Mild Cognitive Impairment (MCI)TREADNCT06429124
Time Restricted Eating in Alzheimer's Disease
A study testing Dietary Intervention in people with Mild Cognitive Impairment (MCI), run by St. Joseph's Hospital and Medical Center, Phoenix at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2023to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Access to the internet through computer or smartphone.
- 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.
Show all 9Show fewer
- An education level > 8 years.
- 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.
- Vision and hearing must be sufficient to comply with study procedures.
Who cannot join
- 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.
- MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
- In the opinion of the investigator, participation would not be in the best interest of the subject.
- Taking prescription medications twice a day that need to be taken with food.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Arizona State University, College of Health Solutions
Phoenix, Arizona, 85004
Susan Racette, Ph.D., 602-543-1563, Susan.Racette@asu.edu
- Enrolling by invitation
Barrow Neurological Institute, Division of Alzheimer's Disease
Phoenix, Arizona, 85013
About this study
Official title: Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D 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.
Read the 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\&#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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Dietary Intervention
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Intermittent Fasting, Nutritional Strategies, Time Restricted Eating
- Medical subject headings
- Cognitive Dysfunction, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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. Receives: Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance will be estimated using HOMA-IR.
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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.
Measured: The eating window is assessed daily throughout the 3-month intervention.
Secondary outcomes (13)
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)
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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.
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
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).
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Hemoglobin A1c
Glycemic control will be assessed by hemoglobin A1c obtained via venipuncture.
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention)
C-reactive protein
Levels of inflammatory biomarkers will be assessed by C-reactive protein obtained via venipuncture.
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Blood Pressure
Study staff will be obtaining a participant blood pressure using an electronic blood pressure cuff.
Measured: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Mar 2023
- Primary completionDec 2025 (estimated)
- Study completion14 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Karlsruhe Institute of Technology, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Yonas E Geda, MD, MSc, Principal investigator, Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429124
- Sponsor's protocol ID
- HX-23-500-347-30-03
- Acronym
- TREAD
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of this proposed Barrow Neurological Foundation project will provide critical preliminary data for a future large-scale R01 grant application to the National Institutes of Health (NIH), but no individual participant data will be shared.
Publications
Anson RM, Guo Z, de Cabo R, Iyun T, Rios M, Hagepanos A, Ingram DK, Lane MA, Mattson MP. Intermittent fasting dissociates beneficial effects of dietary restriction on glucose metabolism and neuronal resistance to injury from calorie intake. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6216-20. doi: 10.1073/pnas.1035720100. Epub 2003 Apr 30.
PubMed 12724520Anton SD, Lee SA, Donahoo WT, McLaren C, Manini T, Leeuwenburgh C, Pahor M. The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. Nutrients. 2019 Jun 30;11(7):1500. doi: 10.3390/nu11071500.
PubMed 31262054Anton SD, Moehl K, Donahoo WT, Marosi K, Lee SA, Mainous AG 3rd, Leeuwenburgh C, Mattson MP. Flipping the Metabolic Switch: Understanding and Applying the Health Benefits of Fasting. Obesity (Silver Spring). 2018 Feb;26(2):254-268. doi: 10.1002/oby.22065. Epub 2017 Oct 31.
PubMed 29086496Brookmeyer R, Gray S, Kawas C. Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. Am J Public Health. 1998 Sep;88(9):1337-42. doi: 10.2105/ajph.88.9.1337.
PubMed 9736873Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Carlson AJ, Hoelzel F. Apparent prolongation of the life span of rats by intermittent fasting. J Nutr. 1946 Mar;31:363-75. doi: 10.1093/jn/31.3.363. No abstract available.
PubMed 21021020Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Dimitratos SM, German JB, Schaefer SE. Wearable Technology to Quantify the Nutritional Intake of Adults: Validation Study. JMIR Mhealth Uhealth. 2020 Jul 22;8(7):e16405. doi: 10.2196/16405.
PubMed 32706729Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Francis, A. W., D. L. Dawson and N. Golijani-Moghaddam (2016).
Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider N. Effects of intermittent feeding upon body weight and lifespan in inbred mice: interaction of genotype and age. Mech Ageing Dev. 1990 Jul;55(1):69-87. doi: 10.1016/0047-6374(90)90107-q.
PubMed 2402168Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider NL. Differential effects of intermittent feeding and voluntary exercise on body weight and lifespan in adult rats. J Gerontol. 1983 Jan;38(1):36-45. doi: 10.1093/geronj/38.1.36.
PubMed 6848584Gudden J, Arias Vasquez A, Bloemendaal M. The Effects of Intermittent Fasting on Brain and Cognitive Function. Nutrients. 2021 Sep 10;13(9):3166. doi: 10.3390/nu13093166.
PubMed 34579042Halagappa VK, Guo Z, Pearson M, Matsuoka Y, Cutler RG, Laferla FM, Mattson MP. Intermittent fasting and caloric restriction ameliorate age-related behavioral deficits in the triple-transgenic mouse model of Alzheimer's disease. Neurobiol Dis. 2007 Apr;26(1):212-20. doi: 10.1016/j.nbd.2006.12.019. Epub 2007 Jan 13.
PubMed 17306982HARMAN D. Aging: a theory based on free radical and radiation chemistry. J Gerontol. 1956 Jul;11(3):298-300. doi: 10.1093/geronj/11.3.298. No abstract available.
PubMed 13332224
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial
- ClinicalTrials.gov ID
- NCT06429124
- Acronym / sponsor ID
- TREAD / HX-23-500-347-30-03
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Intermittent Fasting, Nutritional Strategies, Time Restricted Eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Arizona State University, Karlsruhe Institute of Technology, Mayo Clinic
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 14 Mar 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\&#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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Behavioral: Dietary InterventionParticipants 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. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Access to the internet through computer or smartphone.
Key exclusion criteria (7 listed)
- 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.
- MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionParticipants 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. | Behavioural | Interventional |
Primary outcome
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Insulin resistance will be estimated using HOMA-IR.
Average number of days per week of time-restricted eating
Time frame: The eating window is assessed daily throughout the 3-month intervention.
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.
13 secondary outcomes
Physical Activity and Sedentary Behavior Questionnaire Score
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Memory as measured by the Comprehensive TrailMaking Test (CTMT)
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Verbal Memory as Measured by the Auditory VerbalLearning Test (AVLT)
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Psychological Flexibility as Measured by the Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Brief Resilience Scale (BRS) Score
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Perceived Stress Scale (PSS) Score
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
WHO Quality of Life Questionnaire
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Hemoglobin A1c
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention)
C-reactive protein
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Blood Pressure
Time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 12724520Anson RM, Guo Z, de Cabo R, Iyun T, Rios M, Hagepanos A, Ingram DK, Lane MA, Mattson MP. Intermittent fasting dissociates beneficial effects of dietary restriction on glucose metabolism and neuronal resistance to injury from calorie intake. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6216-20. doi: 10.1073/pnas.1035720100. Epub 2003 Apr 30.
- Background: PubMed 31262054Anton SD, Lee SA, Donahoo WT, McLaren C, Manini T, Leeuwenburgh C, Pahor M. The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. Nutrients. 2019 Jun 30;11(7):1500. doi: 10.3390/nu11071500.
- Background: PubMed 29086496Anton SD, Moehl K, Donahoo WT, Marosi K, Lee SA, Mainous AG 3rd, Leeuwenburgh C, Mattson MP. Flipping the Metabolic Switch: Understanding and Applying the Health Benefits of Fasting. Obesity (Silver Spring). 2018 Feb;26(2):254-268. doi: 10.1002/oby.22065. Epub 2017 Oct 31.
- Background: PubMed 9736873Brookmeyer R, Gray S, Kawas C. Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. Am J Public Health. 1998 Sep;88(9):1337-42. doi: 10.2105/ajph.88.9.1337.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 21021020Carlson AJ, Hoelzel F. Apparent prolongation of the life span of rats by intermittent fasting. J Nutr. 1946 Mar;31:363-75. doi: 10.1093/jn/31.3.363. No abstract available.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 32706729Dimitratos SM, German JB, Schaefer SE. Wearable Technology to Quantify the Nutritional Intake of Adults: Validation Study. JMIR Mhealth Uhealth. 2020 Jul 22;8(7):e16405. doi: 10.2196/16405.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- BackgroundFrancis, A. W., D. L. Dawson and N. Golijani-Moghaddam (2016).
- Background: PubMed 2402168Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider N. Effects of intermittent feeding upon body weight and lifespan in inbred mice: interaction of genotype and age. Mech Ageing Dev. 1990 Jul;55(1):69-87. doi: 10.1016/0047-6374(90)90107-q.
- Background: PubMed 6848584Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider NL. Differential effects of intermittent feeding and voluntary exercise on body weight and lifespan in adult rats. J Gerontol. 1983 Jan;38(1):36-45. doi: 10.1093/geronj/38.1.36.
- Individual participant dataSharing planned: No. The results of this proposed Barrow Neurological Foundation project will provide critical preliminary data for a future large-scale R01 grant application to the National Institutes of Health (NIH), but no individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yonas E Geda, MD, MSc principal investigator
Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Mild Cognitive Impairment (MCI), run by St. Joseph's Hospital and Medical Center, Phoenix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonas E Geda, MD, MSc (833-233-3073, yonas.geda@commonspirit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (time frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06429124, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.