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Polycystic Ovary SyndromeNCT05629858

Time Restricted Eating for the Treatment of PCOS

A study testing 6-h Time restricted eating (TRE) and Calorie restriction (CR) in people with Polycystic Ovary Syndrome and Obesity, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome, Obesity, Overweight
What is being tested?
6-h Time restricted eating (TRE) and Calorie restriction (CR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
15 Jan 2023to 15 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Time Restricted Eating for the Treatment of Polycystic Ovarian Syndrome (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.

Read more

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).

Being tested
6-h Time restricted eating (TRE), Calorie restriction (CR), Control
Medical subject headings
Polycystic Ovary Syndrome, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • ControlOther

    Usual diet, eating over >10 h per day

Study groups in NCT05629858
Study groupRoleWhat they receive
6-hour Time restricted eating (TRE)ExperimentalAd libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)
Receives: Other: 6-h Time restricted eating (TRE)
Calorie restriction (CR)Experimental25% energy restriction every day
Receives: Other: Calorie restriction (CR)
ControlExperimentalUsual diet, eating over >10 h per day
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in percent body weight

    Measured by an electronic scale

    Measured: Measured at month 0 and 6

Secondary outcomes (21)

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

    Measured by DXA

    Measured: Measured at month 0 and 6

  2. Change in waist circumference

    Measured by a measuring tape

    Measured: Measured at month 0 and 6

  3. Change in insulin resistance

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

    Measured: Measured at month 0 and 6

  4. Change in insulin sensitivity

    Measured by QUICKI (Quantitative insulin sensitivity check index)

    Measured: Measured at month 0 and 6

  5. Change in fasting glucose

    Measured by a commercial lab (Medstar, IL)

    Measured: Measured at month 0 and 6

  6. Change in fasting insulin

    Measured by a commercial lab (Medstar, IL)

    Measured: Measured at month 0 and 6

  7. Change in HbA1c

    Measured by a commercial lab (Medstar, IL)

    Measured: Measured at month 0 and 6

  8. Change in blood pressure

    Measured by a blood pressure cuff

    Measured: Measured at month 0 and 6

  9. Change in heart rate

    Measured by a blood pressure cuff

    Measured: Measured at month 0 and 6

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

    Measured by a commercial lab (Medstar, IL)

    Measured: Measured at month 0 and 6

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

    Measured by a commercial lab (Medstar, IL)

    Measured: Measured at month 0 and 6

  12. Change in free androgen index (FAI)

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

    Measured: Measured at month 0 and 6

  13. Change in energy and nutrient intake

    Measured by 7-day food record

    Measured: Measured at month 0 and 6

  14. Change in dietary adherence

    Measured by survey

    Measured: Measured at month 0 and 6

  15. Change in physical activity (steps/d)

    Measured by pedometer

    Measured: Measured at month 0 and 6

  16. Change in PCOS symptoms

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

    Measured: Measured at month 0 and 6

  17. Change in hirsutism

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

    Measured: Measured at month 0 and 6

  18. Change in acne severity

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

    Measured: Measured at month 0 and 6

  19. Change in seborrhea

    Measured by clinical assessment

    Measured: Measured at month 0 and 6

  20. Change in menstrual regularity and blood loss

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

    Measured: Measured at month 0 and 6

  21. Occurences of adverse events

    Measured by adverse event survey

    Measured: Measured at month 0 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start15 Jan 2023
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05629858
Sponsor's protocol ID
2022-1500
Status last verified
Mar 2025
First submitted
17 Nov 2022
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Corapi S, Runchey MC, Lyons J, Alonso de Leon M, Pavlou V, Lin S, Ezpeleta M, Gabel K, Tussing-Humphreys L, Oddo VM, Alexandria SJ, Sanchez J, Vidmar AP, Varady KA, Cienfuegos S. Time-restricted eating for body weight management in women with polycystic ovary syndrome: a randomized controlled trial. Nat Med. 2026 Jun;32(6):2155-2163. doi: 10.1038/s41591-026-04316-7. Epub 2026 Mar 27.

    PubMed 41896647

Questions about this trial

What is this clinical trial studying?

A study testing 6-h Time restricted eating (TRE) and Calorie restriction (CR) in people with Polycystic Ovary Syndrome and Obesity, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percent body weight (time frame: Measured at month 0 and 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05629858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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