Fasting-Mimicking diet tested to protect aging brains
NCT ID NCT06682767
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This study tests whether a special low-calorie, plant-based diet taken for 5 days each month can safely improve blood flow to the brain in middle-aged adults who carry the APOE4 gene, which raises Alzheimer's risk. Forty participants aged 45-65 will be randomly assigned to either the fasting-mimicking diet or standard dietary guidance for six months. The main goals are to check safety and see if the diet affects brain blood flow measured by MRI.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fasting-mimicking diet (FMD)
- What this could lead to
- If it works, this could point toward a simple dietary approach to support brain health and potentially lower Alzheimer's risk in people with the APOE4 gene.
- What could go wrong
- This is a very small, early feasibility study with only 40 participants. It is not designed to prove the diet prevents or treats Alzheimer's, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 45-65 years at screening 4. Carrier of at least one copy of the APOE e4 allele 5. BMI 20-39kg/m2 (inclusive) at screening 6. On a stable medication regimen for at least 3 months. 7. For females: Post-menopausal status or use of highly effective contraception. Exclusion Criteria: * Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation\* (\*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial); * Significant depression (PHQ-9\>9) or generalized anxiety (GAD-7\>9) * Diagnosis of a significant neurological condition such as multiple sclerosis, epilepsy, Parkinson's disease, major stroke * Contraindications to MRI such as claustrophobia, cardiac pacemaker, etc. * Current adherence or adherence within the past 3 months to a specialized diet (e.g. ketogenic, paleo, intermittent fasting, raw food, vegan) * Food allergies (e.g. dairy, eggs, fish/shellfish, peanuts, tree nuts, soy, wheat, sesame, corn) * Diagnosis of mild cognitive impairment or dementia; use of an FDA-approved medication for Alzheimer's disease; MoCA\<23 * Diabetes (hbA1c \>6.5%) or anti-diabetic medications * History of gastric bypass; * Inflammatory bowel disease * Small or large bowel resection * Subjects with recent weight loss (\>5%), use of weight loss medication, participated in a weight loss program in the past 3 months * Use of immune suppression drugs; * Contraindication for study foods (special food needs and allergy); * Women who are pregnant, lactating, or trying to conceive * Women who are on hormone replacement therapy * Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men) * Current smoker or tobacco use within 3 months. * Active malignant cancer or history of malignancy within the last 1 yea1s (except non-melanoma skin cancer) * Serious psychiatric disorders such as schizophrenia, bipolar disorder, eating disorders * Persons with allergy to animal dander or animal-instigated asthma * Required use of drugs that affect cytochrome P450 3A4 or alter cerebral blood flow (see Appendix 1 for tables of excluded medications) * Current or chronic liver, kidney, cardiac, or pulmonary diseases * Untreated hypertriglyceridemia (fasting triglycerides \> 300 mg/dl) * Poorly controlled blood pressure (systolic BP \> 160 or diastolic BP \> 100 mmHg
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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