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| Name | Class |
|---|---|
| Federico II University | OTHER |
| University of Modena and Reggio Emilia | OTHER |
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Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in PCOS women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet | Experimental | 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. |
|
| hypocaloric diet | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mediterranean diet, restricted calorie | Other | 50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement in insulin resistance measured by HOMA index | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio); | 6 months | |
| composite improvement in metabolic parameters (total, LDL and HDL cholesterol); | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Orio, MD | Contact | +39 338 6759977 | francescoorio@virgilio.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Orio, MD | Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona | Recruiting | Salerno | Salerno | 84131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18158291 | Result | Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23. | |
| 20858697 |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D010048 | Ovarian Cysts |
| D010049 | Ovarian Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| hypocaloric diet, restricted calorie | Other | 50 pcos women will be assigned to standardized hypocaloric diet for 6 months |
|
| composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol) | 6 months |
| Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |