Impact of Nutrition Intervention on Clinical and Metabolic Outcomes in Women with Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- HOMA-IR
研究概览
简要总结
This single-arm clinical trial investigates the impact of an omega-3-rich, low-glycemic index, functional food-based snack bar on the metabolic and clinical profiles of women diagnosed with polycystic ovary syndrome, based on the Rotterdam criteria. Individuals located in Mysuru city, Karnataka, meeting the inclusion and exclusion criteria will be recruited. The formulated product (microbially safe) will be provided to the study participants as a snack bar weighing 50g per day for a minimum period of 6 weeks. Furthermore, participants will be provided with an isocaloric diet plan that meets their specific nutritional needs based on age and gender, as recommended by the ICMR. The diet chart will incorporate the provided snack, which can be consumed either as a mid-morning or evening snack. The primary outcome variable is HOMA-IR, which will be measured at the beginning and end of the intervention period. Follow-up appointments are scheduled at the baseline, 3rd, and 6th weeks of the intervention to assess the primary and secondary outcome variables and to ensure compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
HOMA-IR
时间窗: At baseline and 6th week
次要结局
- HOMA-IR by equation.(Fasting insulin by ELISA.)
- Oxidative stress markers: malondialdehyde by TBARS assay, total antioxidant capacity by FRAP assay, serum uric acid by enzymatic kit method.(At baseline, 3rd week and 6th week)
- Inflammatory marker- CRP by immunoturbidimetry.(At baseline, 3rd week and 6th week)
- Lipid profile- total cholesterol, HDL-C, triglycerides by enzymatic kit method; LDL-C- Martin-Hopkins equation.(At baseline, 3rd week and 6th week)
- Body composition by InBody 770 multifrequency bioelectrical impedance method.(At baseline, 3rd week and 6th week)
- Quality of life by health related PCOSQ scale (L. Cronin et al) licensed by McMaster University(At baseline and 6th week)
- Depression by PHQ9.(Anxiety by GAD7.)
- Dietary data assessed using 3-days 24Hr recall and food frequency questionnaire(At baseline, 3rd week and 6th week)
- Hirsutism assessed by modified-Ferriman-Gallwey score as perceived by the subjects(At baseline and 6th week)
研究者
Shraddha S
Department of Studies in Food Science and Nutrition, University of Mysore