Time Restricted Eating for the Treatment of PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Obesity; Overweight
• Interventions: Other: Control; Other: 6-h Time restricted eating (TRE); Other: Calorie restriction (CR)

• Registration Number: NCT05629858
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-01-15
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Usual diet
6-hour Time restricted eating (TRE)	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)
Calorie restriction (CR)	Calorie restriction (CR)	25% energy restriction every day

Primary Outcome Measures

Name	Time	Method
Change in percent body weight	Measured at month 0 and 6	Measured by an electronic scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States