Time Restricted Eating for the Treatment of PCOS

Trial Title: Time Restricted Eating for the Treatment of PCOS

NCT ID: NCT05629858

Condition: Polycystic Ovary Syndrome
Obesity

Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: 6-h Time restricted eating (TRE)
Description: Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)
Arm group label: 6-hour Time restricted eating (TRE)

Intervention type: Other
Intervention name: Calorie restriction (CR)
Description: 25% energy restriction every day
Arm group label: Calorie restriction (CR)

Intervention type: Other
Intervention name: Control
Description: Usual diet
Arm group label: Control

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 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).

Criteria for 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; 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

Gender: Female

Gender based: Yes

Gender description: Women with PCOS will be invited to participate in the study.

Minimum age: 18 Years

Maximum age: 40 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Illinois Chicago

Address:
City: Chicago
Zip: 60612
Country: United States

Start date: January 15, 2023

Completion date: January 1, 2028

Lead sponsor:
Agency: University of Illinois at Chicago
Agency class: Other

Source: University of Illinois at Chicago

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05629858