Time Restricted Eating in Alzheimer's Disease
ConditionMild Cognitive Impairment (MCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-89
SponsorSt. Joseph's Hospital and Medical Center, Phoenix
About this trial
This pilot and feasibility study will enable the research team to determine the feasibility of implementing a time-restricted eating regimen among adults with mild cognitive impairment (MCI) and the impact of time-restricted eating on cognitive performance and biomarkers of metabolic health in this population. Study staff will execute the specific aims using a pre-post, non-randomized study design in which all participants receive the intervention. The intervention is a 16/8 time-restricted eating regimen characterized by fasting for 16 hours and eating within an 8-hour window on 5 days per week for 3 months. Assessments will be performed at baseline and after the 3-month time-restricted eating intervention with the following outcome measures.
Outcome measures for feasibility include participant recruitment, retention and metrics of acceptability, safety, and adherence to the intervention. Outcome measures for cognitive performance and metabolic health include neuropsychological tests, blood biomarkers, and surveys of psychological well-being.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female outpatients 55-89 years of age.
Meet Mayo Clinic Criteria for MCI.
If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose for at least the preceding 3 months.
A body mass index ≥18.5 and <40.0 kg/m2.
Disqualifiers
Diabetes mellitus that requires insulin treatment or is not well managed.
An eating disorder.
A contraindication to time-restricted eating.
Daily eating window <11 hours/day on ≥3 days/week.
Trial design
Design model
Single group
Treatments tested in this trial
Dietary Intervention
BehavioralParticipants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment (Anton, Lee et al. 2019, Lee, Sypniewski et al. 2020). The intervention will be implemented through individual and group sessions with participants and will involve extensive education, coaching, guidance, and support throughout the 3-month intervention. Educational materials on lifestyle factors including physical activity will be provided to each participant. We will be also be collecting data on physical activity and sedentary behavior. These data will be co-variates when we conduct the statistical analysis.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: InterventionalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance will be estimated using HOMA-IR.
Time frame
Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).2
Average number of days per week of time-restricted eating
Feasibility will be assessed based on the average number of days per week that participants eat within the 8-hour eating window. The intervention goal is 5 or more days per week.
Time frame
The eating window is assessed daily throughout the 3-month intervention.Secondary outcomes
1
Physical Activity and Sedentary Behavior Questionnaire Score
The Physical Activity and Sedentary Behavior Questionnaire will assess active time and time spent on exercise (PASB-Q; English Version) (Sattler et al., 2020)
Time frame
Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).2
Memory as measured by the Comprehensive TrailMaking Test (CTMT)
The Comprehensive Trail Making Test (CTMT) is a measure of organized visual search, attention, set shifting and divided attention (Reynolds 2002).
Time frame
Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).3
Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)
The Mini Mental State Examination (MMSE) is used extensively in clinical and research settings to systematically measure and assess mental status. It is an 11- question measure that tests five areas of cognitive function: orientation, registration, attention, and calculation, recall, and language (Folstein et al., 1975).
Time frame
Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).4
Verbal Memory as Measured by the Auditory VerbalLearning Test (AVLT)
The Auditory Verbal Learning Test (AVLT) evaluates verbal memory by presenting a 15- word list five times followed by attempted recall. This is followed by a second 15-word recall interference list, followed by recall of the original list (Rey A. 1964).
Time frame
Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).Sponsors and contacts
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St. Joseph's Hospital and Medical Center, Phoenix
Lead sponsor
Arizona State University
Collaborator
Karlsruhe Institute of Technology
Collaborator
Mayo Clinic
Collaborator
Source ClinicalTrials.gov