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

Trial Summary

What is the purpose of this trial?

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

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 data supports the effectiveness of the treatment Time-Restricted Eating for Metabolic Syndrome in Postmenopausal Women?

Research shows that time-restricted eating (TRE) can help improve weight, blood pressure, and cholesterol levels in people with metabolic syndrome. Studies have found that TRE can enhance cardiometabolic health, even when combined with standard medical treatments like statins and blood pressure medications. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) has been studied in humans and is generally considered safe, with research showing it can improve weight, blood pressure, and other health markers in people with metabolic syndrome and obesity. ^{1 2 6 7 8}

How is the treatment Time-Restricted Eating different from other treatments for metabolic syndrome?

Time-Restricted Eating (TRE) is unique because it focuses on limiting the time window for eating each day, rather than changing what or how much you eat. This approach can improve metabolic health by aligning eating patterns with the body's natural circadian rhythms, potentially enhancing the effects of standard medications like statins and blood pressure drugs. ^{1 2 3 4 6}

Research Team

Julie S Pendergast, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

References

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

Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. [2021]

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

Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. [2023]

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

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

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

Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating and Metabolic Syndrome: Current Status and Future Perspectives. [2021]

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

Time restricted eating as a weight loss intervention in adults with obesity. [2021]

7. United States 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. [2023]

8. 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]