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Comparison Between Mediterranean Diet and High Protein Diet in Women With Polycystic Ovary Syndrome (PCOS)

Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01615848
Enrollment
100
Registered
2012-06-11
Start date
2013-04-30
Completion date
2013-11-30
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic Ovary syndrome (PCOS), diet, mediterranean diet, high protein diet

Brief summary

Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.

Detailed description

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance. Low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown. In this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.

Interventions

OTHERmediterranean diet restricted calorie

1500 k/cal 30% fat

OTHERhigh protein diet

50 pcos diagnosed women will be assigned to high protein diet for 18 month

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Polycystic ovary syndrome

Exclusion criteria

* Pregnancy * Lactation 6 month prior to study * Known hyperandrogenism * More then 5 kg weight loss 6 month prior to study * Imbalance pituitary hormones * Alcohol or drug abuse * Chronic disease - kidney/heart/diabetes/lung * Psychiatric disease * Drug use accept contraceptive pills

Design outcomes

Primary

MeasureTime frame
improvement in metabolic outcomes of women with pcos18 months

Secondary

MeasureTime frame
improvement in clinical symptoms: acne, hirsutism and menstrual regularity18 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026