Low-Carb Versus Mediterranean Diet in PCOS

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Status: Not yet enrolling

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Other: Mediterranean diet; Other: low-carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05272657

Pcos2typesofDiet

Details and patient eligibility

About

This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.

Full description

The study aims to clarify the impact of nutritional recommendations for women with polycystic ovary syndrome on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . Women with PCOS are randomized into 2 treatment groups: one group on a low-carbohydrate diet and the other on a Mediterranean diet. The adhearance to a prescribed diet will be controlled through food intake diaries using a mobile application with electronic reporting forms.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45.

• Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group):

  • signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone)
  • signs of chronic anovulation
  • ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche.

Exclusion criteria

• The presence of hyperprolactinemia
• Cushing's syndrome
• Ongenital hyperplasia of the adrenal cortex
• Hypothyroidism
• Androgen-producing tumors
• Regular use of drugs and dietary supplements that affect the function of the ovaries
• Adrenal glands
• Metabolism of carbohydrates
• Lipids
• Microbiota composition during the 2 months preceding the study
• Pregnancy
• Lactation
• Significant comorbidities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

low-carbohydrate diet

Experimental group

Description:

subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.

Treatment:

Other: low-carbohydrate diet

Mediterranean diet

Experimental group

Description:

subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.

Treatment:

Other: Mediterranean diet