Time Restricted Eating for the Treatment of PCOS
Study Details
Study Description
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 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 6-hour Time restricted eating (TRE) 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)
Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)
|
| Experimental: Calorie restriction (CR) 25% energy restriction every day |
Other: Calorie restriction (CR)
25% energy restriction every day
|
| Experimental: Control Usual diet |
Other: Control
Usual diet
|
Outcome Measures
Primary Outcome Measures
- Change in body weight [Measured at month 0 and 6]
Measured by an electronic scale
Secondary Outcome Measures
- Change in fat mass, lean mass, visceral fat mass [Measured at month 0 and 6]
Measured by DXA
- Change in bone mineral density [Measured at month 0 and 6]
Measured by DXA
- Change in waist circumference [Measured at month 0 and 6]
Measured by a measuring tape
- Change in Insulin sensitivity [Measured at month 0 and 6]
Measured by oral glucose tolerance test (OGTT)
- Change in Fasting glucose [Measured at month 0 and 6]
Measured by a commercial lab (Medstar, IL)
- Change in Fasting insulin [Measured at month 0 and 6]
Measured by a commercial lab (Medstar, IL)
- Change in HbA1c [Measured at month 0 and 6]
Measured by a commercial lab (Medstar, IL)
- Change in Blood pressure [Measured at month 0 and 6]
Measured by a blood pressure cuff
- Change in heart rate [Measured at month 0 and 6]
Measured by a blood pressure cuff
- Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides) [Measured at month 0 and 6]
Measured by a commercial lab (Medstar, IL)
- Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP) [Measured at month 0 and 6]
Measured by ELISA
- Change in oxidative stress (8-isoprostane) [Measured at month 0 and 6]
Measured by ELISA
- Change in reproductive hormones (testosterone, DHEA, SHBG, androstenedione) [Measured at month 0 and 6]
Measured by ELISA
- Change in energy and nutrient intake [Measured at month 0 and 6]
Measured by 7-day food record
- Change in physical activity (steps/d) [Measured at month 0 and 6]
Measured by pedometer
- Change in mood [Measured at month 0 and 6]
Measured by 36-Item Short Form Survey (SF-36), total score 0-100. Higher scores mean worse outcome.
- Change in appetite [Measured at month 0 and 6]
Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Krista Varady, PhD, University of Illinois Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-1500