| CTRI Number |
CTRI/2021/04/032686 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Low calorie sweetener sucralose] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of using sweetener sucralose for 12 weeks on body weight, glycemic and lipid parameters among adults with diabetes in India
|
|
Scientific Title of Study
|
Effect of low- calorie sweetener - Sucralose (Sugar Free Natura) on cardio metabolic risk factors and Gut Microbiome among obese and adults with diabetes in India- A randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
President and Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research Madras
Diabetes Research Foundation No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India
Chennai
TAMIL NADU
600086
India |
| Phone |
914439988816 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods, Nutrition & Dietetics Research, Madras
Diabetes Research Foundation, No 4, Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
India
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods, Nutrition & Dietetics Research, Madras
Diabetes Research Foundation, No 4, Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
India
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
Source of Monetary or Material Support
Modification(s)
|
|
ZYDUS WELLNESS PRODUCTS LIMITED
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej – Gandhinagar Highway, Ahmedabad – 382481, Gujarat |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition & Dietetics Research No 4, Conran
Smith Road Gopalapuram Chennai |
| Type of Sponsor |
Other [Non Government Research Organisation] |
|
|
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 V Mohan |
Madras Diabetes Research Foundation |
Department of Foods
Nutrition & Dietetics
Research No 4 Conran
Smith Road
Gopalapuram Chennai
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
914439988816
drmohans@diabetes.ind.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female with type 2 diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Routine diet and and physical activity with no major lifestyle modification for 12 weeks |
| Intervention |
LCS- sucralose (pellet/powder/liquid form) |
Participants will be advised to use LCS-Sucralose (in either pellet or powder or liquid form) in place of sugars in tea/coffee/ beverages for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
.Adults with type 2 diabetes and BMI greater than 18.5
.Hba1c 8-12%
.Individuals on stable OHA/insulin dose
.Willing to follow study protocol
.Willing to give informed consent
.Willing to use LCS-sucralose for 12 weeks
|
|
| ExclusionCriteria |
| Details |
.Any acute infections like viral fever, typhoid, cold, diarrhea, constipation last 1 month
.Individuals with any disorders of liver, kidney, thyroid, or other endocrine diseases or other complications such as respiratory disorders, diabetes, cancer or heart attack and stroke that hinders the intervention
.Individuals with any eating disorder
.Participants undergoing any treatment or medications including antibiotics
.Pregnant and lactating Women
.Plans to relocate in the next 3 years.
.Planning longer duration of travel out of town
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the change in HbA1c with LCS- sucralose (pellet/powder/liquid form) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessing the effect of LCS-sucralose on body weight
Glycemic parameters ,Lipid profile,Inflammatory markers, Advanced glycation end products and
Gut microbiome
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
15/04/2021 |
| 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="3"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To our knowledge this study will be the first of its kind in India that will bring out evidence on the effect of low-calorie sweetener sucralose on body weight, waist circumference, fasting blood glucose, HbA1c, insulin resistance, lipid profile, inflammatory markers and gut microbiome both among adults with type 2 diabetes. The study findings could further provide clear public health message on the use of LCS -Sucralose. |