Mediterranean Diet Versus Hypocaloric Diet in PCOS

NCT02397174 | Unknown

• 1 other identifier: DIEMED1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary syndrome; hypocaloric diet; Ovarian Cysts; Ovarian Diseases; Obesity; Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• improvement in insulin resistance measured by HOMA index

  6 months

Secondary Outcomes (3)

• 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

• composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)

  6 months

Study Arms (2)

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.

Other: mediterranean diet, restricted calorie

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.

Other: hypocaloric diet, restricted calorie

Interventions

mediterranean diet, restricted calorie OTHER

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

Mediterranean Diet

hypocaloric diet, restricted calorie OTHER

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

hypocaloric diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria)
• BMI \> 25

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona: lead
• Federico II University: collaborator
• University of Modena and Reggio Emilia: collaborator

Study Sites (1)

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

Salerno, Salerno, 84131, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 18158291 RESULT

• 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.

  PMID: 20858697 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Ovarian Cysts; Ovarian Diseases; Obesity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Francesco Orio, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Orio, MD

CONTACT

+39 338 6759977; francescoorio@virgilio.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 24, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

IT (1)