Time-Restricted Eating for Metabolic Syndrome in Postmenopausal Women

Overseen By Matt Thomas, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Julie Pendergast

Must not be taking: ADHD medications

Disqualifiers: Diabetes, Heart disease, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

164 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating, which involves consuming all daily meals within a 10-hour period, can improve health in postmenopausal women with metabolic issues. Researchers aim to determine if this eating pattern can boost insulin sensitivity, improve glucose tolerance, aid in weight management, and enhance overall metabolic health. Participants are divided into two groups: one follows their usual eating habits, while the other adopts time-restricted eating for 16 weeks. Women who are postmenopausal, aged 45-65, and either prediabetic or showing signs of metabolic syndrome are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve health outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on hormone therapy or ADHD medications, you would not be eligible to participate.

What prior data suggests that time-restricted feeding is safe for postmenopausal women?

Research shows that time-restricted feeding (TRF) is generally safe for most people. Studies have found that TRF can help lower insulin levels and support weight loss. For instance, one study observed that women, both before and after menopause, lost about 3.3% of their body weight in eight weeks, with no major safety concerns.

Another study found that TRF improved participants' quality of life based on their own reports. Importantly, these studies did not find any significant negative effects from TRF, suggesting that most people can handle it well.

As with any change in diet, individuals should consider their own health needs and consult a healthcare provider. Overall, current research suggests that TRF is a safe way to help manage weight and improve metabolic health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted feeding (TRF) for tackling metabolic syndrome in postmenopausal women because it offers a non-pharmacological approach to managing this condition. Unlike traditional treatments like medications for lowering blood sugar or cholesterol, TRF focuses on the timing of eating, allowing participants to consume all their daily calories within a self-selected 10-hour window. This method may help regulate metabolism and improve metabolic health markers without the need for drugs, potentially reducing side effects and making it easier to adhere to in the long run. Additionally, it taps into the body's natural circadian rhythms, which could enhance its effectiveness compared to other dietary interventions.

What evidence suggests that time-restricted feeding might be an effective treatment for metabolic syndrome?

Research has shown that time-restricted feeding (TRF), which participants in this trial may follow, can aid in weight loss and enhance overall health. One study found that postmenopausal women lost about 3.3% of their body weight after following TRF for eight weeks. Another study demonstrated that TRF significantly improved insulin levels, aiding in blood sugar control. TRF has also effectively reduced body fat and waist size. These findings suggest that TRF could be a useful method for improving health in postmenopausal women. ^{1 2 3 4 6}

Who Is on the Research Team?

Julie S Pendergast, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 45-65 who are prediabetic or show at least two signs of metabolic syndrome and lead a sedentary lifestyle. It's not suitable for those with significant sleep disruptions, psychiatric disorders, heart disease, uncontrolled sleep issues, heavy alcohol use, eating disorders, diabetes, extreme sleeping patterns or those doing shift work.

Inclusion Criteria

I am a woman who has gone through menopause.

I am prediabetic or have at least 2 symptoms of metabolic syndrome.

I am between 45 and 65 years old.

Exclusion Criteria

You have caregiving duties that greatly affect your sleep.

You have been diagnosed with eating behaviors that are not normal or healthy.

You drink more than 2 alcoholic drinks every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Baseline data collection including food timing, activity/sleep, and metabolic parameters

2 weeks

1 visit (in-person)

Treatment

Participants are randomized to either the TRF intervention or no TRF for 16 weeks. TRF group self-selects a 10-hour eating window.

16 weeks

Weekly text updates

Follow-up

Participants are monitored for changes in metabolic and anthropometric measurements post-intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time-Restricted Feeding

Trial Overview

The study is testing if eating within a set time frame each day (time-restricted feeding) can improve health markers like blood sugar control and body weight in metabolically-unhealthy postmenopausal women. Participants will be randomly assigned to one of two groups to compare the effects.

How Is the Trial Designed?

Group I: Time-Restricted Feeding (TRF) Group Experimental Treatment 1 Intervention

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.

Group II: Control Active Control 1 Intervention

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.

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 eating (TRE) shows potential for lowering blood pressure in adults with metabolic syndrome, particularly when meals are consumed earlier in the day and within narrower eating windows.

Current studies on TRE and blood pressure outcomes are limited and inconsistent, highlighting the need for more research to explore the effects of TRE on blood pressure variability throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. Duan, D., Bhat, S., Jun, JC., et al.[2023]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

The TREMNIOS pilot clinical trial aims to assess the feasibility of a 10-hour time-restricted eating (TRE) intervention over 12 weeks in Polish adults with metabolic syndrome, focusing on its effects on various health biomarkers and daily behavior rhythms.

This study will utilize validated monitoring tools and aims to establish a foundation for a larger randomized controlled trial to evaluate the efficacy of TRE in improving cardiometabolic health in individuals with metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. Świątkiewicz, I., Mila-Kierzenkowska, C., Woźniak, A., et al.[2021]

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]

In a study of 36 women with overweight or obesity, those following an 8-week time-restricted eating (TRE) plan experienced greater weight loss and reductions in body fat compared to a non-TRE group, despite both groups following a caloric restriction diet.

The weight loss observed in the TRE group was not linked to changes in resting metabolic rate or improvements in mood or eating disorder symptoms, suggesting that TRE can be effective for weight loss without affecting these behavioral factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic and behavioral effects of time-restricted eating in women with overweight or obesity: Preliminary findings from a randomized study. Fagundes, GBP., Tibães, JRB., Silva, ML., et al.[2023]

In a study involving 19 participants with metabolic syndrome, a 12-week time-restricted eating (TRE) intervention improved cardiometabolic health, suggesting it can be an effective lifestyle change alongside standard medical treatments.

The majority of participants were already on medications like statins and antihypertensives, indicating that TRE may work synergistically with pharmacotherapy to enhance health outcomes in patients with metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Wilkinson, MJ., Manoogian, ENC., Zadourian, A., et al.[2021]

Time-restricted eating (TRE) shows promise in improving cardiometabolic health in individuals with metabolic syndrome (MetS) by aligning eating patterns with circadian rhythms, potentially mitigating risks associated with obesity, diabetes, and cardiovascular disease.

Pilot studies have indicated that TRE can lead to significant improvements in body weight, abdominal obesity, and blood pressure without requiring changes in diet quality or physical activity, highlighting its potential as a simple intervention for MetS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating and Metabolic Syndrome: Current Status and Future Perspectives. Świątkiewicz, I., Woźniak, A., Taub, PR.[2021]

Time-restricted eating (TRE), which limits calorie intake to 6- to 10-hour periods during the active part of the day, has been shown to improve various aspects of metabolic health, including weight loss, glucose tolerance, and cardiovascular health, based on both preclinical and human studies.

Implementing TRE can help mitigate the negative effects of eating out of sync with our body's natural circadian rhythms, potentially reducing the risk of chronic diseases, although there are challenges in applying this dietary approach in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. Regmi, P., Heilbronn, LK.[2021]

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This study aims to compare the effects of early and delayed time-restricted eating on metabolic syndrome parameters in obese women. Detailed Description.