Time Restricted Eating for the Treatment of PCOS

Time Restricted Eating for the Treatment of Polycystic Ovarian Syndrome (PCOS)

BACKGROUND:

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. 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 patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which can increase compliance to these protocols. Recent findings show that TRE significantly reduces body weight and insulin resistance in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS.

OBJECTIVE:

We conducted a 6-month, randomized, controlled trial comparing the effects of 6-h TRE (eating all food between 1:00 pm to 7:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group (eating over a period of 10 or more hours per day), on body weight and PCOS symptoms in a racially-ethnically diverse group of females with PCOS.

METHODS:

A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with overweight/obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (eating all food between 1:00 pm to 7:00 pm, without calorie counting); (2) CR (25% energy restriction daily); or (3) control group (eating over a period of 10 or more hours per day).

Study Overview

• Status: Completed
• Conditions: Obesity; Polycystic Ovary Syndrome; Overweight
• Intervention / Treatment: Other: 6-h Time restricted eating (TRE); Other: Calorie restriction (CR); Other: Control

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

4.1 Inclusion criteria:

• Diagnosed with PCOS based on the Rotterdam criteria in which two of three of the following criteria are present: (i) androgen excess skin manifestations (hirsutism, acne, and seborrhea) and/or hyperandrogenemia (total testosterone >55 pg/ml, free testosterone >9.4 pg/ml, androstenedione >2.1 ng/ml or DHEA-S >340 ug/dl); (ii) polycystic ovarian morphology on ultrasound (ovarian volume >10 cc and /or antral follicle count 20 in at least one ovary); and (iii) chronic oligo-amenorrhea (intermenstrual intervals >35 days or 7 periods/year)
• BMI between 25-50 kg/m2
• Age between 18-45 years

4.2 Exclusion criteria:

• Postmenopausal (absence of menses for >2 y)
• Diagnosed type 1 diabetes or type 2 diabetes
• Previously diagnosed with a mood depressive disorder (by a doctor or psychologist)
• Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
• Are not weight stable for 3 months prior to the beginning of the study
• Are 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)
• Are currently following a TRE protocol
• Are athletes or those engaging in >1 hour of high-intensity training on more than 5 days/week
• Are active smokers (within 3 months of starting the study)
• Do not have a Wi-Fi connection at home (needed for zoom calls)
• Pregnant or trying to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6-hour Time restricted eating (TRE); Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)	Other: 6-h Time restricted eating (TRE); Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)
Experimental: Calorie restriction (CR); 25% energy restriction every day	Other: Calorie restriction (CR); 25% energy restriction every day
Experimental: Control; Usual diet, eating over >10 h per day	Other: Control; Usual diet, eating over >10 h per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent body weight	Measured by an electronic scale	Measured at month 0 and 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fat mass, lean mass, visceral fat mass	Measured by DXA	Measured at month 0 and 6
Change in waist circumference	Measured by a measuring tape	Measured at month 0 and 6
Change in HbA1c	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Change in heart rate	Measured by a blood pressure cuff	Measured at month 0 and 6
Change in energy and nutrient intake	Measured by 7-day food record	Measured at month 0 and 6
Change in physical activity (steps/d)	Measured by pedometer	Measured at month 0 and 6
Change in insulin resistance	Measured by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)	Measured at month 0 and 6
Change in insulin sensitivity	Measured by QUICKI (Quantitative insulin sensitivity check index)	Measured at month 0 and 6
Change in fasting glucose	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Change in fasting insulin	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Change in blood pressure	Measured by a blood pressure cuff	Measured at month 0 and 6
Change in plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Change in reproductive hormones (testosterone, DHEA, SHBG)	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Change in free androgen index (FAI)	FAI is calculated by multiplying total testosterone by 100 and dividing by sex hormone binding globulin (SHBG)	Measured at month 0 and 6
Change in dietary adherence	Measured by survey	Measured at month 0 and 6
Change in PCOS symptoms	Measured by a validated questionnaire (PMSIS: Premenstrual symptom impact survey)	Measured at month 0 and 6
Change in hirsutism	Measured by a validated questionnaire (mFG: modified Ferriman-Gallwey hirsutism scale)	Measured at month 0 and 6
Change in acne severity	Measured by a validated questionnaire (CASS: Comprehensive acne severity scale)	Measured at month 0 and 6
Change in seborrhea	Measured by clinical assessment	Measured at month 0 and 6
Change in menstrual regularity and blood loss	Measured by survey (PBAC: Pictorial blood loss assessment chart)	Measured at month 0 and 6
Occurences of adverse events	Measured by adverse event survey	Measured at month 0 and 6

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Krista Varady, PhD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Nutrition Disorders; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Overweight; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: 2022-1500

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No