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

Clalit Health Services

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Other: high protein diet; Other: mediterranean diet restricted calorie

Study type: Interventional

Funder types: Other

Identifiers

NCT01615848

MMC12043-20kCTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

mediterranean diet restricted calorie

Experimental group

Description:

1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated \& polyunsaturated fat

Treatment:

Other: mediterranean diet restricted calorie

Other: mediterranean diet restricted calorie

high protein diet, restricted calorie

Experimental group

Description:

1500 k/calories 40 % carbohydrate 30% protein 30% fat

Treatment:

Other: high protein diet