Time Restricted Eating for Polycystic Ovary Syndrome

Overseen By Krista Varady, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Oral contraceptives, Weight loss, Insulin-sensitizing, Antipsychotic

Disqualifiers: Diabetes, Mood disorders, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different eating strategies to assist women with polycystic ovary syndrome (PCOS), a condition that can lead to fertility issues and other health problems. Participants will follow either a time-restricted eating (TRE) plan, eating freely only between 1:00 pm and 7:00 pm, or a daily calorie restriction (CR) plan, reducing calories by 25%. A control group will maintain their usual eating habits. Women with PCOS who are overweight or obese may be suitable for this study. As an unphased trial, this study provides a unique opportunity to investigate innovative eating strategies that could enhance health and well-being.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications that affect the study outcomes, such as oral contraceptives, weight loss drugs, insulin-sensitizing agents, androgen antagonists, anti-seizure, or antipsychotic medications, at least 2 months before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating (TRE) is generally safe and easy to follow. Studies have found that eating within an eight-hour window can improve health and reduce insulin resistance in women with PCOS, allowing them to try this eating pattern safely without major side effects.

Calorie restriction (CR), which involves eating 25% fewer calories each day, is also a common and safe method for weight loss. Research indicates that CR can help improve PCOS symptoms by supporting long-term weight loss. Both TRE and CR have been extensively studied and are considered safe for managing weight and PCOS symptoms. Participants in these studies did not report significant negative effects, demonstrating that both methods are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about time-restricted eating (TRE) and calorie restriction (CR) for managing Polycystic Ovary Syndrome (PCOS) because these approaches offer a fresh take on dietary interventions. Unlike traditional treatments involving medications like hormonal birth control or metformin, TRE involves an 18-hour daily fasting period, which may improve metabolic health by aligning eating patterns with circadian rhythms. Meanwhile, calorie restriction focuses on a daily 25% reduction in energy intake, which could help with weight management and insulin sensitivity. These methods are non-pharmacological, potentially minimizing side effects associated with drugs, and they empower individuals with PCOS to manage their condition through lifestyle changes.

What evidence suggests that this trial's treatments could be effective for PCOS?

This trial will compare different dietary approaches for managing symptoms of polycystic ovary syndrome (PCOS). Research has shown that time-restricted eating (TRE), one of the approaches tested in this trial, can help manage PCOS symptoms. Specifically, studies have found that an 8-hour TRE plan can significantly lower body mass index (BMI) and the waist-to-hip ratio in women with PCOS. It also helps control blood sugar levels, which is crucial for managing PCOS. Another approach in this trial is calorie restriction (CR), known to aid in weight loss, improve insulin resistance, and regulate menstrual cycles in women with PCOS. Both methods show promise for improving symptoms, but TRE might be easier to follow since it doesn't involve counting calories. ^{1 3 5 6 7}

Who Is on the Research Team?

Krista Varady, PhD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with PCOS using specific guidelines called the Rotterdam criteria.

My BMI is between 25 and 50.

Exclusion Criteria

Your weight has changed by more than 4 kilograms in the past 3 months.

Pregnant or trying to become pregnant

I haven't taken any medication in the last 2 months that could affect the study's results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to 6-hour TRE, CR, or control group for 6 months

6 months

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calorie Restriction
• Control
• Time Restricted Eating

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 Intervention

Usual diet, eating over \>10 h per day

Group II: Calorie restriction (CR) Experimental Treatment 1 Intervention

25% energy restriction every day

Group III: 6-hour Time restricted eating (TRE) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554142/

Time-restricted eating plus calorie-restricted diet versus ... Related studies have shown that lifestyle intervention can improve weight, menstrual cycle, IR, hyperandrogenism, and fertility in women with ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550413125000142

Caloric restriction prevents inheritance of polycystic ovary ... Caloric restriction (CR) prevents the transmission of PCOS-like traits via oocytes. Disrupted DNA methylation in oocytes and offspring tissues is restored by ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11026672/

Effect of calorie restriction and intermittent fasting on glucose ... The implementation of IF has been shown to have the potential to reduce adiposity and improve IR through decreased calorie intake and metabolic ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05629858

Time Restricted Eating for the Treatment of PCOS To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/rmb2.12607

The impact of dietary interventions on polycystic ovary ... There is ample evidence supporting the effectiveness of energy-restricted diets in improving insulin levels in overweight or obese patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8898097/

Weight Management in Adolescents with Polycystic Ovary ... (1) A consistently observed finding is that PCOS outcomes are improved by caloric restriction targeting weight loss among those with excess weight, and weight ...

7. mdpi.com mdpi.com/2072-6643/15/3/556

Effects of a Dulaglutide plus Calorie-Restricted Diet versus ... A calorie-restricted diet (CRD) seems to be the optimal dietary pattern for weight management in the PCOS population, which could reduce body weight, improve ...