Mediterranean Diet Versus Hypocaloric Diet in PCOS
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| ClinicalTrials.gov Identifier: NCT02397174 |
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Recruitment Status : Unknown
Verified April 2016 by Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona.
Recruitment status was: Recruiting
First Posted : March 24, 2015
Last Update Posted : April 19, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycystic Ovary Syndrome | Other: mediterranean diet, restricted calorie Other: hypocaloric diet, restricted calorie | Not Applicable |
PCOS is the most common endocrine disorder of reproductive age women, that is often associated with chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. The new guidelines for the management of metabolic risk in PCOS strongly recommended that overweight/obese women with PCOS should lose weight changing their lifestyle. Although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested.
In this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)? |
| Study Start Date : | June 2015 |
| Estimated Primary Completion Date : | March 2017 |
| Estimated Study Completion Date : | June 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Mediterranean Diet
The diet programme will be characterized by carbohydrates (60 %); proteins (20 %, half comprised of vegetable proteins); total fat (20 %; saturated fat < 10 %). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day.
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Other: mediterranean diet, restricted calorie
50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months |
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Active Comparator: hypocaloric diet
The diet programme will be characterized by carbohydrates (50%),total lipids (30%) and proteins (20%). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day.
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Other: hypocaloric diet, restricted calorie
50 pcos women will be assigned to standardized hypocaloric diet for 6 months |
- improvement in insulin resistance measured by HOMA index [ Time Frame: 6 months ]
- composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio); [ Time Frame: 6 months ]
- composite improvement in metabolic parameters (total, LDL and HDL cholesterol); [ Time Frame: 6 months ]
- composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol) [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria)
- BMI > 25
Exclusion Criteria:
- Age <18 or >35 years
- BMI higher than 35
- Pregnancy
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months
- Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397174
| Contact: Francesco Orio, MD | +39 338 6759977 | francescoorio@virgilio.it |
| Italy | |
| Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona | Recruiting |
| Salerno, Italy, 84131 | |
| Contact: Francesco Orio, MD +39 338 6759977 francescoorio@virgilio.it | |
| Principal Investigator: | Francesco Orio, MD | Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona |
| Responsible Party: | Francesco Orio, prof, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona |
| ClinicalTrials.gov Identifier: | NCT02397174 |
| Other Study ID Numbers: |
DIEMED1 |
| First Posted: | March 24, 2015 Key Record Dates |
| Last Update Posted: | April 19, 2016 |
| Last Verified: | April 2016 |
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Polycystic Ovary syndrome hypocaloric diet Ovarian Cysts |
Ovarian Diseases Obesity Mediterranean Diet |
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Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |