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

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?

Research on mice with Alzheimer's disease suggests that time-restricted feeding can improve memory and reduce disease-related brain changes. However, a study on older adults in China found that time-restricted feeding might be linked to poorer cognitive performance, indicating mixed results. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 2 4 8 9}

Research Team

Julie Pendergast, PhD

Principal Investigator

University of Kentucky

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.

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

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Circadian modulation by time-restricted feeding rescues brain pathology and improves memory in mouse models of Alzheimer's disease. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]