| CTRI Number |
CTRI/2021/02/030921 [Registered on: 02/02/2021] Trial Registered Prospectively |
| Last Modified On: |
29/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical saftey and efficacy trial of Sugarlite a marketeted product on Healthy lifestyle modification |
|
Scientific Title of Study
|
“An Open label , two arms active controlled and randomized , Clinical Study to Evaluate the Efficacy and Safety of Sugarlite, A Unique Sugar Blended Formulation in Normal to Mild overweight subjects.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Kumar Prabhu |
| Designation |
Ohysician and clinical coordinator |
| Affiliation |
Sarani Biointgra private limited |
| Address |
Tirumala Healthcare NO 809 Ring Road BSK 3rd stage Hosakerahalli Bangalore
A 406 Gopalan jewels Doddakaalasandra Kanakapura Main road Bangalore
Bangalore
KARNATAKA
560085
India |
| Phone |
9945825226 |
| Fax |
|
| Email |
sunilpr13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar Prabhu |
| Designation |
Ohysician and clinical coordinator |
| Affiliation |
Sarani Biointgra private limited |
| Address |
Tirumala Healthcare NO 809 Ring Road BSK 3rd stage Hosakerahalli Bangalore
A 406 Gopalan jewels Doddakaalasandra Kanakapura Main road Bangalore
Bangalore
KARNATAKA
560085
India |
| Phone |
9945825226 |
| Fax |
|
| Email |
sunilpr13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar Prabhu |
| Designation |
Ohysician and clinical coordinator |
| Affiliation |
Sarani Biointgra private limited |
| Address |
Tirumala Healthcare NO 809 Ring Road BSK 3rd stage Hosakerahalli Bangalore
A 406 Gopalan jewels Doddakaalasandra Kanakapura Main road Bangalore
Bangalore
KARNATAKA
560085
India |
| Phone |
9945825226 |
| Fax |
|
| Email |
sunilpr13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zydus Wellness |
| Address |
Zydus Corporate ParK Scheme no 63, Survey no 536, Khoraj Gandhinagar, Nr Vaishnodevi Circle Ahmedabad 382481 |
| 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 |
| Mr Ramanna |
Tirumala Healthcare Limited |
No 809 Ring Road BSK 3rd Stage Hosakerahalli Bangalore
Bangalore
KARNATAKA |
9945825226
ramanna.l@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifeline ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mildl obese or healh males and females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sugar in its normal form |
A normal amount of sugar 4 to 5 tsp should be used for this trial and then compared with the intervention product a sugar substitute |
| Intervention |
Sugar substitute |
this is a study where an sugar substitute is compared with normal sugar in a comaprative study on body weight , waist and hip circumference and metabolic parameters like RBS and HbA 1 C. About 2 to 3 tsp of sugar substitute is used in the entire trial per day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects of both sexes in the age group of 18 - 45 years
•Normal to Pre obese subjects (BMI – 23.00kg/M2 to 26 kg/M2)
•Subjects willing to give written informed consent.
•Those who agree to follow the general guidelines on diet, sugar intake and exercise.
•Subjects who have not participated in similar kind of study in last 4 weeks.
|
|
| ExclusionCriteria |
| Details |
• Subjects with established hypertension, renal, hepatic or cardiac failure
• Endocrine disorders like Hypothyroid ( if already on treatment)
• Subjects with Dyslipidemia or Inborn errors of Fat metabolism.
• Subjects with Postprandial sugars above 150 mg /dl in two tests so can be labelled
Early Diabetic
• History of drug hyper sensitivity or allergic condition that might interfere with the study
• Use of drugs or dietary supplements that might influence body weight, body fat, or serum lipid levels like Anti diabetic drugs like Metformin and Statins.
• Pregnant & lactating women.
• Not willing to sign informed consent form.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight , BMI , Blood glucose and Lipid Parameters |
Baseline , 30 days , 60 days and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood cholesterol , Trigycerides, random bllod sugar and Hba1 C values |
Once every month for 3 months after baseline values |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/02/2021 |
| Date of Study Completion (India) |
01/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a non DCGI appoved trial for sugar substitute already marketed in India under food guidlelines and to know whetrher this is better than sugar in certain parameters. The Primary goals are to see body weight, Hip girth, waist girth , Hip to Waist ratio , RBS and HBA 1c values while Lipid profile and Liver function tests and blood parameters are for secondary endpoints and safety analysis of this sugar substitute |