FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062534 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutrition Intervention]  
Study Design  Single Arm Study 
Public Title of Study   Effect of dietary management on women with polycystic ovary syndrome (PCOS) 
Scientific Title of Study   Impact of Nutrition Intervention on Clinical and Metabolic Outcomes in Women with Polycystic Ovary Syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shraddha S 
Designation  UGC-Senior Research Fellow 
Affiliation  Department of Studies in Food Science and Nutrition, University of Mysore 
Address  Department of Studies in Food Science and Nutrition, University of Mysore, Manasagangotri campus, Mysuru

Mysore
KARNATAKA
570006
India 
Phone  9739067049  
Fax    
Email  shraddha.shivakumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Asna Urooj 
Designation  Professor 
Affiliation  Department of Studies in Food Science and Nutrition, University of Mysore 
Address  Department of Studies in Food Science and Nutrition, University of Mysore, Manasagangotri campus, Mysuru

Mysore
KARNATAKA
570006
India 
Phone  9448489334  
Fax    
Email  asnaurooj@foodsci.uni-mysore.ac.in  
 
Details of Contact Person
Public Query  
Name  Shraddha S 
Designation  UGC-Senior Research Fellow 
Affiliation  Department of Studies in Food Science and Nutrition, University of Mysore 
Address  Department of Studies in Food Science and Nutrition, University of Mysore, Manasagangotri, Mysuru

Mysore
KARNATAKA
570006
India 
Phone  9739067049  
Fax    
Email  shraddha.shivakumar@gmail.com  
 
Source of Monetary or Material Support  
Financial support received from University Grants Commission, New Delhi, India, in the form of Junior Research Fellowship. UGC-Ref. No. 1594/(NET-DEC 2018) 
Infrastructural support for the trial extended by University of Mysore  
 
Primary Sponsor  
Name  Shraddha S 
Address  UGC-Senior Research Fellow, Department of Studies in Food Science and Nutrition, University of Mysore, Manasagangotri, Mysuru, Karnataka-570006 
Type of Sponsor  Other [Academic Institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asna Urooj  Department of Studies in Food Science and Nutrition  Nutrition Counselling Room, ground floor, University of Mysore, Manasagangotri Campus, Mysuru-570006
Mysore
KARNATAKA 		 9448489334

asnaurooj@foodsci.uni-mysore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee, University of Mysore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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). Mode of administration: Oral. Ingredients: All the ingredients will be procured from local markets which are generally recognized as safe (GRAS) and follows good manufacturing practices (GMP). Duration: minimum 6 weeks. The prepared formulation (microbially safe) will be provided to the study participants as a snack bar (50 g/day). Additionally, participants will be provided a diet chart that adheres to the three main meal pattern, including the supplied snack bar, and meets the ICMR-recommended age- and gender-specific nutrient requirements. Follow-up: 0th week, 3rd week and 6th week.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HOMA-IR  At baseline and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
HOMA-IR by equation.
Fasting insulin by ELISA.
Fasting sugar by glucometer. 		 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.  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. 		 At baseline and 6th week 
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 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  		 N/A 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
Close