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NCT05629858 · ClinicalTrials.gov registry record · NA
Time Restricted Eating for the Treatment of PCOS
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT05629858 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 76 participants.
The verdict
NCT05629858, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study 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).
Interventions
- OTHER Control
- OTHER 6-h Time restricted eating (TRE)
- OTHER Calorie restriction (CR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2023-01-15 |
| Est. Completion | 2024-12-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05629858
The ClinicalTrials.gov registry entry for NCT05629858 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.
NCT05629858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05629858 about?
NCT05629858 is a clinical study titled "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 l...
What is the current status of trial NCT05629858?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2023-01-15. Estimated completion is 2024-12-15.
What interventions are being tested in trial NCT05629858?
The interventions under investigation include: Control (OTHER), 6-h Time restricted eating (TRE) (OTHER), Calorie restriction (CR) (OTHER).
Who is sponsoring clinical trial NCT05629858?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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