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Evaluating the effect of consumption of synbiotic pomegranate juice in women with poly cystic ovarian syndrome

Evaluating the effect of consumption of synbiotic pomegranate juice on glycemic markers, oxidative stress, inflammation and androgen profile of women with poly cystic ovarian syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017020732439N1
Enrollment
92
Registered
2017-10-17
Start date
2017-01-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

poly cystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: 1. Patients who receive 2 liters of pomegranate juice each week, which consists of pomegranate juice, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 we
Treatment - Other
Placebo
1. Patients who receive 2 liters of pomegranate juice each week, which consists of pomegranate juice, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks.
2. Patients who receive 2 liters of pomegranate juice each week, in the form of disposable bottles for 8 weeks.
3. Patients who receive 2 liters of synbiotic juice each week, which consists of inulin, lactobacillus and pomegranate flavor, in the form of disposable bottles for 8 weeks.
4. Patients who receive 2 liters of placebo juice each week, which consists of pomegranate flavore, in the form of disposable bottles for 8 weeks.

Sponsors

Research Associate, Faculty of Nutrition and Food Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 48 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria PCOS could be diagnosed, according to the ROTTERDAM criteria, by two of the following three features: 1) Oligomenorrhea (Less Than 6-9 Menses per Year) or amenoria (Non-vaginal bleeding for at least 6 months) 2) Clinical Hyperandrogenism (Hirsutism score higher than 8 or obviose acne) or increase blood testosterone levels (Testosterone levels above2 nmo/l) 3) Polycystic Ovaries on Ultrasound (The presence of 12 or more cysts with a diameter of 9.2 mm in one or both ovaries or the size of the ovary 10 cm3 or more) BMI>18 Having permission the doctor and informed consent to participate in the study Not Inclusion criteria: Other medical conditions related to excess androgens such as increased blood prolactin, nonclassical congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumors and acromegaly wemon with severe diseases of the stomach, intestines, heart, kidney, liver, lung, chronic, autoimmune, inflammatory and AIDS Patients undergoing chemotherapy smokers Lactating women Patients treated with corticosteroids and antibiotics The use of supplements of vitamins, minerals and antioxidants Those taking hormone pills or supplements Patients using insulin to treat diabetes Patients with a special diet Patients with specific exercise program Exclusion citeria: Lack of any of the compounds at a rate of more than 4 days a week The loss of any of the inclusion criteria

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric method.;Fasting plasma insulin. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).;Insulin resistante. Timepoint: before and 2 month after intervention. Method of measurement: HOMA-IR.;Insulin sensivity. Timepoint: before and 2 month after intervention. Method of measurement: QUICKI.;Hs-CRP. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).;MDA. Timepoint: before and 2 month after intervention. Method of measurement: biochemichal method.;TAC. Timepoint: before and 2 month after intervention. Method of measurement: calorimetric.;DHEAS. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).;Testosterone. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).

Secondary

MeasureTime frame
Mensturation cycle. Timepoint: before and 2 month after intervention. Method of measurement: questionare.;Hirsutism. Timepoint: before and 2 month after intervention. Method of measurement: questionare.;Alopecia. Timepoint: before and 2 month after intervention. Method of measurement: questionare.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Esmaeilinezhad

Food and nutrion science university

sahar.esnj8@gmail.com+98 71 3225 6271

Outcome results

None listed

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