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 greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS.

Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity.

Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• 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

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; and (iii) chronic oligo-amenorrhea (intermenstrual intervals >35 days or 7 periods/year)
• BMI between 25-50 kg/m2
• Age between 18-40 years

Exclusion criteria:

• Postmenopausal (absence of menses for >2 y)
• Diagnosed type 1 diabetes or type 2 diabetes
• 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 (weight gain or loss > 4 kg)
• 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 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	Other: Control; Usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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 bone mineral density	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 Insulin sensitivity	Measured by oral glucose tolerance test (OGTT)	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 HbA1c	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 heart rate	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 inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP)	Measured by ELISA	Measured at month 0 and 6
Change in oxidative stress (8-isoprostane)	Measured by ELISA	Measured at month 0 and 6
Change in reproductive hormones (testosterone, DHEA, SHBG, androstenedione)	Measured by ELISA	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 mood	Measured by 36-Item Short Form Survey (SF-36), total score 0-100. Higher scores mean worse outcome.	Measured at month 0 and 6
Change in appetite	Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.	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 (Anticipated): January 1, 2028
• Study Completion (Anticipated): January 1, 2028

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): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; 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