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CTRI Number  CTRI/2024/08/072006 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of protein supplement on post meal blood sugar levels in people with diabetes. 
Scientific Title of Study   Effect of Diabetes Specific Protein Supplement (DSPS) on post prandial glycemic responses in individuals with type 2 diabetes: A randomized single center crossover study. 
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 Shobha A Udipi 
Designation  Research Director and Head, Hon Director-Integrative Nutrition and Ayurceuticals 
Affiliation  Kasturba Health Society Medical Research Center 
Address  Kasturba Health Society Medical Research Center, Integrative Nutrition and Ayuceuticals Division, 6th Floor, 17, Khandubhai Desai Road, Near Rasraj Hotel, Vile Parle (west). Near ACME Ghar, Mumbai

Mumbai
MAHARASHTRA
400056
India 
Phone  9819324083  
Fax    
Email  drshobhaudipi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Sheryl S Salis 
Designation  Registered Dietitian, Founder-Nurture Health Solutions 
Affiliation  Nurture Health Solutions 
Address  Nurture Health Solutions, Nutrition Research Division, Room 101, Ganesh Krupa, opposite prabodhankar thackeray Krida Sankul, Shahaji Raje Marg, Vile Parle East.

Mumbai
MAHARASHTRA
400057
India 
Phone  9820242478  
Fax    
Email  sheryl@nurturehealthsolutions.com  
 
Details of Contact Person
Public Query
 
Name  Ms Sheryl S Salis 
Designation  Registered Dietitian, Founder-Nurture Health Solutions 
Affiliation  Nurture Health Solutions 
Address  Nurture Health Solutions, Nutrition Research Division, Room 101, Ganesh Krupa, opposite prabodhankar thackeray Krida Sankul, Shahaji Raje Marg, Vile Parle East.


MAHARASHTRA
400057
India 
Phone  9820242478  
Fax    
Email  sheryl@nurturehealthsolutions.com  
 
Source of Monetary or Material Support  
Nutricia International Private Limited 
 
Primary Sponsor  
Name  Nutricia International Private Limited 
Address  Kamani Junction, Agastya Corporate Park, Building Amiti, D Wing, Unit No. 304, 3rd Floor, Lal Bahadur Shastri Marg, opp. Fire Brigade, Kurla West, Mumbai, Maharashtra 400070 
Type of Sponsor  Other [Private Limited Company] 
 
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 Ami Sanghvi  Sanghvi Eye and Diabetes Care Centre  7, Northern heights, building no 1,first floor, bharucha road extension, near sammelan hotal, Dahisar East, Mumbai, Maharashtra 400068.
Mumbai
MAHARASHTRA 
9820287276

dramisanghvi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Inter System Biomedica Ethics 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  Diabetes Specific Protein Supplement (DSPS)  25g of Diabetes specific protein supplement (DSPS) with 200 ml milk with reduced quantity (30g) of dehydrated upma or poha. 
Comparator Agent  Isocaloric breakfast  Isocaloric control breakfast (pre packaged 80g dehydrated upma and poha) 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  People with T2D (with duration of diabetes morethan 6 months) and treated with oral antidiabetic drugs stable for at least 2 months or controlled with diet alone. HbA1c 7-9% (7 & 9% included)
In case of People with T2D with hypertension, it needs to be treated and well controlled.
In case of People with T2D with dyslipidemia, it needs to be treated and well controlled.
BMI between 18.5-29.9 (18.5 & 29.9 included)
People on home remedies or taking diabetes specific nutrition formula would be asked to practice abstinence from these foods/formulations at least for a week before study and during the study.
Willing to comply with the study protocol
Written informed consent
 
 
ExclusionCriteria 
Details  People with Type 1 DM
People with Type 2 DM on insulin or acarbose or short acting sulfonylurea (e.g.meglitinide) medication or GLP 1 analogues
Pregnant women
Lactating mothers
People with uncontrolled diabetes, HbA1c more than 9.0.%
People with significant heart disease (uncontrolled dyslipidemia - fasting S. cholesterol more than 260mg /dL and S. triglycerides more than 300mg/dL) on screening visit
People with presence of any severe diabetic complication and/or major systemic disease.
People with renal disease, S. Creatinine more than 1.5mg/dL, requiring dialysis
People with liver disease, AST and ALT more than 2.5times the upper normal limits
People with recent history of stroke or unstable angina or coronary artery diseases in the last six months before inclusion.
Presence of ketone bodies in urine analysis.
People with IBS, IBD, chronic acidity, and bloating
Hemoglobin level below 10 gm%.
History of substance abuse or alcoholism in the past one year.
People who have been infected with HIV/Hepatitis B or Hepatitis C or COVID in the last 3 months as per information given by people.
People who had a major infection in the past 3 weeks and have been treated with antibiotics.
People who are on corticosteroids or oral contraceptives.
People in any clinical trials within 30 days of admission to the study.
Known allergies or intolerance to milk, soy, lactose or any component of the test product
People following veganism.
People with IBS, IBD, chronic acidity, and bloating. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Post prandial glucose response (iAUC)  at baseline 0 min and post-meal at 30, 60, 90, 120,150 and 180 min 
 
Secondary Outcome  
Outcome  TimePoints 
Post prandial insulin area under the curve, Postprandial peak glucose (mg/dl), Postprandial peak insulin (µU/mL), Maximum postprandial glucose increase from baseline (delta peak), Maximum postprandial insulin increase from baseline (delta peak)  at baseline 0 min and post-meal at 30, 60, 90, 120,150 and 180 min 
 
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   Phase 2 
Date of First Enrollment (India)   14/08/2024 
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="8"
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  

Prevalence of type 2 diabetes mellitus has been increasing at an alarming level with nearly 101 million Indians living with diabetes in India as per latest ICMR-INDIAB report. With such a high incidence, only 7.7% of individuals with diabetes are found to achieve all three ABC target (HbA1c, blood pressure and LDL- cholesterol levels). This indicates that achievement of targets and adoption of healthy behaviors remains sub-optimal in India. 

In people with T2DM, blood glucose levels are usually higher in the morning than at other times of the day. Additionally, commonly consumed breakfast items in India like upma and poha are rich in simple carbohydrates and lack protein and fiber.

In a high carbohydrate consuming nation like India, meeting dietary protein requirements can be a challenge especially for vegetarians.

Increasing intake of dals/pulses in a vegetarian diet may not be an effective solution as a lot of people experience bloating and gas. Dairy products are also advised to be consumed in moderation since they are rich in calories and saturated fat. Even non-vegetarians struggle to meet their requirement as the consumption is strongly influenced by religion and cultural practices and so the frequency of consumption may not be sufficient enough to meet the daily protein requirements. To bridge this gap between the intake and requirement, Diabetes Specific Protein Supplement (DSPS) can be useful if dietary sources are not sufficient.

This study therefore aims to assess whether the post meal glycemic response with partial meal replacement using DSPS at breakfast is lower compared to an isocaloric control breakfast in individuals with type 2 diabetes mellitus.


 

 
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