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Ketogenic Diet vs Low-Fat Diet for Alzheimer's Disease (BEAT-AD Trial)

N/A
Recruiting
Led By Suzanne Craft, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of amnestic mild cognitive impairment
Be older than 18 years old
Must not have
Current evidence or history in past year of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
Diagnosis of neurodegenerative illness (except for MCI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Summary

This trial is comparing the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from dietary changes may include gastrointestinal discomfort like constipation or diarrhea when adjusting to the new diet. The ketogenic diet might also cause temporary fatigue or headaches as the body adapts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with mild memory loss.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had a serious brain injury, lost consciousness, or been diagnosed with a major psychiatric disorder in the past year.
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I have been diagnosed with a neurodegenerative illness other than MCI.
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I do not have any major illnesses like uncontrolled high blood pressure, heart disease, severe lung, liver, or kidney disease.
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I have had a serious stroke in the past.
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I am currently taking medication for my diabetes.
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I have had epilepsy or a seizure in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cerebrospinal Fluid (CSF) Abeta42
Secondary study objectives
CSF abeta42/ptau ratio
Cerebral Blood Flow Measure with Arterial Spin Labeling (ASL) MRI
Preclinical Alzheimer Cognitive Composite (PACC)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Modified Mediterranean Ketogenic DietExperimental Treatment1 Intervention
The MMKD is a low carbohydrate/high fat diet aimed at inducing ketosis, as the experimental diet in the proposed study. Participants on the MMKD will keep their daily carbohydrate consumption below 20 grams per day throughout the 4 month intervention.The MMKD group will be supplied with extra virgin olive oil during their in person visits to use as a source of fat in their diet, and will be encouraged to eat plentiful fish, lean meats, and nutrient rich foods that meet the requirement of \<20 grams total carbohydrates per day. Participants will receive a daily multivitamin (Centrum Silver) over the course of the study and instructed to take 1 tablet each day while on the diet.
Group II: American Heart Association DietExperimental Treatment1 Intervention
The American Heart Association Diet (AHAD), is a low fat/high carbohydrate diet (\<40 grams/day) will be used as the control diet. Participants on the AHAD will be encouraged to limit their amount of fat intake to \<40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Participants will receive the same daily multivitamin supplement (Centrum Silver) over the course of the study and instructed to take 1 tablet each day while on the diet.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,587 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,883 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences
16 Previous Clinical Trials
1,947 Total Patients Enrolled

Media Library

Low-carbohydrate/High-fat Diet Clinical Trial Eligibility Overview. Trial Name: NCT03472664 — N/A
Alzheimer's Disease Research Study Groups: Modified Mediterranean Ketogenic Diet, American Heart Association Diet
Alzheimer's Disease Clinical Trial 2023: Low-carbohydrate/High-fat Diet Highlights & Side Effects. Trial Name: NCT03472664 — N/A
Low-carbohydrate/High-fat Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03472664 — N/A
~9 spots leftby Apr 2025
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