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Carbohydrate Reduction and Exercise in women with Polycystic Ovary Syndrome

Low-carbohydrate Diet and Endurance Exercise for women with Polycystic Ovarian Syndrome: a Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4wjqxcv
Enrollment
Unknown
Registered
2023-05-11
Start date
2022-08-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

polycystic ovary syndrome

Interventions

This is a double-blind randomized clinical trial that will follow 48 women with polycystic ovary syndrome. Participants will be randomized into two groups through number generation software. Participa
G07.203.650.240
G11.427.410.698.277

Sponsors

Fundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina (Fapesc)
Lead Sponsor
Universidade do Extremo Sul Catarinense
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Women between 18 and 50 years old diagnosed with polycystic ovary syndrome

Exclusion criteria

Exclusion criteria: Pregnant; lactating; climacteric women

Design outcomes

Primary

MeasureTime frame
Evaluate the change in body composition of women who underwent a low-carbohydrate diet and exercise compared to the control group through bioimpedance ;To verify possible changes in the serum parameters (SDHEA, total and free testosterone, lipid profile and fasting glycemia, insulin and HOMA-IR) of women who performed diet and exercise compared to the control group;Compare whether there were changes in the respiratory function of women who underwent a diet with reduced carbohydrates and exercise compared to the control group by means of spirometer analysis

Secondary

MeasureTime frame
To analyze whether there was an improvement in the quality of sleep of women who underwent a low-carbohydrate diet and eexercise compared to the control group by the Epworth Sleepiness Scale and the Pittsburgh Sleep Quality Index;To analyze the serum values of Interleukin-6 and TNF-alpha in women who underwent a diet with reduced carbohydrates and exercise compared to the control group;To verify improvement in the quality of life in women who underwent a diet with reduced carbohydrates and exercise compared to the control group by whoqol-bref scale;To compare the presence of anxiety and depression symptoms in women who underwent a diet with reduced carbohydrates and exercise and in the control group through the DASS-21 questionnaire (Depression, Anxiety and Stress Scale)

Countries

Brazil

Contacts

Public ContactTamy Colonetti

Universidade do Extremo Sul Catarinense

tamycolonetti@unesc.net+55(48) 34312748

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 6, 2026