Time-Restricted Eating for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Overseen byJulie Pendergast, PhD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Julie Pendergast
Must not be taking: Eating behavior meds
Disqualifiers: Hypoglycemia, Liver disease, Alcohol, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect eating behaviors.
What data supports the effectiveness of the treatment Time-restricted eating for Mild Cognitive Impairment?
Is time-restricted eating safe for humans?
Time-restricted eating (TRE) is generally considered safe for humans, with studies showing it is an acceptable and feasible eating pattern for older adults, including those who are overweight. However, one study found that it might be associated with a higher incidence of cognitive impairment in older adults, so individuals should consider their personal health conditions and consult with a healthcare provider before starting TRE.13567
How does time-restricted eating differ from other treatments for mild cognitive impairment?
Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which food is consumed each day, rather than changing the types or amounts of food eaten. Unlike other treatments, TRE may help improve memory and reduce inflammation by aligning eating patterns with the body's natural circadian rhythms, which could be beneficial for cognitive health.12489
Eligibility Criteria
This trial is for postmenopausal women aged between 45-95 who have been diagnosed with mild cognitive impairment. It aims to explore a dietary intervention that could potentially improve their condition.Inclusion Criteria
I am between 45 and 95 years old.
I am a woman who has gone through menopause.
I have been diagnosed with mild memory or thinking problems.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
1 visit (in-person)
Baseline Assessment
Baseline food timing, activity/sleep, metabolic health, and cognitive testing are collected
2 weeks
1 visit (in-person)
Treatment
Participants engage in a time-restricted eating intervention, self-selecting a 10-hour window for calorie consumption
8 weeks
Ongoing self-reporting via SMS
Follow-up
Metabolic, anthropometric, activity/sleep, and cognitive measurements are collected post-intervention
2 weeks
1 visit (in-person)
Treatment Details
Interventions
- Time-restricted eating (Behavioral Intervention)
Trial OverviewThe study is testing the feasibility of time-restricted eating as an intervention to see if it can help manage or improve mild cognitive impairment in women.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Time-restricted eatingExperimental Treatment1 Intervention
Participants will have baseline and post-study data collected, including activity/sleep data, metabolic parameters (fasting labs and anthropometric measurements), and cognitive testing. In addition, food timing will be collected throughout the study. Subjects will be educated about the potential health benefits of time-restricted eating and will self-select a 10-hr window, during which all daily calories will be consumed for 8 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who Is Running the Clinical Trial?
Julie PendergastLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. [2023]The purpose of this study was to investigate the association between time restricted feeding (TRF) and different areas of cognitive function in the elderly in Chinese communities. This study consisted of 1353 community-dwelling Chinese older adults aged 60 years and older in Chongming area, Shanghai (563 males; the mean age, 73.38 ± 6.16 years). Mild cognitive impairment (MCI) and six different cognitive domains was assessed by the Chinese-version of Mini Mental State Examination (MMSE). Recording the eating time of each meal through oral inquiry to calculate the time window between the first meal and the last meal of the average day. Participants with an eating time window duration of more than 10 h were then identified, as well as those with eating time restricted to less than 10 h (TRF). Our study found that TRF may be associated with a higher incidence rate of cognitive impairment. TRF only limited the eating time window and did not change the frequency of participants' dietary intake. We used a linear regression model to study the association of TRF with cognitive function. After adjusting for confounding variables, the results showed that TRF was related to MMSE score (P
Circadian modulation by time-restricted feeding rescues brain pathology and improves memory in mouse models of Alzheimer's disease. [2023]Circadian disruptions impact nearly all people with Alzheimer's disease (AD), emphasizing both their potential role in pathology and the critical need to investigate the therapeutic potential of circadian-modulating interventions. Here, we show that time-restricted feeding (TRF) without caloric restriction improved key disease components including behavioral timing, disease pathology, hippocampal transcription, and memory in two transgenic (TG) mouse models of AD. We found that TRF had the remarkable capability of simultaneously reducing amyloid deposition, increasing Aβ42 clearance, improving sleep and memory, and normalizing daily transcription patterns of multiple genes, including those associated with AD and neuroinflammation. Thus, our study unveils for the first time the pleiotropic nature of timed feeding on AD, which has far-reaching effects beyond metabolism, ameliorating neurodegeneration and the misalignment of circadian rhythmicity. Since TRF can substantially modify disease trajectory, this intervention has immediate translational potential, addressing the urgent demand for accessible approaches to reduce or halt AD progression.
The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. [2020]A growing body of evidence indicates that time restricted feeding (TRF), a popular form of intermittent fasting, can activate similar biological pathways as caloric restriction, the only intervention consistently found to extend healthy lifespan in a variety of species. Thus, TRF may have the potential to also improve function in older adults. Given the challenges many individuals have in following calorie restriction regimens over long-time periods, evaluation of alternative approaches that may produce weight loss and improve function in overweight, older adults is important. Ten overweight, sedentary older adults (≥65 years) at risk for, or with mobility impairments, defined by slow gait speed (<1.0 m/s) participated in this trial. All participants received the intervention and were instructed to fast for approximately 16 h per day over the entire four-week intervention. Outcomes included changes in body weight, waist circumference, cognitive and physical function, health-related quality of life, and adverse events. Adherence levels were high (mean = 84%) based on days goal was met, and mean weight loss was 2.6 kg (p < 0.01). Since body composition was not measured in this study, it is unclear if the observed weight loss was due to loss of fat mass, muscle mass, or the combination of fat and muscle mass. There were no significant changes in other outcomes; however, there were clinically meaningful changes in walking speed and improvements in quality of life, with few reported adverse events. The findings of this pilot study suggest that time restricted feeding is an acceptable and feasible eating pattern for overweight, sedentary older adults to follow.
Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]Time-restricted eating (TRE) can facilitate weight loss, yet its effect on eating patterns remains unknown. Twenty adults with BMI ≥ 25 kg/m2 underwent a 12-week randomized trial, examining the effect of an 8-h, time-restricted eating intervention on dietary patterns. Oral intake was documented using a smartphone. Dietary patterns, assessed as frequency of eating occasions (EOs) and types of meals/snacks and beverages, were compared between baseline (T0), early-intervention (T1), and end-intervention (T2). At T1 and T2, both groups had less EOs compared to T0, with greater reduction seen in the TRE group (-28%) than the non-TRE group (-12%) at T2 (p = 0.01 vs. non-TRE). Comparing T1 to T0, the TRE group documented less incomplete meals (-32.5%: p = 0.02), high quality snacks (-23.6%: p = 0.03), and low quality snacks (-36.6%: p = 0.004). Comparing T2 to T0, the TRE group documented less incomplete meals (-33.9%: p = 0.03), high quality snacks (-28.1%: p < 0.001) and low quality snacks (-51.2%: p < 0.001). Caffeinated beverage intake was reduced in the TRE group at T1 (-20.2%) and T2 (-28.8%) vs. T0, but remained unaltered in the non-TRE group. By using a smartphone application to document dietary intake, TRE significantly reduced the number of EOs, snacks, and caffeinated beverages, relative to baseline and relative to the non-TRE.
Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We also investigated the effect of the low-calorie, high-fat, low-carbohydrate, and low-protein "fasting snack" on blood glucose.
Time-Restricted Eating to Improve Cardiovascular Health. [2021]Time-restricted eating (TRE) is a form of intermittent fasting that involves confining the eating window to 4-10 h and fasting for the remaining hours of the day. The purpose of this review is to summarize the current literature pertaining to the effects of TRE on body weight and cardiovascular disease risk factors.
Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. [2023]Time-restricted feeding (TRF) is a kind of intermittent fasting defined as eating and drinking only during a certain number of hours in a day. It has been suggested that intermittent fasting may improve cardiovascular risk factors. This study evaluated the association of TRF and arterial stiffness, using pulse wave velocity (PWV), pulse wave analysis, and arterial age in metabolic syndrome participants.
The effects of time-restricted eating on sleep, cognitive decline, and Alzheimer's disease. [2022]According to the United Nations, by 2050, one in six individuals will be over age 65 globally, and one in four people would be aged 65 and older in western countries. The unprecedented growth of the aging population is associated with increased age-related disorders like Alzheimer's disease (AD) and Mild cognitive impairment (MCI). To date, no cure is known for AD, thus lifestyle interventions including calorie restriction (CR) and time-restricted eating (TRE) are proposed as potential approach to delay the onset and progression of the disease. Sleep disturbances are common in people with MCI and AD. Moreover, accumulating data indicates that pro-inflammatory cytokines including tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1β), IL-6, IL-8 and IL-10 increase in individuals with AD and MCI versus healthy subjects. Thus, the purpose of the present review is to describe the potential effects of TRE on sleep, cognition decline, and neuroinflammatory markers in humans. Preliminary evidence suggests that TRE may produce neuroprotective effects on cognition and reduce neuroinflammatory markers related to AD in humans. To date, no studies investigated the effects of TRE on sleep disturbances and patients with AD. Thereby, the impact of TRE on cognition in individuals with cognitive decline and AD needs to be investigated further in randomized controlled trials (RCTs).
Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]Time-restricted eating (TRE), which restricts food intake to a limited duration of the day, is a key regimen of intermittent fasting.