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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met