TREAD: Time Restricted Eating Intervention for Alzheimer's Disease

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06548191
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Time-restricted eating — BEHAVIORAL
    Fasting (abstinence from calorie-containing food or drink) during 14 h at night, with no caloric consumption after 8 pm to align with circadian rhythms

Study Details

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

Key Dates

Start date
Apr 23, 2025
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Delayed-Start Intervention
    Participants will continue their regular eating schedule (nightly fasting for less than 12 h) during the first 3 months and start time-restricted eating intervention ( 14 h of nightly fasting) for the next 3 months.
  • Active Comparator: Intervention
    Participants will follow the time-restricted regimen (14 h of nightly fasting) for 6 months.

Primary Outcome Measure

Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h. [ Time Frame: 3 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shiley Marcos Alzheimer's Disease CenterSan DiegoCalifornia92093
Paula Desplats
[email protected]
Paula Desplats, PhD (PRINCIPAL_INVESTIGATOR)
Gabriel Leger, MD (SUB_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Shiley Marcos Alzheimer's Disease Center· San Diego, CA

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