PCO-FAST
Research type
Research Study
Full title
The effect of intermittent fasting on metabolic outcomes in women with polycystic ovary syndrome: A pilot interventional study.
IRAS ID
296382
Contact name
Bassel Hamameeh Al Wattar
Contact email
Sponsor organisation
University College London Hospitals Joint Research Office
Duration of Study in the UK
0 years, 8 months, 30 days
Research summary
Polycystic ovary syndrome (PCOS) is a common and heterogeneous endocrine disorder characterized by a combination of hyperandrogenism, menstrual irregularity and polycystic ovarian morphology. Hormonal disturbance is a key feature in women with PCOS with characteristics of high insulin resistance, and hyperandrogenaemiac.
Lifestyle interventions are commonly recommended by most available evidence-based guidelines as the first-line management strategy in women newly diagnosed with PCOS. Intermittent fasting, days could help to improve the perceived metabolic inflexibility and insulin resistance in women with PCOS and restore their hormonal imbalance to regulate ovulation and menstrual cycles.
The proposed study is aimed as a 12 weeks’ prospective open label interventional clinical study to evaluate the effect of a dietary intervention based on intermittent fasting on the metabolic, anthropometric, reproductive, and quality of life outcomes in anovulatory women with polycystic ovary syndrome
The study objectives are:
-To evaluate the changes in metabolic, anthropometric, and reproductive outcomes in anovulatory women with polycystic ovary syndrome following intermittent fasting over a 12 weeks’ period.-To evaluate the participant’s compliance with the intermittent fasting dietary intervention and its impact on their quality of life
We will enrol women of reproductive age (≥18 years) with a BMI of 18-40 kg/m2 diagnosed with polycystic ovary syndrome as per Rotterdam criteria and anovulation confirmed on day 21 Progesterone. Women who are taking anti-obesity or insulin sensitizing medications will be excluded. Women with diabetes mellitus or other chronic illness who cannot follow a fasting dietary intervention will also be excluded.
We will primarly evaluate the changes in participants’ weight and BMI in addition to other secondary anthropometric, metabolic, reproductive, dietary, and quality of life outcomes.
The study is designed as a proof of concept aiming to evaluate the beneficial effects of the lifestyle intervention on the participants anthropometric, metabolic, reproductive, dietary and quality of life outcomes. We aim to include a total of 20 participants enrolled consecutively over 6 months. We will evaluate the change in reported outcome between baseline and end of the study reported as mean difference with 95% confidence intervals for continuous outcomes. We will report on the feasibility of the intervention by reporting on dietary outcomes with natural frequencies and percentages. Where relevant, we will adjust our findings to potential effect modifiers including participants age, BMI, and ethnicity.REC name
Wales REC 2
REC reference
22/WA/0040
Date of REC Opinion
15 Feb 2022
REC opinion
Unfavourable Opinion