Time Restricted Eating in Alzheimer's Disease (TREAD)

Intermittent Fasting Clinical Trial

— TREAD  

Official title:

Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429124
• Other study ID #: HX-23-500-347-30-03
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: March 14, 2026

Study information

• Verified date: June 2024
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: Yonas E Geda, MD, MSc
• Phone: 833-233-3073
• Email: yonas.geda[@]commonspirit.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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'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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 14, 2026
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. aged 60-80 years

2. meet criteria for MCI

3. body mass index >18.5 and <40.0 kg/m2

4. access to the internet through computer or smart phone

5. supportive family member (e.g., spouse or adult child) who will help to facilitate study visits and intervention activities

6. education level > 8 years

7. 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.

Exclusion Criteria:

1. diabetes mellitus that requires insulin treatment or is not well managed

2. eating disorder

3. contraindication to time-restricted eating

Related Conditions & MeSH terms

• Alzheimer Disease
• Intermittent Fasting

Intervention

Behavioral:
• Dietary 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. 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.

Locations

Country	Name	City	State
United States	Arizona State University, College of Health Solutions	Phoenix	Arizona
United States	Barrow Neurological Institute, Division of Alzheimer's Disease	Phoenix	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	Arizona State University, Karlsruhe Institute of Technology, Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Insulin resistance will be estimated using HOMA-IR.	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Primary	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.	The eating window is assessed daily throughout the 3-month intervention.
Secondary	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)	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	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).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	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).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	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).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Working Memory as measured by the WAIS-IV Digit Span Forward/Backward	The Digit Span Forward/Backward is a subset of the Wechsler Adult Intelligence Scale (WAIS) that captures attention efficiency and working memory.	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Psychological Flexibility as Measured by the Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)	The Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) is a 23 item questionnaire that measures ACT processes, including psychological flexibility (Francis et al., 2016).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Brief Resilience Scale (BRS) Score	The Brief Resilience Scale (BRS) has 6 items and is a reliable means of assessing resilience as the ability to bounce back or recover from stress (Smith et al., 2008).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Perceived Stress Scale (PSS) Score	The Perceived Stress Scale (PSS) is used for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes questions about current levels of experienced stress (Cohen et al, 1983).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Pittsburgh Sleep Quality Index (PSQI) Score	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire designed to measure sleep quality and disturbance over past month (Buysse et al.,1989).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	WHO Quality of Life Questionnaire	The WHO QOL has four domains (physical health, psychological, social relationships, and environment). The four domain scores denote an individual's perception of quality of life in each particular domain (WHOQOL Group, 1998).	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Hemoglobin A1c	Glycemic control will be assessed by hemoglobin A1c obtained via venipuncture.	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention)
Secondary	C-reactive protein	Levels of inflammatory biomarkers will be assessed by C-reactive protein obtained via venipuncture.	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Secondary	Blood Pressure	Study staff will be obtaining a participant blood pressure using an electronic blood pressure cuff.	Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).