NCT05629858Completed
Time Restricted Eating for the Treatment of PCOS
Time Restricted Eating for the Treatment of Polycystic Ovarian Syndrome (PCOS)
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 17 Nov 2022
- Start date
- 15 Jan 2023
- Primary completion date
- 15 Dec 2024
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Obesity
- NCT number
- NCT05629858
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 15 Jan 2023 to the primary completion date, 15 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.