Time-Restricted Eating for Alzheimer's Disease
(TREAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if restricting the time of eating to allow for prolonged fasting at night may reduce sleep disturbances, cognitive decay, and pathology in patients diagnosed with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). It will also learn about the feasibility of practicing 14 h of nightly fasting in this group of older adults. The main questions it aims to answer are:* Does prolonged nightly fasting of 14 h can reduce markers of AD pathology and aging and reduce cognitive and sleep alterations in MCI and AD patients?* Can patients with MCI and early /moderate AD sustain time-restricted eating for 3 to 6 months? Researchers will compare participants who fast for 14 h per night during 3 months to those who fast for less than 12 h/night. Researchers will also compare participants that fast for 3 months to those who fast during 6 months, to determine the effective duration of the intervention. Finally, researchers will evaluate whether following the time-restricted eating diet alongside a partner actively following the same diet, will increase adherence to the protocol compared to subjects that fast alone.Participants will:* Fast for 14 h a night (stop eating at 8 pm and start eating the following morning at 10 am) for 3 or 6 months* Visit the clinic three times (at the beginning of the study, 6 and 12 months later)* Provide blood samples and take a cognitive test during clinic visits* Keep a diary (or use an app on a smart phone) to record time of eating* Wear an activity tracker watch
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have started a new medication for MCI/AD or changed doses in the last three months, or if you are taking medications that affect appetite.
Is time-restricted eating safe for humans?
Time-restricted eating (TRE) has been studied in both animals and humans, showing potential benefits for brain health and metabolism. While animal studies suggest positive effects, human studies have varied results, and more research is needed to fully understand its safety and effects in people.12345
How is time-restricted eating different from other treatments for Alzheimer's disease?
Time-restricted eating (TRE) is unique because it focuses on aligning eating patterns with the body's natural circadian rhythms, which are often disrupted in Alzheimer's disease. Unlike traditional treatments that may target specific symptoms or use medications, TRE aims to improve overall brain health by reducing amyloid deposition and enhancing memory through a structured eating schedule without changing calorie intake.12367
What data supports the effectiveness of the treatment Time-Restricted Eating for Alzheimer's Disease?
Who Is on the Research Team?
Paula Desplats, PhD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for adults with Mild Cognitive Impairment or early to moderate Alzheimer's Disease who are interested in trying a time-restricted eating pattern. Participants will need to fast for 14 hours nightly and be willing to visit the clinic three times, provide blood samples, take cognitive tests, and track their eating habits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants follow a time-restricted eating regimen with 14 hours of nightly fasting for 3 or 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Delayed-Start Intervention
Participants continue their regular eating schedule for 3 months, then start the time-restricted eating intervention for the next 3 months
What Are the Treatments Tested in This Trial?
Interventions
- Time Restricted Eating
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
National Institute on Aging (NIA)
Collaborator