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Completed

NCT Number: NCT05629858

Time Restricted Eating for the Treatment of 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).

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Calorie restriction (CR)

Other

25% energy restriction every day

Control

Other

Usual diet, eating over >10 h per day

Primary outcomes

  1. Change in percent body weight

    Time frame: Measured at month 0 and 6

    Measured by an electronic scale

Secondary outcomes

  1. Change in fat mass, lean mass, visceral fat mass

    Time frame: Measured at month 0 and 6

    Measured by DXA

  2. Change in waist circumference

    Time frame: Measured at month 0 and 6

    Measured by a measuring tape

  3. Change in insulin resistance

    Time frame: Measured at month 0 and 6

    Measured by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)

  4. Change in insulin sensitivity

    Time frame: Measured at month 0 and 6

    Measured by QUICKI (Quantitative insulin sensitivity check index)

  5. Change in fasting glucose

    Time frame: Measured at month 0 and 6

    Measured by a commercial lab (Medstar, IL)

  6. Change in fasting insulin

    Time frame: Measured at month 0 and 6

    Measured by a commercial lab (Medstar, IL)

  7. Change in HbA1c

    Time frame: Measured at month 0 and 6

    Measured by a commercial lab (Medstar, IL)

  8. Change in blood pressure

    Time frame: Measured at month 0 and 6

    Measured by a blood pressure cuff

  9. Change in heart rate

    Time frame: Measured at month 0 and 6

    Measured by a blood pressure cuff

  10. Change in plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)

    Time frame: Measured at month 0 and 6

    Measured by a commercial lab (Medstar, IL)

  11. Change in reproductive hormones (testosterone, DHEA, SHBG)

    Time frame: Measured at month 0 and 6

    Measured by a commercial lab (Medstar, IL)

  12. Change in free androgen index (FAI)

    Time frame: Measured at month 0 and 6

    FAI is calculated by multiplying total testosterone by 100 and dividing by sex hormone binding globulin (SHBG)

  13. Change in energy and nutrient intake

    Time frame: Measured at month 0 and 6

    Measured by 7-day food record

  14. Change in dietary adherence

    Time frame: Measured at month 0 and 6

    Measured by survey

  15. Change in physical activity (steps/d)

    Time frame: Measured at month 0 and 6

    Measured by pedometer

  16. Change in PCOS symptoms

    Time frame: Measured at month 0 and 6

    Measured by a validated questionnaire (PMSIS: Premenstrual symptom impact survey)

  17. Change in hirsutism

    Time frame: Measured at month 0 and 6

    Measured by a validated questionnaire (mFG: modified Ferriman-Gallwey hirsutism scale)

  18. Change in acne severity

    Time frame: Measured at month 0 and 6

    Measured by a validated questionnaire (CASS: Comprehensive acne severity scale)

  19. Change in seborrhea

    Time frame: Measured at month 0 and 6

    Measured by clinical assessment

  20. Change in menstrual regularity and blood loss

    Time frame: Measured at month 0 and 6

    Measured by survey (PBAC: Pictorial blood loss assessment chart)

  21. Occurences of adverse events

    Time frame: Measured at month 0 and 6

    Measured by adverse event survey

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2022
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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