Mediterranean Diet Versus Hypocaloric Diet in PCOS

• ClinicalTrials.gov Identifier: NCT02397174
• Recruitment Status: Unknown
• First Posted: March 24, 2015
• Last Update Posted: April 19, 2016
• Sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Collaborators: Federico II University; University of Modena and Reggio Emilia
• Information provided by (Responsible Party): Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Tracking Information

• First Submitted Date: March 6, 2015
• First Posted Date: March 24, 2015
• Last Update Posted Date: April 19, 2016
• Study Start Date: June 2015
• Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 18, 2015): improvement in insulin resistance measured by HOMA index [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 18, 2015)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mediterranean Diet Versus Hypocaloric Diet in PCOS
• Official Title: Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?
• Brief Summary: 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.

Detailed Description

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Polycystic Ovary Syndrome

Intervention

• Other: mediterranean diet, restricted calorie
  50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
• Other: hypocaloric diet, restricted calorie
  50 pcos women will be assigned to standardized hypocaloric diet for 6 months

Study Arms

• 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.
  Intervention: Other: mediterranean diet, restricted calorie
• 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.
  Intervention: Other: hypocaloric diet, restricted calorie

Publications *

• 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. Epub 2007 Dec 23.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 18, 2015): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2017
• Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02397174
• Other Study ID Numbers: DIEMED1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Study Sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Collaborators

• Federico II University
• University of Modena and Reggio Emilia

Investigators

• Principal Investigator: Francesco Orio, MD; Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

• PRS Account: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Verification Date: April 2016