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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    100
  • sponsor
    University of Salento
Updated on 22 March 2022
diabetes
insulin
metabolic syndrome
fasting
type 2 diabetes mellitus
impaired glucose tolerance
insulin resistance
acne
testosterone
testosterone level
infertility
estradiol
oligomenorrhea
anovulatory
hyperandrogenism
anovulation
hirsutism
Accepts healthy volunteers

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.

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, poor body image, and reduced health-related quality of life). 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 (e.g., 5%) 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, 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.

The purpose of the study is to evaluate the effect of FMD in women with PCOS. Regarding the study model, a crossover will be applied. Our crossover design is the simplest model known as 2 x 2 where two treatments are compared in two-period, two-sequence model. Each washout, between consecutive periods, is done so that the previous treatment does not affect the response to the next treatment. The main advantage of a crossover design over the parallel group is the opportunity it offers to compare the effects of treatments within-subjects, which is not possible with a conventional parallel-group design. Additionally, a crossover design usually requires a smaller sample size to reliably estimate the magnitude of the treatment effect. That is, any component of an individual's response that is consistent over time is removed from the treatment comparison. Study participants will be randomized and assigned to arm 1 (n° = 50, control patients) or arm 2 (n° = 50, patients undergoing FMD). Patients in the FMD group will be asked to consume FMD, which will be provided with a box, for 5 continuous days, and to return to their normal diet after completion until the next cycle which will start 25 days later, for a total of three months.

The two groups will then be exchanged in the third month so that the control group will also be subjected to FMD in the following three months.

The main parameters that will be texted, are all major symptoms associated with PCOS, including menstrual cycle regularity, ovarian morphology (by ultrasound); hirsutism (by the Ferriman-Gallwey (FG) scoring method), and acne score. Moreover, improvement in metabolic, inflammatory, and psychological markers will be also evaluated.

Both control and FMD patients will complete anthropometric measurements every month (at the end of each FMD cycle). After three months, patients will be crossed for another 3 months: patients with arm 1 control will be instructed to follow FMD, while patients with arm 2 undergoing FMD will be asked to continue their normal diet. Follow-up exams will be conducted for both groups at the end of the 6th month. Thereafter, all patients will be asked to continue their normal diet for another three months and will undergo further follow-up at the end of the ninth month. Blood chemistry analyzes will be performed at time zero, at 3 and 6 months, while gynecological and nutritional checks will be performed at time zero at 3 to 6 months and at the end of the study (t = 9 months). The total duration of the study is 9 months. The evaluation of the menstrual history and the anthropometric parameters will be measured during the gynecological and nutritional checks. The psychological/psychiatric evaluation will be carried out at T0, at 3 to 6 months, and at 9 months. Blood samples will also be used for IGF-1 analyzes (IFOM, Milan). Both control and FMD patients will fill out a food diary. Patients undergoing FMD will be contacted by phone for nutritional assistance once a day during the 5 days of FMD. Additionally, to assess adherence to the 5-day nutritional plan for FMD, patients will independently assess their ketonuria with appropriate sticks. Every month, all enrolled patients will note the possible date of menstruation and the duration of the cycle.

Details
Condition Polycystic Ovarian Syndrome
Treatment DMD
Clinical Study IdentifierNCT05196568
SponsorUniversity of Salento
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

• Clinically ascertained presence of type I and type II Diabetes
Pregnancy and/or nursing
Medication exclusion
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note