Recruiting
Phase 1

Time Restricted Eating

Sponsor:

UCLA

Code:

NCT06548191

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Time-restricted eating

Study Details

Brief summary:

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

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Alzheimer's Disease

Study ID

NCT06548191

Start date

Apr 23, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study.

Inclusion criteria

1. Persons, aged ≥60 years
2. In good general health as evidenced by medical history or diagnosed with clinical diagnosis of MCI/AD: meeting research consensus criteria for probable MCI or dementia due to AD, requiring positive amyloid biomarkers in brain or cerebrospinal fluid (CSF) obtained at their regular point of care or study referral no longer than 3 months prior to screening.
3. Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
4. Daily night fasting <12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
5. For cognitively normal living partners in the dyads group, scores >26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.

Exclusion Criteria:

1. Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
2. Presenting cognitive impairment not due to AD.
3. Clinical diagnoses of diabetes.
4. Actively using insulin in the past 6 months.
5. Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
6. Currently taking any medication known to affect appetite, inlcuding but not limited to GLP-1 agonists.
7. Any history of disordered eating, including difficulty swallowing and refusal to eat.
8. Currently engaged in shift work.
9. In treatment with another investigational drug.
10. Body Mass Index (BMI) <20. or >35

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Time-restricted eating

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

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 and Locations

Central contacts

Paula Desplats, PhD

858-534-4839pdesplat@health.ucsd.edu

Olivia Ott, M.S.

TREAD@health.ucsd.edu

Locations

Shiley Marcos Alzheimer's Disease Center

Recruiting

San Diego, California, United States, 92093

Contacts

Paula Desplats

TREAD@health.ucsd.edu

Principal Investigator:

Paula Desplats, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Time-Restricted Eating
  • Intermittent Fasting
  • Prolonged Nightly Fasting
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Circadian Rhythms
  • Cognition
  • Neuropathology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-05-26.