Time-Restricted Eating for Mild Cognitive Impairment

Overseen By Julie S Pendergast, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Julie Pendergast

Must not be taking: Eating behavior meds

Disqualifiers: Hypoglycemia, Liver disease, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (also known as intermittent fasting or the 16:8 eating pattern) can aid women with mild cognitive impairment. The study focuses on women due to their higher risk of developing Alzheimer’s disease compared to men. Participants will consume all meals within a 10-hour window each day for eight weeks to assess potential improvements in brain function. Women who have undergone menopause and have been diagnosed with mild cognitive impairment might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new insights into brain health.

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 prior data suggests that time-restricted eating is safe for females with mild cognitive impairment?

Research has shown that time-restricted eating (TRE) is generally safe and easy for most people to follow. In studies with older adults, fasting for 16 hours proved doable and easy to adapt to, with most participants managing it without major issues.

TRE might also offer additional benefits. It may help protect the brain and support mental health, possibly reducing the risk of memory problems. This method involves eating all meals within a 10-hour period each day, which could improve brain function.

Overall, based on current research, TRE appears to be a promising and safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Time-restricted eating is unique because it focuses on when you eat, rather than what you eat, which is different from most current treatments for mild cognitive impairment that might include medications or cognitive training. This method encourages eating all daily calories within a self-selected 10-hour window, potentially enhancing metabolic health and cognitive function. Researchers are excited about this approach because it could offer a simple, non-invasive way to support brain health and improve cognitive outcomes without the need for drugs or complex interventions.

What evidence suggests that time-restricted eating might be an effective treatment for mild cognitive impairment?

Research shows that time-restricted eating (TRE), which participants in this trial will follow, might benefit brain health and mental well-being. Studies suggest that TRE can slow brain aging and memory loss by supporting processes that protect the brain. Some research has linked TRE to better brain health, indicating it might help improve brain function. Additionally, TRE is considered safe and easy for older adults to follow. Overall, these findings support the idea that TRE could effectively address mild memory problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Julie Pendergast, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating

Trial Overview The 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.

How Is the Trial Designed?

Group I: Time-restricted eating Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Julie Pendergast

Lead Sponsor

Trials

3

Recruited

250+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Time-restricted feeding (TRF) without caloric restriction significantly improved various aspects of Alzheimer's disease in two transgenic mouse models, including reducing amyloid deposition and enhancing memory.

TRF also normalized daily gene transcription patterns related to Alzheimer's and neuroinflammation, suggesting it could be a promising, accessible intervention to slow down or halt the progression of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian modulation by time-restricted feeding rescues brain pathology and improves memory in mouse models of Alzheimer's disease. Whittaker, DS., Akhmetova, L., Carlin, D., et al.[2023]

Time-restricted eating (TRE) significantly reduces body weight and fat mass, with an average weight loss of 1.60 kg and fat loss of 1.48 kg in a meta-analysis of 17 studies involving 899 participants.

TRE particularly benefits overweight individuals, leading to improvements in lipid profiles, including lower triglycerides, total cholesterol, and LDL cholesterol, although it does not significantly affect waist circumference or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Liu, L., Chen, W., Wu, D., et al.[2022]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

In a study of 95 adults with metabolic syndrome, time-restricted feeding (TRF) during Ramadan led to significant reductions in arterial stiffness and improved cardiovascular markers, such as pulse wave velocity and central systolic pressure.

The Ramadan fasting group showed notable improvements in arterial health, suggesting that TRF could be a beneficial dietary strategy for enhancing cardiovascular health and potentially extending lifespan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. Alinezhad-Namaghi, M., Eslami, S., Nematy, M., et al.[2023]

In a study of 1353 older adults in Shanghai, time-restricted feeding (TRF) was linked to a higher incidence of cognitive impairment, suggesting that limiting eating to a shorter time window may negatively affect cognitive health.

TRF was found to be significantly associated with lower scores in cognitive functions such as 'Orientation to place' and 'Attention/calculation', indicating that restricting meal times could impair specific areas of cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. Li, J., Li, R., Lian, X., et al.[2023]

Time-restricted eating (TRE) shows promise as a potential lifestyle intervention to help protect cognitive function and reduce neuroinflammatory markers associated with Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI), based on preliminary evidence.

Despite the potential benefits of TRE, there is currently no research specifically examining its effects on sleep disturbances in individuals with AD, highlighting the need for further randomized controlled trials to explore its impact on cognition in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of time-restricted eating on sleep, cognitive decline, and Alzheimer's disease. Ezzati, A., Pak, VM.[2022]

In a 12-week study involving 20 adults with a BMI of 25 kg/m2 or higher, time-restricted eating (TRE) significantly reduced the frequency of eating occasions by 28% compared to only 12% in the non-TRE group, indicating a more structured eating pattern.

TRE participants also reported a notable decrease in both high and low-quality snacks and caffeinated beverage intake, suggesting that this eating pattern not only aids in weight loss but also promotes healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. Malaeb, S., Harindhanavudhi, T., Dietsche, K., et al.[2022]

Time-restricted feeding (TRF) for 16 hours a day over four weeks led to a significant average weight loss of 2.6 kg in a pilot study involving 10 overweight, sedentary older adults, indicating its potential as a weight management strategy.

Participants also experienced clinically meaningful improvements in walking speed and quality of life, with high adherence rates (84%) and few reported adverse events, suggesting that TRF is a safe and feasible dietary approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. Anton, SD., Lee, SA., Donahoo, WT., et al.[2020]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11107340/

Effect of time-restricted eating and intermittent fasting on ... The findings suggest that TRE and IFA may have a positive impact on cognitive function and mental health in this population.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06429124

Time Restricted Eating in Alzheimer's Disease 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 ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425001383

Time-Restricted Eating in Alzheimer's Disease: TREAD ... Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective.

4. sciencedirect.com sciencedirect.com/science/article/pii/S127977072500003X

Intermittent fasting and neurocognitive disorders: What the ... Intermittent fasting (IF) has emerged as a potential lifestyle intervention for mitigating cognitive decline and enhancing brain health.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7827225/

Association between Time Restricted Feeding and ... The results of this study reveal that time restricted eating may be positively associated with cognitive status, and thus exert plausible effects on brain ...

6. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Time_restricted_eating.pdf

Time restricted eating Time-restricted eating protocols have been found to protect against cognitive impairment in rodent models of vascular dementia. In the bilateral common carotid ...