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Time Restricted Eating for Polycystic Ovary Syndrome

N/A

Waitlist Available

Led By Krista Varady, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

Age between 18-40 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at month 0 and 6

Awards & highlights

Study Summary

This trial will compare the effects of TRE vs CR on body weight, androgen markers, inflammatory markers and insulin sensitivity in women with PCOS.

Who is the study for?

This trial is for women aged 18-40 with obesity and PCOS, diagnosed by the Rotterdam criteria. Participants should have a BMI between 25-50 kg/m2 and not be postmenopausal or have diabetes, eating disorders, or recent use of certain medications that affect weight and hormones. Smokers, pregnant women, high-intensity athletes, and those without Wi-Fi are excluded.Check my eligibility

What is being tested?

The study compares three approaches over six months: (1) Time Restricted Eating (TRE), where participants eat freely from 1 pm to 7 pm but fast at other times; (2) Calorie Restriction (CR), reducing daily calorie intake by 25%; and (3) no specific diet control. It aims to see which method best improves body weight, hormonal balance, inflammation levels, and insulin sensitivity in PCOS.See study design

What are the potential side effects?

Potential side effects may include hunger during fasting periods for TRE group members or feelings of restriction/fatigue due to reduced calorie intake in the CR group. The control group might not experience these issues as there are no dietary changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at month 0 and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at month 0 and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at month 0 and 6 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 weight

Secondary outcome measures

Change in Blood pressure

Change in Fasting glucose

Change in Fasting insulin

+14 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: ControlExperimental Treatment1 Intervention

Usual diet

Group II: Calorie restriction (CR)Experimental Treatment1 Intervention

25% energy restriction every day

Group III: 6-hour Time restricted eating (TRE)Experimental Treatment1 Intervention

Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

607 Previous Clinical Trials

1,559,055 Total Patients Enrolled

33 Trials studying Obesity

9,523 Patients Enrolled for Obesity

Krista Varady, PhDPrincipal InvestigatorUniversity of Illinois Chicago

5 Previous Clinical Trials

361 Total Patients Enrolled

4 Trials studying Obesity

330 Patients Enrolled for Obesity

Media Library

Calorie Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05629858 — N/A

Obesity Research Study Groups: Control, 6-hour Time restricted eating (TRE), Calorie restriction (CR)

Obesity Clinical Trial 2023: Calorie Restriction Highlights & Side Effects. Trial Name: NCT05629858 — N/A

Calorie Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05629858 — N/A

Frequently Asked Questions

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

Is participation in this trial open to me?

"This clinical trial is recruiting 300 participants, aged between 18 and 40 years old with obesity. To qualify, patients must have polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria which states two of three symptoms need to be present: 1.) excessive hair growth, acne or seborrhea; 2.) multiple cysts on an ultrasound exam; 3.) irregular menstrual cycles or fewer than seven periods a year. In addition, their body mass index should range from 25-50 kg/m2."

Answered by AI

Is enrollment open in this experiment?

"Contrary to what is indicated on clinicaltrials.gov, this medical trial isn't presently seeking patient enrolment. The initial posting was made in January of 2023 and the last update happened back in November 2022. However, there are 2,362 additional trials currently recruiting participants."

Answered by AI

Do patients of an octogenarian age qualify for this experiment?

"The requirements for participation in this trial dictate that enrollees are aged between 18 and 40 years old. For those who do not meet these age criteria, there exist 585 studies geared towards minors and 1573 trials adapted to the elderly population."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Time Restricted Eating for the Treatment of PCOS

Krista Varady 2023. "Time Restricted Eating for the Treatment of PCOS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05629858.

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