Time Restricted Eating for the Treatment of PCOS

NCT ID: NCT05629858

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-12-15

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).

Conditions

Polycystic Ovary Syndrome; Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

6-h Time restricted eating (TRE)

Intervention Type: OTHER

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

Calorie restriction (CR)

25% energy restriction every day

Group Type: EXPERIMENTAL

Calorie restriction (CR)

Intervention Type: OTHER

25% energy restriction every day

Control

Usual diet, eating over \>10 h per day

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

Usual diet, eating over \>10 h per day

Interventions

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)

Intervention Type: OTHER

Calorie restriction (CR)

25% energy restriction every day

Intervention Type: OTHER

Control

Usual diet, eating over \>10 h per day

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Krista Varady

Professor of Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krista Varady, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2022-1500

Identifier Type: -

Identifier Source: org_study_id