Time Restricted Eating for the Treatment of PCOS

Obesity Clinical Trial

Official title:

Time Restricted Eating for the Treatment of Polycystic Ovarian Syndrome (PCOS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05629858
• Other study ID #: 2022-1500
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: January 1, 2028

Study information

• Verified date: May 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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)
• Calorie restriction (CR)
25% energy restriction every day
• Control
Usual diet

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Measured by an electronic scale	Measured at month 0 and 6
Secondary	Change in fat mass, lean mass, visceral fat mass	Measured by DXA	Measured at month 0 and 6
Secondary	Change in bone mineral density	Measured by DXA	Measured at month 0 and 6
Secondary	Change in waist circumference	Measured by a measuring tape	Measured at month 0 and 6
Secondary	Change in Insulin sensitivity	Measured by oral glucose tolerance test (OGTT)	Measured at month 0 and 6
Secondary	Change in Fasting glucose	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Secondary	Change in Fasting insulin	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Secondary	Change in HbA1c	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Secondary	Change in Blood pressure	Measured by a blood pressure cuff	Measured at month 0 and 6
Secondary	Change in heart rate	Measured by a blood pressure cuff	Measured at month 0 and 6
Secondary	Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)	Measured by a commercial lab (Medstar, IL)	Measured at month 0 and 6
Secondary	Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP)	Measured by ELISA	Measured at month 0 and 6
Secondary	Change in oxidative stress (8-isoprostane)	Measured by ELISA	Measured at month 0 and 6
Secondary	Change in reproductive hormones (testosterone, DHEA, SHBG, androstenedione)	Measured by ELISA	Measured at month 0 and 6
Secondary	Change in energy and nutrient intake	Measured by 7-day food record	Measured at month 0 and 6
Secondary	Change in physical activity (steps/d)	Measured by pedometer	Measured at month 0 and 6
Secondary	Change in mood	Measured by 36-Item Short Form Survey (SF-36), total score 0-100. Higher scores mean worse outcome.	Measured at month 0 and 6
Secondary	Change in appetite	Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.	Measured at month 0 and 6