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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks (baseline and post-intervention)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Body Mass Index

Change in Insulin Sensitivity

Change in Triglycerides

Secondary outcome measures

Change in C-Reactive Protein

Change in Hemoglobin A1c

Change in Mid-sleep

+1 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Julie PendergastLead Sponsor

2 Previous Clinical Trials

82 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,314,427 Total Patients Enrolled

35 Trials studying Metabolic Syndrome

2,776 Patients Enrolled for Metabolic Syndrome

Julie S Pendergast, PhDPrincipal InvestigatorUniversity of Kentucky

Media Library

Time-Restricted Feeding Clinical Trial Eligibility Overview. Trial Name: NCT04893226 — N/A

Metabolic Syndrome Research Study Groups: Control, Time-Restricted Feeding (TRF) Group

Metabolic Syndrome Clinical Trial 2023: Time-Restricted Feeding Highlights & Side Effects. Trial Name: NCT04893226 — N/A

Time-Restricted Feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893226 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has been approved to participate in this medical experiment?

"Patients with metabolic syndrome, aged between 45 and 65 years old, who fulfill the following criteria - sedentary lifestyle, prediabetes or having at least two features of metabolic syndrome (if applicable postmenopausal women) will be accepted into this clinical trial totalling 164 participants."

Answered by AI

Is this trial actively searching for new participants?

"Affirmative. According to data posted on clinicaltrials.gov, this medical trial is actively accepting participants and was first made available online on October 19th 2021. 164 volunteers are needed from a single test site for the study's completion."

Answered by AI

Is this investigation recruiting participants aged 30 and over?

"This medical trial seeks patients who are between the ages of 45 and 65. Separately, there are 10 studies dedicated to minors and 111 for those surpassing retirement age."

Answered by AI

What key insights are investigators hoping to gain from this clinical experiment?

"The main focus of this 18-week experiment is to observe shifts in Triglyceride levels. Secondary indices, such as Sleep Fragmentation Index (as measured by actigraphy), Hemoglobin A1c content, and C-Reactive Protein concentrations will also be closely monitored."

Answered by AI

What is the maximum participant capacity for this experiment?

"Affirmative. The information published on clinicaltrials.gov reveals that this medical study is currently recruiting participants, with the original posting date being October 19th 2021 and most recent update recorded as November 15th 2022. 164 patients are needed to be enrolled from a single site."

Answered by AI