Time Restricted Eating for the Treatment of PCOS

NCT05629858 | Completed

• 1 other identifier: 2022-1500
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in percent body weight

  Measured by an electronic scale

  Measured at month 0 and 6

Secondary Outcomes (21)

• Change in fat mass, lean mass, visceral fat mass

  Measured at month 0 and 6

• Change in waist circumference

  Measured at month 0 and 6

• Change in insulin resistance

  Measured at month 0 and 6

• Change in insulin sensitivity

  Measured at month 0 and 6

• Change in fasting glucose

  Measured at month 0 and 6

Study Arms (3)

6-hour Time restricted eating (TRE)

EXPERIMENTAL

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)

Calorie restriction (CR)

EXPERIMENTAL

25% energy restriction every day

Other: Calorie restriction (CR)

Control

EXPERIMENTAL

Usual diet, eating over \>10 h per day

Other: Control

Interventions

6-h Time restricted eating (TRE) OTHER

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

6-hour Time restricted eating (TRE)

Calorie restriction (CR) OTHER

25% energy restriction every day

Calorie restriction (CR)

Control OTHER

Usual diet, eating over \>10 h per day

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with PCOS and overweight or obesity will be invited to participate in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Overweight

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Krista Varady, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: January 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)