The Effect of Time-restricted Eating on Insulin Levels and Other Metabolic Abnormalities in Polycystic Ovarian Syndrome: A Randomised Feasibility Study of Real-world Clinical Advice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Drop-out rate
Study Overview
Brief Summary
Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.
Detailed Description
Background: Polycystic ovarian syndrome (PCOS) is the most common reproductive endocrinopathy in women of reproductive age with many associated metabolic symptoms, in particular hyperinsulinemia, insulin resistance and a high lifetime risk of type 2 diabetes mellitus. The effects of time-restricted eating on metabolic profiles have been investigated in many endocrinopathies, but there are minimal data in PCOS.
Methods: This study will investigate the feasibility of time-restricted eating in the management of PCOS, and its effects on insulin levels and other metabolic parameters.
To achieve this, the investigators will recruit 20 patients with PCOS (normal weight, overweight, obese).
In a randomised cross-over design, participants will be observed for two consecutive 12 week periods (with a 4 weeks washout period in between) following either 'time-restricted eating' or 'usual eating', detailed below.
- 18:6 protocol: 18 hours of fasting and a 6-hours eating window, with no other specific dietary advice. Participants choose their own 6-hour period according to their lifestyle and preference.
- Usual eating: follow usual eating patterns, no time restriction, no other dietary advice
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult women of reproductive age with confirmed diagnosis of PCOS (Rotterdam Criteria, including at least 2 of 3 characteristics: oligomenorrhea, clinical and/or biochemical hyperandrogenism and ultrasound criteria)
- •No BMI restriction
- •Able and willing to provide explicit, informed consent
Exclusion Criteria
- •Type 1 diabetes, medication-controlled type 2 diabetes
- •Pregnancy
- •Currently participating in weight loss programme, or reported weight change in last 3 months (>5% of current body weight)
- •Documented history of eating disorder
- •Ovulation medication, such as clomiphene citrate
- •Weight loss medication affecting weight or appetite in last 6 months, including weight loss medications, antipsychotic drugs or other medications as determine by the physician (eg. Semaglutide, liraglutide, orlistat, amphetamines, Qsymia (phentermine-topiramate), bupropion-naltrexone (Contrave))
- •Known liver, renal or thyroid dysfunction (not including non-alcoholic fatty liver disease with hypothyroidism on treatment or subclinical hypothyroidism seen in a large proportion of patients with PCOS)
- •Unable to participate in follow-up for at least 24 weeks
- •Unable or unwilling to provide explicit, informed consent
Outcomes
Primary Outcomes
Drop-out rate
Time Frame: 12 weeks
Assessing intervention feasibility
Adverse outcomes as assessed by CTCAE v4.0
Time Frame: 12 weeks
Assessing intervention feasibility
Change in food diaries
Time Frame: 12 weeks
Assessment of change of eating behaviours
Change in serum insulin
Time Frame: 12 weeks
Measured with serum insulin levels to assess effects
Secondary Outcomes
- Change in insulin resistance(12 weeks)
- Change in markers of hunger(12 weeks)
- Change in testosterone levels(12 weeks)
- Change in HbA1c(12 weeks)
- Change in dehydroepiandrosterone sulfate (DHEA-S) levels(12 weeks)
- Change in androstenedione levels(12 weeks)
- Change in 17-Hydroxyprogesterone (17-OHP) levels(12 weeks)
- Change in body weight(12 weeks)
- Change in body mass index(12 weeks)
- Change in dietary intake(12 weeks)
- Change in free testosterone levels(12 weeks)
- Change in sex hormone binding globulin (SHBG) levels(12 weeks)
- Change in fasting glucose(12 weeks)
- Change in anthropometric measurements (waist-hip ratio)(12 weeks)
- Change in appetite(12 weeks)
- Change in anthropometric measurements (waist circumference)(12 weeks)
- Change in lipids(12 weeks)
- Change in markers of satiety(12 weeks)
Investigators
Ruairí Floyd
Study Co-ordinator and Researcher
Tallaght University Hospital