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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
BEAT-AD Trial 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.Check my eligibility
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.See study design
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.
BEAT-AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild memory loss.
BEAT-AD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cerebrospinal Fluid (CSF) Abeta42
Secondary outcome measures
CSF abeta42/ptau ratio
Cerebral Blood Flow Measure with Arterial Spin Labeling (ASL) MRI
Preclinical Alzheimer Cognitive Composite (PACC)
BEAT-AD 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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,147 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,673 Previous Clinical Trials
28,020,723 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences
16 Previous Clinical Trials
1,947 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with mild memory loss.My medications have been the same for at least 4 weeks.I haven't had a serious brain injury, lost consciousness, or been diagnosed with a major psychiatric disorder in the past year.I have been diagnosed with a neurodegenerative illness other than MCI.I do not have any major illnesses like uncontrolled high blood pressure, heart disease, severe lung, liver, or kidney disease.I have had a serious stroke in the past.I have cancer, but it's either stable prostate cancer or a non-melanoma skin cancer.I am currently taking medication for my diabetes.I have had epilepsy or a seizure in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Modified Mediterranean Ketogenic Diet
- Group 2: American Heart Association Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I a suitable candidate to partake in this investigation?
"Alzheimer's disease sufferers aged between 55 and 85 years old can enrol in this clinical trial, providing they meet the following criteria: a reliable source to give corroborating information regarding their medical condition, diagnosis of amnestic mild cognitive impairment (MCI), medications used must be stable for 4 weeks prior to screening visit as approved by treating physician, able to complete baseline assessments."
Answered by AI
How many participants has this experiment recruited thus far?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial is presently seeking volunteers, having first been posted on July 16th 2018 and last updated on May 31st 2022. The study requires the recruitment of 120 patients at 1 site."
Answered by AI
Is the age range of participants in this experiment restricted to individuals under 60 years old?
"According to the study's participant criteria, individuals aged 55 or above and 85 or below can seek enrollment in this clinical trial."
Answered by AI
Is enrollment for this research study still open?
"Affirmative. Clinicaltrials.gov showcases that this trial, which was initially uploaded on July 16th 2018, is actively seeking participants at the moment. The research team requires 120 individuals from a single clinical site to join their study."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
North Carolina
What site did they apply to?
Wake Forest Baptist Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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