Effect of diet therapy in treatment of patients with polycystic ovary syndrome

Clinical trial of the effect of soy intake compared with the control diet on metabolic profiles in patients with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701295623N104

Enrollment

Registered

2017-02-01

Start date

2017-01-17

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Soy-protein diet, 0.8 g/kg protein (35% animal protein, 35% soy protein, and 30% other vegetable proteins), daily for 8 weeks. Intervention 2: Control group: Standa

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Aged18–40 years old Patients with PCOS according to Rotterdam criteria

Exclusion criteria

Exclusion criteria: Pregnant women Hyperprolactinaemia Thyroid dysfunction Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Using HOMA formula.;Insulin sensitivity. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Using QUICKI formula.	—

Secondary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026