patients over 3 months, the type of diet (normal, diabetic, or texture-modified) significantly influenced weight loss, with texture-modified diets being the most common among participants.
Non-malnourished patients showed notable differences in weight loss rates based on their diet type, highlighting the importance of tailored dietary approaches for managing weight in Alzheimer's patients.
The Impact of Diet Type on Weight Loss in Patients with Alzheimer's Disease.Nakamura, T.[2021]
A modified Mediterranean-ketogenic diet (MMKD) showed promising effects in older adults at risk for Alzheimer's, leading to increased cerebrospinal fluid Aฮฒ42 levels and decreased tau, which are biomarkers associated with Alzheimer's disease.
Participants on the MMKD also experienced improved metabolic indices and increased cerebral perfusion, suggesting that this diet may help in preventing cognitive decline in at-risk individuals.
Modified ketogenic diet is associated with improved cerebrospinal fluid biomarker profile, cerebral perfusion, and cerebral ketone body uptake in older adults at risk for Alzheimer's disease: a pilot study.Neth, BJ., Mintz, A., Whitlow, C., et al.[2020]
In a randomized crossover trial involving 26 Alzheimer's disease patients, a 12-week modified ketogenic diet led to significant improvements in daily functioning and quality of life compared to a usual diet, with patients showing increased scores on the ADCS-ADL and QOL-AD assessments.
The ketogenic diet was well-tolerated, with high adherence (81% completion) and only mild adverse effects reported, indicating it is a safe dietary intervention for individuals with Alzheimer's disease.
Randomized crossover trial of a modified ketogenic diet in Alzheimer's disease.Phillips, MCL., Deprez, LM., Mortimer, GMN., et al.[2021]

Citations

The Impact of Diet Type on Weight Loss in Patients with Alzheimer's Disease. [2021]
Modified ketogenic diet is associated with improved cerebrospinal fluid biomarker profile, cerebral perfusion, and cerebral ketone body uptake in older adults at risk for Alzheimer's disease: a pilot study. [2020]
Randomized crossover trial of a modified ketogenic diet in Alzheimer's disease. [2021]
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]
MIND Diet, Common Brain Pathologies, and Cognition in Community-Dwelling Older Adults. [2021]
Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities. [2022]
Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. [2023]
Ketogenic diets for weight loss: A review of their principles, safety and efficacy. [2022]
Moderate-carbohydrate low-fat versus low-carbohydrate high-fat meal replacements for weight loss. [2013]
Low-carbohydrate ketogenic diets in body weight control: A recurrent plaguing issue of fad diets? [2021]
Efficacy and Safety of Ketone Supplementation or Ketogenic Diets for Alzheimer's Disease: A Mini Review. [2022]
The possibility of use of the ketogenic diet and medium chain triglycerides supplementation in the support therapy of Alzheimer disease. [2023]
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