polycystic ovary syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Intervention group: The spirulina supplementation, with a dose of 500 mg, will be taken three times daily with meals for better absorption over a period of 12 weeks, provided by (Golds
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women diagnosed with polycystic ovary syndrome (PCOS) based on physician assessment and the Rotterdam criteria Age between 20 and 45 years Body mass index (BMI) ranging from 25 to 35 kg/m² Willingness to participate in the study
Exclusion criteria
Exclusion criteria: Presence of hepatic, renal, cardiovascular diseases, diabetes mellitus, Cushing's syndrome, or hyperprolactinemia History of allergy to algae or seafood products Use of weight loss medications Use of oral contraceptive pills (OCPs) for birth control Pregnancy or lactation Engagement in a regular exercise program Adherence to a specific diet within the past three months Use of any type of supplement (including nutritional or herbal) within the past three months History of severe allergic reaction to a supplement or placebo Use of tobacco, alcohol, or hookah
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Testosterone hormone. Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Blood samples for testosterone measurement will be collected after a 10 to 12-hour overnight fast. Following collection, the blood samples will be kept at room temperature for 30 minutes to allow clot formation. The samples will then be centrifuged at 3,000 rpm for 10 minutes. The separated serum will be aliquoted into specific microtubes and stored at –80°C until analysis. Serum hormone concentrations will be measured using high-sensitivity ELISA kits, and all samples will be analyzed in a single batch.;Dehydroepiandrosterone sulfate hormone. Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Blood samples for Dehydroepiandrosterone sulfate measurement will be collected after a 10 to 12-hour overnight fast. Following collection, the blood samples will be kept at room temperature for 30 minutes to allow clot formation. The samples will then be centrifuged at 3,000 rpm for 10 minutes. The separated serum will be aliquoted into specific microtubes and stored at –80°C until analysis. Serum hormone concentrations will be measured using high-sensitivity ELISA kits, and all samples will be analyzed in a single batch.;Estradiol (E2) hormone. Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Blood samples for estradiol measurement will be collected after a 10 to 12-hour overnight fast. Following collection, the blood samples will be kept at room temperature for 30 minutes to allow clot formation. The samples will then be centrifuged at 3,000 rpm for 10 minutes. The separated serum will be aliquoted into specific microtubes and stored at –80°C until analysis. Serum hormone concentrations will be measured using high-sensitivity ELISA kits, and all samples will be analyzed in a single batch.;Progesterone hormone. Timepoint: At baseline and after 12 weeks of Spirulina supplem | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Patients’ body weight will be measured using a Seca scale with an accuracy of 0.5 kg, while they are barefoot and wearing minimal clothing.;Body mass index(BMI). Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Body mass index (BMI) will be calculated using the formula weight (kg) divided by the square of height (m), i.e., weight (kg)/height (m)².;Low-Density Lipoprotein Cholesterol (LDL-C). Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: At the beginning and end of the study, after selecting eligible participants and grouping them, blood samples for measuring Low-Density Lipoprotein Cholesterol will be collected after a 10 to 12-hour overnight fast. After collection, the blood samples will be kept at room temperature for 30 minutes to allow clot formation, followed by centrifugation at 3,000 rpm for 10 minutes. The serum will be separated and aliquoted into specific microtubes and stored at –80°C until analysis and all samples will be analyzed in a single batch.;Waist circumference. Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Waist circumference of the participants will be measured using a flexible measuring tape at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, following a normal expiration.;Hip circumference (HC). Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Hip circumference will be measured using a flexible measuring tape at the point of the greatest protrusion of the buttocks.;Body composition. Timepoint: At baseline and after 12 weeks of Spirulina supplementation. Method of measurement: Body composition will be assessed using a Tanita body analyzer.;Appetite. Timepoint: At baseline and after 12 weeks of Spirulina supplem | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNiloofar Barani
Tabriz University of Medical Sciences
Outcome results
None listed