| CTRI Number |
CTRI/2021/04/032809 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Low calorie sweetener sucralose] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of replacing sugars with sweetener sucralose for 24 weeks on body weight, glycemic and lipid parameters among Overweight Asian Indian adults
|
|
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 |
Zydus Wellness Ltd |
| Address |
4th Cross, Talacauvery Layout, Jakkuru Layout, Jakkuru, Bengaluru, Karnataka 560092 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Participants in control group will be advised to follow routine diet and physical activity. |
| Intervention |
Low calorie sweetener-Sucralose (in either pellet or powder or liquid form) |
LCS-Sucralose (in either pellet or powder or liquid form) will be given to study
participants to be used in place of sugars in tea/coffee/ beverages daily for a period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
.Overweight/ obese participants (Asian Indian specific cut off)
.Willing to follow study protocol
.Willing to give informed consent
.Willing to use LCS-sucralose for 12 weeks
.Participants with features of metabolic syndrome, pre- diabetes.
|
|
| ExclusionCriteria |
| Details |
.Participants with known history or newly diagnosed diabetes
.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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the change in body weight by replacing sugar (20-30g/day) with LCS-sucralose (pellet/powder/liquid form) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessing the effect of replacing sugars with low-calorie sweetener sucralose among over weight and obese adults on
Glycemic parameters-Fasting glucose, glycated haemoglobin (HbA1c), fasting insulin and HOMA IR
Lipid profile-serum triglyceride, HDL, LDL and VLDL cholesterol
Inflammatory markers- TNF alpha and hs-CRP
Advanced glycation end products (in a subsample of 50 participants)
Gut microbiome (in a subsample of 50 participants) |
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
|
The study findings could further provide clear public health message on the use of LCS -Sucralose. 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 overweight adults. |