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CTRI Number  CTRI/2024/11/076906 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Dietary Consumption and Physical Activity in Women of Reproductive Age between 16 to 25 year age  
Scientific Title of Study   Dietary Consumption and Physical Activity in Women of Reproductive Age (16-25 years)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Monal Velangi 
Designation  Senior Dietician 
Affiliation   
Address  K.J.Somaiya Super Speciality Centre, Dietary department, Somaiya Ayurvihar, Eastern Express Highway, Sion east, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9136097274  
Fax    
Email  dr.monalvelangi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Monal Velangi 
Designation  Senior Dietician 
Affiliation  Dr BMN College 
Address  K.J.Somaiya Super Speciality Centre, Dietary department, Somaiya Ayurvihar, Eastern Express Highway, Sion east, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9136097274  
Fax    
Email  dr.monalvelangi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Monal Velangi 
Designation  Senior Dietician 
Affiliation  Dr BMN College 
Address  K.J.Somaiya Super Speciality Centre, Dietary department, Somaiya Ayurvihar, Eastern Express Highway, Sion east, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9136097274  
Fax    
Email  zainabbohra049@gmail.com  
 
Source of Monetary or Material Support  
Dr BMN College of Home Science, Matunga, Mumbai, 400019, India 
 
Primary Sponsor  
Name  Dr BMN College of Home Science 
Address  R.A kidwai Road Matunga, 400019, Mumbai, India 
Type of Sponsor  Other [Private college] 
 
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 
Rupali Sengupta  Dr BMN College  RA Kidwai road, Matunga, Mumbai
Mumbai
MAHARASHTRA 		 9892415789

rupali@bmncollege.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Diagnosed reproductive disorders other than PCOS. Pregnant or breastfeeding women.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Regular or irregular menstrual cycles.

No use of hormonal contraceptives or medications affecting the menstrual cycle.  
 
ExclusionCriteria 
Details  Men

Anyone under 16 years and above 25 years

Diagnosed reproductive disorders other than PCOS.

Pregnant or breastfeeding women.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Association between dietary patterns, physical activity, and menstrual health  1. Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Evidence to support dietary and lifestyle recommendations  baseline 
Insights into potential preventive measures for menstrual irregularities  Baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   26/11/2024 
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="0"
Months="5"
Days="5" 
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  

  1. The menstrual cycle is a complex process regulated by the endocrine system, which can be influenced by various factors including diet and lifestyle. Globally, millions of women suffer from menstrual irregularities and related symptoms. For instance, a study reported that approximately 75% of women experience some form of PMS, and 20-30% suffer from severe PMS that significantly impacts daily life [2]. Understanding how dietary patterns and lifestyle changes affect the menstrual cycle can provide valuable insights for improving women’s reproductive health. Recent studies suggest that diet and lifestyle significantly impact menstrual health. For instance, high-fat diets and sedentary lifestyles have been associated with irregular menstrual cycles and conditions such as polycystic ovary syndrome (PCOS). Conversely, diets rich in fruits, vegetables, and whole grains, combined with regular physical activity, appear to promote regular menstrual cycles [1].  

Given the widespread impact of dietary and lifestyle choices on reproductive health, there is a pressing need to conduct comprehensive studies that tell us the specific dietary patterns and physical activity levels that are most beneficial for women of reproductive age. Such research is essential for developing targeted interventions and public health strategies aimed at improving menstrual health and overall well-being. By concentrating on the relationship between food practices, physical activity, and reproductive health in women of reproductive age, my research aims to close this gap. To lessen the burden of reproductive health issues and encourage healthy lives, it is imperative to comprehend these interactions. 

 
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