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

NCT05196568 | Unknown

• 1 other identifier: VERBALE N° 56
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

• Restoration of menstrual regularity

  The main parameter that will be taken into consideration as an improvement of the syndrome is the restoration of the menstrual cycle, which is not regular in the woman with polycystic ovary syndrome

  End of the treatment (three months)

Secondary Outcomes (7)

• Improvement of blood glucose values (mg / dl)

  End of the treatment (three months)

• Improvement of blood insulinemic values (µU/mL)

  End of the treatment (three months)

• Improvement of blood glycated hemoglobin (%)

  End of the treatment (three months)

• Improvement of blood LDL, HDL, total cholesterol and triglycerides (mg/dl)

  End of the treatment (three months)

• Improvement in plasma sexual hormones

  End of the treatment (three months)

Study Arms (2)

patients not treated with the mimic fasting diet

NO INTERVENTION

Group treated with the mimic fasting diet

patients treated with the mimic fasting diet

EXPERIMENTAL

Group treated with the mimic fasting diet

Dietary Supplement: Fasting mimicking diet

Interventions

Fasting mimicking diet DIETARY_SUPPLEMENT

Women will be given three administrations of fasting mimicking diet once a month

patients treated with the mimic fasting diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female 18-40 years
• BMI 20-40
• Reproductive age women with PCOS diagnosis
• Irregular menstrual cycles
• Chronic oligo/anovulation defined as an intermenstrual interval of \>45 days
• \< 8 menstrual cycles/year
• evidence of either hyperandrogenemia (elevation of total or free testosterone above the normal range for women)
• clinical hyerandrogenism (hirsutism and or acne)
• years from menarche
• Agree to avoidance of pregnancy and to use barrier contraception for duration of study

You may not qualify if:

• Clinically ascertained presence of type I and type II Diabetes
• Pregnancy and/or nursing
• Use of medications and/or supplements that influence either ovarian function or insulin sensitivity, within 2 months: including oral contraceptive pills, hormonal implants, anti-androgens, antipsychotics or antihypertensives metformin, glucocorticoids, and/or health food remedies other than multi-vitamins and calcium;
• Subjects who are on oral contraception, metformin, or nutritional supplements must agree to discontinue these drugs and undergo an 8 week washout period before the tests are performed
• Other drugs that cannot be suspended during the FMD phase
• Alcohol usage more than 7 drinks/week

Sponsors & Collaborators

• University of Salento: lead

Study Sites (1)

Anna Maria Giudetti

Lecce, 73100, Italy

Location

Related Publications (21)

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  PMID: 16219521 BACKGROUND

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  PMID: 23382817 BACKGROUND

• Legro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999 Jan;84(1):165-9. doi: 10.1210/jcem.84.1.5393.

  PMID: 9920077 BACKGROUND

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  PMID: 19223518 BACKGROUND

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  PMID: 15184695 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Anna M Giudetti

  University of Salento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 19, 2022
• Study Start: July 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)