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Time-Restricted Eating for Metabolic Syndrome in Postmenopausal Women

N/A

Recruiting

Led By Julie S Pendergast, PhD

Research Sponsored by Julie Pendergast

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal women

Age 45-65 years

Must not have

Heart disease

Uncontrolled sleep apnea or sleep disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks (baseline and post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether time-restricted eating can improve metabolic health in postmenopausal women.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include hunger outside of designated eating times or potential changes in energy levels. Specific side effects will depend on individual responses to the time-restricted feeding schedule.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who has gone through menopause.

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I am between 45 and 65 years old.

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I am a woman who has gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart disease.

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I have a sleep disorder that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks (baseline and post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks (baseline and post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks (baseline and post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Body Mass Index

Change in Insulin Sensitivity

Change in Triglycerides

Secondary study objectives

Change in C-Reactive Protein

Change in Hemoglobin A1c

Change in Mid-sleep

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time-Restricted Feeding (TRF) GroupExperimental Treatment1 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: ControlActive Control1 Intervention

0 / 5Eligibility criteria met