Clinical trial NCT06429124: Time Restricted Eating in Alzheimer's Disease
Official title: Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Alzheimer&#39;s Disease
Mild Cognitive Impairment
Intermittent Fasting
Nutritional Strategies
Time Restricted Eating
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Karlsruhe Institute of Technology
name: Mayo Clinic
First posted: 2024-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will execute the specific aims using a pre-post non-randomized study design in which all participants receive the intervention. Outcome assessments for specific aim 2 will include neuropsychological tests, blood biomarkers, and psychological well-being measured at baseline and after 3 months of intervention.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The goal of this pilot study on time restricted eating regimens in the mild cognitive impairment (MCI) patient population will be to determine the feasibility of implementing the intervention and impact of time-restricted eating on cognitive performance and biomarkers of metabolic health. Researchers at the Barrow Neurological Institute, Alzheimer\&amp;#39;s Disease Program in collaboration with the Arizona State University College of Health Solutions will execute the specific aims using a pre-post non-randomized study design in which all participants receive the intervention. Outcome assessments for specific aim 2 will include neuropsychological tests, blood biomarkers, and psychological well-being measured at baseline and after 3 months of intervention.

Participants 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. Primary outcomes will include participant recruitment, retention, acceptability, safety, and adherence to the 16 hours of fasting and 8-hour eating window. Researchers hypothesize that participants who follow a time-restricted eating pattern will have improvements in attention, working memory and semantic fluency domains. Study staff hypothesize that there will be improvements or trends toward improvements in inflammatory and cardiometabolic biomarkers (i.e., interleukin-6, tumor necrosis factor alpha, C-reactive protein, insulin, hemoglobin A1c, and lipids).

The results of this project will provide critical preliminary data for a longer-term, large-scale, randomized controlled trial of time-restricted eating on cognitive trajectory among adults with MCI. The novel findings from the proposed project and future studies will contribute significantly to the body of knowledge that will advance the field, with the ultimate goal of preventing or delaying the progression of MCI to dementia.

Eligibility criteria: Inclusion Criteria:

1. Male or Female outpatients 55-89 years of age.
2. Meet Mayo Clinic Criteria for MCI.
3. 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.
4. A body mass index ≥18.5 and \<40.0 kg/m2.
5. Access to the internet through computer or smartphone.
6. Must have a collateral informant/study partner(e.g. spouse or adult child) who has significant direct contact with the patient and who is willing to accompany the patient to specified clinic visits and be available for telephone visits/Interviews.
7. An education level \> 8 years.
8. A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
9. Vision and hearing must be sufficient to comply with study procedures.

Exclusion Criteria:

1. Diabetes mellitus that requires insulin treatment or is not well managed.
2. An eating disorder.
3. A contraindication to time-restricted eating.
4. Daily eating window \<11 hours/day on ≥3 days/week.
5. MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
6. In the opinion of the investigator, participation would not be in the best interest of the subject.
7. Taking prescription medications twice a day that need to be taken with food.

Primary outcomes:
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Average number of days per week of time-restricted eating
timeFrame: The eating window is assessed daily throughout the 3-month intervention.
Secondary outcomes:
measure: Physical Activity and Sedentary Behavior Questionnaire Score
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Memory as measured by the Comprehensive TrailMaking Test (CTMT)
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Verbal Memory as Measured by the Auditory VerbalLearning Test (AVLT)
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Psychological Flexibility as Measured by the Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Brief Resilience Scale (BRS) Score
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Perceived Stress Scale (PSS) Score
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: WHO Quality of Life Questionnaire
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Hemoglobin A1c
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention)
measure: C-reactive protein
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
measure: Blood Pressure
timeFrame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University, College of Health Solutions
state: Arizona
city: Phoenix
country: United States
facility: Barrow Neurological Institute, Division of Alzheimer's Disease
state: Arizona
Study officials:
affiliation: Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division
name: Yonas E Geda, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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