Mild Cognitive Impairment (MCI)
Conditions
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Intermittent Fasting, Nutritional Strategies, Time Restricted Eating
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'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.
Interventions
BEHAVIORALDietary 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.
Sponsors
Arizona State University
Karlsruhe Institute of Technology
Mayo Clinic
St. Joseph's Hospital and Medical Center, Phoenix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
This study will not use any masking.
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
| 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). | 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). |
| 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). | The Digit Span Forward/Backward is a subset of the Wechsler Adult Intelligence Scale (WAIS) that captures attention efficiency and working memory. |
| Psychological Flexibility as Measured by the Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | 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). |
| Brief Resilience Scale (BRS) Score | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | 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). |
| Physical Activity and Sedentary Behavior Questionnaire Score | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | The Physical Activity and Sedentary Behavior Questionnaire will assess active time and time spent on exercise (PASB-Q; English Version) (Sattler et al., 2020) |
| Pittsburgh Sleep Quality Index (PSQI) Score | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | 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). |
| WHO Quality of Life Questionnaire | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | 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). |
| Hemoglobin A1c | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention) | Glycemic control will be assessed by hemoglobin A1c obtained via venipuncture. |
| C-reactive protein | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | Levels of inflammatory biomarkers will be assessed by C-reactive protein obtained via venipuncture. |
| Blood Pressure | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | Study staff will be obtaining a participant blood pressure using an electronic blood pressure cuff. |
| Perceived Stress Scale (PSS) Score | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | 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). |
| Memory as measured by the Comprehensive TrailMaking Test (CTMT) | Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). | The Comprehensive Trail Making Test (CTMT) is a measure of organized visual search, attention, set shifting and divided attention (Reynolds 2002). |
Countries
United States
Contacts
Primary ContactYonas E Geda, MD, MSc
Backup ContactGeetika Chahal, MBBS
Outcome results
None listed