Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Efficacy of functional food-based formulation (snack bar) in women with polycystic ovary syndrome: Type of Intervention: Omega-3 rich, functional food-based formulation (snack bar).
Mo
Sponsors
Shraddha S
Eligibility
Inclusion criteria
Inclusion criteria: Women diagnosed with polycystic ovary syndrome as per Rotterdam criteria 2003 with the presence of at least two of the following findings: hyperandrogenism, ovulatory dysfunction, and polycystic ovaries. Willingness to participate, and residents of Mysuru. Women who did not consume omega-3 or any other nutraceutical supplements in the last 3 months or followed a special diet and did not use tobacco.
Exclusion criteria
Exclusion criteria: Subjects with hyper-prolactinemia, congenital adrenal hyperplasia, androgen-secreting neoplasm, Cushing’s syndrome, attenuated 21-hydroxylase deficiency (as per Rotterdam criteria), as well as a history of diabetes or any other chronic disorders in the last 6 months, thyroid dysfunction, a history of at least 2 weeks of infection, trauma or surgery, or significant stress such as bereavement, psychiatric comorbidity, etc., will be excluded. Pregnancy and lactation. Women on contraceptive pills. History of allergy to nuts, flaxseeds or sesame seeds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IRTimepoint: At baseline and 6th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition by InBody 770 multifrequency bioelectrical impedance method.Timepoint: At baseline, 3rd week and 6th week;Depression by PHQ9. Anxiety by GAD7.Timepoint: At baseline and 6th week;Dietary data assessed using 3-days 24Hr recall and food frequency questionnaireTimepoint: At baseline, 3rd week and 6th week;Hirsutism assessed by modified-Ferriman-Gallwey score as perceived by the subjectsTimepoint: At baseline and 6th week;HOMA-IR by equation. Fasting insulin by ELISA. Fasting sugar by glucometer.Timepoint: At baseline, 3rd week and 6th week;Inflammatory marker- CRP by immunoturbidimetry.Timepoint: At baseline, 3rd week and 6th week;Lipid profile- total cholesterol, HDL-C, triglycerides by enzymatic kit method; LDL-C- Martin-Hopkins equation.Timepoint: At baseline, 3rd week and 6th week;Oxidative stress markers: malondialdehyde by TBARS assay, total antioxidant capacity by FRAP assay, serum uric acid by enzymatic kit method.Timepoint: At baseline, 3rd week and 6th week;Quality of life by health related PCOSQ scale (L. Cronin et al) licensed by McMaster UniversityTimepoint: At baseline and 6th week | — |
Countries
India
Contacts
Public ContactShraddha S
Department of Studies in Food Science and Nutrition, University of Mysore
Outcome results
None listed