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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
Must not have
Diagnosed type 1 diabetes or type 2 diabetes
Taking drugs that affect study outcomes, such as oral contraceptives, weight loss, insulin-sensitizing agents, androgen antagonists, anti-seizure, or antipsychotic medication (within 2 months of starting study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at month 0 and 6
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with diabetes.
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I haven't taken any medication in the last 2 months that could affect the study's results.
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I have not had a menstrual period for more than 2 years.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in body weight
Secondary study objectives
Change in Blood pressure
Change in Fasting glucose
Change in Fasting insulin
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,486 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
87 Patients Enrolled for Polycystic Ovary Syndrome
Krista Varady, PhDPrincipal InvestigatorUniversity of Illinois Chicago
5 Previous Clinical Trials
361 Total Patients Enrolled

Media Library

Calorie Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05629858 — N/A
Polycystic Ovary Syndrome Research Study Groups: Control, 6-hour Time restricted eating (TRE), Calorie restriction (CR)
Polycystic Ovary Syndrome 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
~183 spots leftby Jan 2028
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