TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of California, San Diego
About 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Persons, aged ≥60 years
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.
Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
Daily night fasting <12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
Disqualifiers
Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
Presenting cognitive impairment not due to AD.
Clinical diagnoses of diabetes.
Actively using insulin in the past 6 months.
Trial design
Design model
Crossover
Treatments tested in this trial
Time-restricted eating
BehavioralFasting (abstinence from calorie-containing food or drink) during 14 h at night, with no caloric consumption after 8 pm to align with circadian rhythms
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Delayed-Start InterventionActive comparator 1 intervention
Group B: InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.
Test the feasibility of a Time-restricted eating intervention in patients with MCI or AD by quantification the number of days during the intervention period when the particpants reached the goal intervention fasting time of 14 h, b) increased fasting of \>12 h and \<14 h.
Time frame
3 and 6 monthsSecondary outcomes
1
Effects of TRE on activity rhythms measured as steps/day using an accelerometer
The investigators will measure the participants' 24-hour activity rhythms using an actigraph unit. The investigators will calculate interday stability and intraday variability of activity rhythms, which have been reported as sensitive in studies on aging and AD cohorts. Interday stability will indicate the stability of rhythms across several days. Intraday variability will indicate the fragmentation of rhythms.
Time frame
baseline, 3 and 6 months2
Effects of TRE on skin temperature rhythms measured in F using a smart sensor.
The investigators will measure the participants' 24-hour temperature rhythms using a smart sensor. The investigators will calculate interday stability and intraday variability of skin temperature as a circadian output.
Time frame
baseline, 3 and 6 months3
Effects of TRE on sleep quantity (as hours/night) using a smart sensor.
The investigators will determine changes in sleep duration during the study as recorded by a smart sensor and accessed via the Fitabase.
Time frame
Baseline, 3 and 6 months4
Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor.
The investigators will determine whether the overall sleep efficiency changes based on the sleep score calculated based on metrics collected with the accelerometer watch. The overall sleep score is a sum of the individual scores in sleep duration, sleep quality, and restoration, with a maximum of 100. Sleep score tiers are: Excellent: 90-100; Good: 80-89; Fair: 60-79; Poor: Less than 60.
Time frame
baseline, 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov