NCT05196568

Effects of Fasting Mimicking Diet (FMD) in Women With Polycystic Ovary Syndrome (PCOS)

Status unknown NA Last updated 5 December 2023

What this trial tests

NA trial testing Fasting mimicking diet in Polycystic Ovarian Syndrome in 100 participants. Status unknown.

Timeline

1 July 2021

Primary endpoint
1 January 2024

1 January 2025

Quick facts

Lead sponsor	University of Salento
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 July 2021
Primary completion	1 January 2024
Estimated completion	1 January 2025
Sites	1 location across Italy

Drugs / interventions tested

• Fasting mimicking diet

Conditions studied

• Polycystic Ovarian Syndrome — all drugs for Polycystic Ovarian Syndrome →

Sponsor

University of Salento

Who can join

Adults 18 to 40, female only, with Polycystic Ovarian Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in reproductive-aged women, affecting 6-21% (depending on the applied diagnostic criteria) of this population worldwide. PCOS is characterized by hyperandrogenism and/or chronic anovulation which can manifest with a range of symptoms (e.g., hirsutism, acne, oligomenorrhea, and infertility) and is associated with increased risk of cardiometabolic diseases, including hypertension, dyslipidemia, insulin resistance (IR), and type 2 diabetes mellitus (T2DM). Moreover, PCOS is linked to increased psychological morbidity (e.g., increased risk of stress, depression, low self-esteem, and poor body image). The exact PCOS etiology is unknown, but increased adiposity is considered pivotal. Indeed, almost 90% of women with PCOS are overweight or obese, and even moderate weight loss may result in clinically meaningful improvements in hyperandrogenism and menstrual regularity. Also, women with PCOS often have more severe IR than weight-matched women without PCOS, whilst their increased susceptibility to obesity may further exacerbate IR and the accompanying metabolic and reproductive dysfunctions. As such, women with PCOS exhibit an increased risk of impaired glucose tolerance and T2DM regardless of weight and age. Management of overweight/obese women with PCOS focuses on weight loss through regular exercise and diet, aiming to alleviate its clinical manifestations and lower the related risk of T2DM and cardiovascular disease. Fasting-induced negative energy also potently affects the hormones such as estradiol, testosterone, and leptin, and complex interactions exist between metabolic signals and ovarian steroids. However, fasting is difficult to implement. It is of great interest to develop feasible and efficacious fasting-mimicking diets (FMD) to alleviate the burden of fasting while preserving the beneficial effects of fasting. In a case study, the investigators observed that a 23-year-old female diagnosed with PCOS had her persistent cystic acne resolved after just 3 cycles of self-administered fasting-mimicking dieting. In addition, FDM induces a reduction in insulin levels, fasting glucose, BMI, decreased adiposity, and inflammation rates. The investigators hypothesize that a specially designed FMD will induce physiological changes similar to prolonged fasting and will decrease risk factors associated with metabolic syndrome and alleviate symptoms of PCOS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.