High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)

Federal University of Rio Grande do Sul

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Dietary Supplement: High protein diet; Dietary Supplement: Normal protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01184963

04-364

Details and patient eligibility

About

The objective of this study is to assess the effects of a high protein (HP) and a normal protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index (BMI)-matched controls in a sample of southern Brazilian women.

Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.

The investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.

Enrollment: 40 patients

Sex: Female

Ages: 14 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women of reproductive age
• BMI ranging from 18.5 to 39.9 kg/m²

Exclusion criteria

• Use of any drugs known to interfere with hormone levels for at least 3 months before the study
• Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
• Other hyperandrogenic disorders than PCOS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Controls

Other group

Description:

Women in reproductive age regular ovulatory cycles

Treatment:

Dietary Supplement: High protein diet

Dietary Supplement: Normal protein diet

PCOS patients

Other group

Description:

Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance

Treatment:

Dietary Supplement: High protein diet

Dietary Supplement: Normal protein diet