Clinical trial NCT05629858: Time Restricted Eating for the Treatment of PCOS
Official title: Time Restricted Eating for the Treatment of Polycystic Ovarian Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Obesity
Overweight
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in percent body weight
timeFrame: Measured at month 0 and 6
Secondary outcomes:
measure: Change in fat mass, lean mass, visceral fat mass
timeFrame: Measured at month 0 and 6
measure: Change in waist circumference
timeFrame: Measured at month 0 and 6
measure: Change in insulin resistance
timeFrame: Measured at month 0 and 6
measure: Change in insulin sensitivity
timeFrame: Measured at month 0 and 6
measure: Change in fasting glucose
timeFrame: Measured at month 0 and 6
measure: Change in fasting insulin
timeFrame: Measured at month 0 and 6
measure: Change in HbA1c
timeFrame: Measured at month 0 and 6
measure: Change in blood pressure
timeFrame: Measured at month 0 and 6
measure: Change in heart rate
timeFrame: Measured at month 0 and 6
measure: Change in plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)
timeFrame: Measured at month 0 and 6
measure: Change in reproductive hormones (testosterone, DHEA, SHBG)
timeFrame: Measured at month 0 and 6
measure: Change in free androgen index (FAI)
timeFrame: Measured at month 0 and 6
measure: Change in energy and nutrient intake
timeFrame: Measured at month 0 and 6
measure: Change in dietary adherence
timeFrame: Measured at month 0 and 6
measure: Change in physical activity (steps/d)
timeFrame: Measured at month 0 and 6
measure: Change in PCOS symptoms
timeFrame: Measured at month 0 and 6
measure: Change in hirsutism
timeFrame: Measured at month 0 and 6
measure: Change in acne severity
timeFrame: Measured at month 0 and 6
measure: Change in seborrhea
timeFrame: Measured at month 0 and 6
measure: Change in menstrual regularity and blood loss
timeFrame: Measured at month 0 and 6
measure: Occurences of adverse events
timeFrame: Measured at month 0 and 6
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Krista Varady, PhD
role: PRINCIPAL_INVESTIGATOR
References: