An interventional study of 6-h Time restricted eating (TRE) and Calorie restriction (CR) in Polycystic Ovary Syndrome, Obesity and Overweight, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
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).
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 76 is close to the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
4.2 Exclusion criteria:
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)
25% energy restriction every day
Other: Calorie restriction (CR)
Usual diet, eating over \>10 h per day
Other: Control
Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)
25% energy restriction every day
Usual diet, eating over \>10 h per day
Change in percent body weight
Measured by an electronic scale
Time frame: Measured at month 0 and 6
Change in fat mass, lean mass, visceral fat mass
Measured by DXA
Time frame: Measured at month 0 and 6
Change in waist circumference
Measured by a measuring tape
Time frame: Measured at month 0 and 6
Change in insulin resistance
Measured by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Time frame: Measured at month 0 and 6
Change in insulin sensitivity
Measured by QUICKI (Quantitative insulin sensitivity check index)
Time frame: Measured at month 0 and 6
Change in fasting glucose
Measured by a commercial lab (Medstar, IL)
Time frame: Measured at month 0 and 6
Change in fasting insulin
Measured by a commercial lab (Medstar, IL)
Time frame: Measured at month 0 and 6
Change in HbA1c
Measured by a commercial lab (Medstar, IL)
Time frame: Measured at month 0 and 6
Change in blood pressure
Measured by a blood pressure cuff
Time frame: Measured at month 0 and 6
Change in heart rate
Measured by a blood pressure cuff
Time frame: Measured at month 0 and 6
Change in plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)
Measured by a commercial lab (Medstar, IL)
Time frame: Measured at month 0 and 6
Change in reproductive hormones (testosterone, DHEA, SHBG)
Measured by a commercial lab (Medstar, IL)
Time frame: Measured at month 0 and 6
Change in free androgen index (FAI)
FAI is calculated by multiplying total testosterone by 100 and dividing by sex hormone binding globulin (SHBG)
Time frame: Measured at month 0 and 6
Change in energy and nutrient intake
Measured by 7-day food record
Time frame: Measured at month 0 and 6
Change in dietary adherence
Measured by survey
Time frame: Measured at month 0 and 6
Change in physical activity (steps/d)
Measured by pedometer
Time frame: Measured at month 0 and 6
Change in PCOS symptoms
Measured by a validated questionnaire (PMSIS: Premenstrual symptom impact survey)
Time frame: Measured at month 0 and 6
Change in hirsutism
Measured by a validated questionnaire (mFG: modified Ferriman-Gallwey hirsutism scale)
Time frame: Measured at month 0 and 6
Change in acne severity
Measured by a validated questionnaire (CASS: Comprehensive acne severity scale)
Time frame: Measured at month 0 and 6
Change in seborrhea
Measured by clinical assessment
Time frame: Measured at month 0 and 6
Change in menstrual regularity and blood loss
Measured by survey (PBAC: Pictorial blood loss assessment chart)
Time frame: Measured at month 0 and 6
Occurences of adverse events
Measured by adverse event survey
Time frame: Measured at month 0 and 6
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago