| 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
|
|
|
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
|
|
|
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. |