Time Restricted Eating in Alzheimer's Disease

NCT06429124 | Recruiting

• 1 other identifier: HX-23-500-347-30-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Alzheimer's Disease; Mild Cognitive Impairment; Intermittent Fasting; Nutritional Strategies; Time Restricted Eating

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (13)

• Physical Activity and Sedentary Behavior Questionnaire Score

  Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).

• Memory as measured by the Comprehensive TrailMaking Test (CTMT)

  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)

  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)

  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

  Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).

Study Arms (1)

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.

Behavioral: Dietary Intervention

Interventions

Dietary Intervention BEHAVIORAL

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.

Interventional

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Arizona State University: collaborator
• Karlsruhe Institute of Technology: collaborator
• Mayo Clinic: collaborator

Study Sites (2)

Arizona State University, College of Health Solutions

Phoenix, Arizona, 85004, United States

RECRUITING

Barrow Neurological Institute, Division of Alzheimer's Disease

Phoenix, Arizona, 85013, United States

ENROLLING BY INVITATION

Related Publications (35)

• 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.

  PMID: 12724520 BACKGROUND

• Anton 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.

  PMID: 31262054 BACKGROUND

• Anton 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.

  PMID: 29086496 BACKGROUND

• Brookmeyer 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.

  PMID: 9736873 BACKGROUND

• Buysse 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.

  PMID: 2748771 BACKGROUND

• Carlson 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.

  PMID: 21021020 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Dimitratos 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.

  PMID: 32706729 BACKGROUND

• Folstein 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.

  PMID: 1202204 BACKGROUND

• Francis, A. W., D. L. Dawson and N. Golijani-Moghaddam (2016).

  BACKGROUND

• 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.

  PMID: 2402168 BACKGROUND

• Goodrick 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.

  PMID: 6848584 BACKGROUND

• Gudden 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.

  PMID: 34579042 BACKGROUND

• Halagappa 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.

  PMID: 17306982 BACKGROUND

• HARMAN 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.

  PMID: 13332224 BACKGROUND

• Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.

  PMID: 29653606 BACKGROUND

• Lee SA, Sypniewski C, Bensadon BA, McLaren C, Donahoo WT, Sibille KT, Anton S. Determinants of Adherence in Time-Restricted Feeding in Older Adults: Lessons from a Pilot Study. Nutrients. 2020 Mar 24;12(3):874. doi: 10.3390/nu12030874.

  PMID: 32213965 BACKGROUND

• Martens CR, Rossman MJ, Mazzo MR, Jankowski LR, Nagy EE, Denman BA, Richey JJ, Johnson SA, Ziemba BP, Wang Y, Peterson CM, Chonchol M, Seals DR. Short-term time-restricted feeding is safe and feasible in non-obese healthy midlife and older adults. Geroscience. 2020 Apr;42(2):667-686. doi: 10.1007/s11357-020-00156-6. Epub 2020 Jan 23.

  PMID: 31975053 BACKGROUND

• Mattson MP, Moehl K, Ghena N, Schmaedick M, Cheng A. Intermittent metabolic switching, neuroplasticity and brain health. Nat Rev Neurosci. 2018 Feb;19(2):63-80. doi: 10.1038/nrn.2017.156. Epub 2018 Jan 11.

  PMID: 29321682 BACKGROUND

• McCay CM, Crowell MF, Maynard LA. The effect of retarded growth upon the length of life span and upon the ultimate body size. 1935. Nutrition. 1989 May-Jun;5(3):155-71; discussion 172. No abstract available.

  PMID: 2520283 BACKGROUND

• Mitchell SJ, Bernier M, Mattison JA, Aon MA, Kaiser TA, Anson RM, Ikeno Y, Anderson RM, Ingram DK, de Cabo R. Daily Fasting Improves Health and Survival in Male Mice Independent of Diet Composition and Calories. Cell Metab. 2019 Jan 8;29(1):221-228.e3. doi: 10.1016/j.cmet.2018.08.011. Epub 2018 Sep 6.

  PMID: 30197301 BACKGROUND

• Ooi TC, Meramat A, Rajab NF, Shahar S, Ismail IS, Azam AA, Sharif R. Intermittent Fasting Enhanced the Cognitive Function in Older Adults with Mild Cognitive Impairment by Inducing Biochemical and Metabolic changes: A 3-Year Progressive Study. Nutrients. 2020 Aug 30;12(9):2644. doi: 10.3390/nu12092644.

  PMID: 32872655 BACKGROUND

• Ooi TC, Meramat A, Rajab NF, Shahar S, Sharif R. Antioxidant Potential, DNA Damage, Inflammation, Glycemic Control and Lipid Metabolism Alteration: A Mediation Analysis of Islamic Sunnah Intermittent Fasting on Cognitive Function among Older Adults with Mild Cognitive Impairment. J Nutr Health Aging. 2022;26(3):272-281. doi: 10.1007/s12603-022-1757-0.

  PMID: 35297471 BACKGROUND

• Reiman EM, Caselli RJ, Yun LS, Chen K, Bandy D, Minoshima S, Thibodeau SN, Osborne D. Preclinical evidence of Alzheimer's disease in persons homozygous for the epsilon 4 allele for apolipoprotein E. N Engl J Med. 1996 Mar 21;334(12):752-8. doi: 10.1056/NEJM199603213341202.

  PMID: 8592548 BACKGROUND

• Rey, A. (1964). L'examen clinique en psychologie. Paris, Presses Universitaires de France.

  BACKGROUND

• Reynolds, C. R. (2002). Comprehensive trail-making test : examiner's manual. Austin, Tex., Pro-Ed.

  BACKGROUND

• Roy M, Rheault F, Croteau E, Castellano CA, Fortier M, St-Pierre V, Houde JC, Turcotte EE, Bocti C, Fulop T, Cunnane SC, Descoteaux M. Fascicle- and Glucose-Specific Deterioration in White Matter Energy Supply in Alzheimer's Disease. J Alzheimers Dis. 2020;76(3):863-881. doi: 10.3233/JAD-200213.

  PMID: 32568202 BACKGROUND

• Rubinsztein DC, Frake RA. Yoshinori Ohsumi's Nobel Prize for mechanisms of autophagy: from basic yeast biology to therapeutic potential. J R Coll Physicians Edinb. 2016 Dec;46(4):228-233. doi: 10.4997/jrcpe.2016.403.

  PMID: 28504774 BACKGROUND

• Sattler MC, Jaunig J, Tosch C, Watson ED, Mokkink LB, Dietz P, van Poppel MNM. Current Evidence of Measurement Properties of Physical Activity Questionnaires for Older Adults: An Updated Systematic Review. Sports Med. 2020 Jul;50(7):1271-1315. doi: 10.1007/s40279-020-01268-x.

  PMID: 32125670 BACKGROUND

• Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

  PMID: 18696313 BACKGROUND

• Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.

  PMID: 29754952 BACKGROUND

• Wechsler, D. (1997). Wechsler Adult Intelligence Scale-III. New York, The Psychological Corporation.

  BACKGROUND

• Weindruch R. The retardation of aging by caloric restriction: studies in rodents and primates. Toxicol Pathol. 1996 Nov-Dec;24(6):742-5. doi: 10.1177/019262339602400618.

  PMID: 8994305 BACKGROUND

• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

  PMID: 9626712 BACKGROUND

• Wilson, K. G., Sandoz, E. K., Kitchens, J., & Roberts, M. E. (2010).

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Intermittent Fasting

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Yonas E Geda, MD, MSc

  Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonas E Geda, MD, MSc

CONTACT

833-233-3073; yonas.geda@commonspirit.org

Geetika Chahal, MBBS

CONTACT

602-406-7240; geetika.chahal@commonspirit.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study will not use any masking.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 24, 2024
• Study Start: March 15, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 14, 2026
• Last Updated: June 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)