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CTRI Number  CTRI/2025/01/079766 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Raw Jackfruit Flour]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Impact of raw jackfruit flour on satiety and blood glucose levels 
Scientific Title of Study   Impact of raw jackfruit flour incorporated recipes on satiety and blood glucose levels 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preethi Rahul 
Designation  PhD Student 
Affiliation  SNDT Womens University Juhu Mumbai 
Address  SNDT Womens University Department of Food Science & Nutrition Juhu Tara Rd Daulat Nagar Santacruz West Mumbai Maharashtra 400049

Mumbai
MAHARASHTRA
400049
India 
Phone  9920450836  
Fax    
Email  preethi199@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Leena Raje 
Designation  PhD Guide 
Affiliation  SNDT Womens University Juhu Mumbai 
Address  SNDT Womens University Department of Food Science & Nutrition Juhu Tara Rd Daulat Nagar Santacruz West Mumbai Maharashtra 400049

Mumbai
MAHARASHTRA
400049
India 
Phone  9920385557  
Fax    
Email  rajeleena@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Leena Raje 
Designation  PhD Guide 
Affiliation  SNDT Womens University Juhu Mumbai 
Address  SNDT Womens University Department of Food Science & Nutrition Juhu Tara Rd Daulat Nagar Santacruz West Mumbai Maharashtra 400049

Mumbai
MAHARASHTRA
400049
India 
Phone  9920385557  
Fax    
Email  rajeleena@gmail.com  
 
Source of Monetary or Material Support  
Aditya Care Clinic Mulund East 
 
Primary Sponsor  
Name  SNDT Womens University Juhu Mumbai 
Address  SNDT Womens University Department of Food Science & Nutrition Juhu Tara Rd Daulat Nagar Santacruz West Mumbai Maharashtra 400049 
Type of Sponsor  Research institution 
 
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 Abhijit A Jadhav  Aadityacare Clinic  Purnima Darshan first floor 90 ft road Mulund East
Mumbai
MAHARASHTRA 
9224299990

abjdoc2001@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Aditya Care clinic  No Objection Certificate 
Seva Mandal Education Societys Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Raw Jackfruit Flour  Raw Jackfruit flour is prepared from dehydrated, mature, unripe jackfruits using the bulb, seed and strands Jackfruit 365 
Comparator Agent  Wheat flour  Commercially available wheat flour ( Aashirvad) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diabetes clinics with dietitians in Mumbai
Diagnosed as T2DM for more than 1 year on oral antihyperglycemic agents only
Currently on 14 day CGMS device 
 
ExclusionCriteria 
Details  Patients with renal and hepatic comorbidities
Pregnant women and children 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Lower blood glucose and higher satiety levels.
 
14 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Lower GI with raw Jackfruit Flour
Product acceptability will be good at 30%
 
GI in 3 days
Product acceptability on 2 different days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

India is currently grappling with a significant rise in lifestyle-related health issues, primarily attributed to a shift towards sedentary lifestyles and the consumption of processed foods high in sugar, salt, and fat. This transition has been fueled by various factors including the prevalence of nuclear families, global influences, powerful social media, and the ready availability of convenience foods. As a consequence, India has become a hotspot for non-communicable diseases (NCDs), notably diabetes and obesity. Recent statistics reveal alarming figures, with a weighted prevalence of 11.4% for diabetes, 28.6% for generalized obesity, and 39.5% for abdominal obesity, among others. (Anjana et al, 2023).

The dietary landscape in India paints a concerning picture, with the consumption of fiber-deficient ultra-processed foods such as chips, biscuits, and sweets on the rise, contributing significantly to daily energy intake. Conversely, the intake of fruits and vegetables remains strikingly low, further exacerbating the nutritional imbalance. Such dietary patterns have grave implications, as evidenced by the surge in metabolic NCDs across urban and rural areas. (What India Eats, ICMR 2020).

Recognizing the pivotal role of dietary fiber in managing NCDs, emerging research underscores its significance in mitigating conditions such as Type 2 Diabetes, obesity, hypertension, and cardiovascular disorders. Studies have demonstrated that high fiber intake correlates with reduced risk factors and improved health outcomes, making it a cornerstone of preventive healthcare strategies. Notably, interventions promoting fiber-rich diets have shown promising results in controlling blood glucose levels, reducing body weight, and improving cardiovascular health. (IDA fiber position paper 2018, Barber et al 2020).

However, despite its proven benefits, the actual fiber intake among the Indian population falls short of recommended guidelines, particularly among low-income groups and women. This deficiency is further compounded by the lack of fiber-rich options in traditional Indian diets, necessitating a concerted effort to raise awareness and promote dietary diversification. (Krishnaswamy et al, 2011)

In this context, the potential of jackfruit emerges as a promising solution. Recognized for its rich fiber content and diverse medicinal properties, jackfruit presents a unique opportunity to address the nutritional inadequacies prevalent in Indian diets. Notably, raw jackfruit flour has garnered attention for its therapeutic qualities, including its efficacy in managing Type 2 Diabetes, lowering blood pressure, and enhancing gut health. Moreover, its prebiotic activity and antioxidant properties offer additional health benefits, positioning it as a valuable functional food. (Swami et al, 2018).

Despite its immense potential, awareness surrounding raw jackfruit flour remains limited, particularly outside of South India where most manufacturers are based. Consequently, there is a pressing need to expand research efforts and promote the widespread adoption of this novel functional food. Such initiatives hold not only individual health benefits but also significant social implications, including support for jackfruit farmers and the reduction of food wastage, thereby contributing to broader sustainable development goals.

In light of these considerations, this study aims to explore the health benefits of raw jackfruit flour and its potential as a dietary intervention for combating NCDs, particularly Type 2 Diabetes. By elucidating its nutritional composition, therapeutic properties, and culinary applications, this research endeavors to bridge the gap between traditional wisdom and modern dietary needs, ultimately fostering healthier lifestyles and resilient communities.

 
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