Mediterranean Diet as Treatment for Normal Weight Women With PCOS

NCT ID: NCT02396264

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-06-30

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women characterized by 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 standardized normocaloric Diet in normal weight women with PCOS.

Detailed Description

PCOS is the most common endocrine disorder of reproductive age women, that is often characterized by 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. In addition, although insulin resistance is a crucial pathogenetic factor for PCOS and lifestyle change program improves insulin resistance, no available data can also suggest whether non-obese women with PCOS benefit or did not from lifestyle change program including diet without calorie-restriction. Although there are not studies focused on the effectiveness and safety of Mediterranean diet in PCOS, several indirect studies performed in obese and/or insulin resistant subjects, seem to suggest a potential role of this diet in PCOS population and, in particular, on long-term PCOS-related health risk. In this study, the investigators' purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in normal weight women with PCOS.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 mantain the same weight of the time of recruitment

Group Type: EXPERIMENTAL

mediterranean diet

Intervention Type: OTHER

50 pcos women will be assigned to normocaloric mediterranean diet for 6 months

normocaloric diet

50% carbohydrates, 30% total lipids and 20% proteins. After calculating the patient's energy need, the amount of calories will be successively adjusted to mantain the same weight of the time of recruitment

Group Type: ACTIVE_COMPARATOR

normocaloric diet

Intervention Type: OTHER

50 pcos women will be assigned to standardized normocaloric diet for 6 months

Interventions

mediterranean diet

50 pcos women will be assigned to normocaloric mediterranean diet for 6 months

Intervention Type: OTHER

normocaloric diet

50 pcos women will be assigned to standardized normocaloric diet for 6 months

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: collaborator

University of Modena and Reggio Emilia

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

OTHER

Sponsor Role: lead

Responsible Party

Francesco Orio

prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Orio, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Locations

Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Salerno, Salerno, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Orio, MD

Role: CONTACT

francescoorio@virgilio.it

+39 338 6759977

Facility Contacts

Francesco Orio, MD

Role: primary

francescoorio@virgilio.it

+39 338 6759977

References

Orio F, Palomba S. Reproductive endocrinology: New guidelines for the diagnosis and treatment of PCOS. Nat Rev Endocrinol. 2014 Mar;10(3):130-2. doi: 10.1038/nrendo.2013.248. Epub 2013 Dec 10.

Reference Type: RESULT

PMID: 24322653 (View on PubMed)

Boghossian NS, Yeung EH, Mumford SL, Zhang C, Gaskins AJ, Wactawski-Wende J, Schisterman EF; BioCycle Study Group. Adherence to the Mediterranean diet and body fat distribution in reproductive aged women. Eur J Clin Nutr. 2013 Mar;67(3):289-94. doi: 10.1038/ejcn.2013.4. Epub 2013 Feb 6.

Reference Type: RESULT

PMID: 23388669 (View on PubMed)

Abiemo EE, Alonso A, Nettleton JA, Steffen LM, Bertoni AG, Jain A, Lutsey PL. Relationships of the Mediterranean dietary pattern with insulin resistance and diabetes incidence in the Multi-Ethnic Study of Atherosclerosis (MESA). Br J Nutr. 2013 Apr 28;109(8):1490-7. doi: 10.1017/S0007114512003339. Epub 2012 Aug 30.

Reference Type: RESULT

PMID: 22932232 (View on PubMed)

Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.

Reference Type: DERIVED

PMID: 32476140 (View on PubMed)

Other Identifiers

DIEMED2

Identifier Type: -

Identifier Source: org_study_id