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CTRI Number  CTRI/2019/12/022470 [Registered on: 20/12/2019] Trial Registered Prospectively
Last Modified On: 16/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [safety and efficacy Study]  
Study Design  Other 
Public Title of Study   Safety and efficacy study of Sugar Free Green in Healthy Normal Overweight and Prediabetic Overweight Patients in Controlled Activity Regimen 
Scientific Title of Study   An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Sugar Free Green in Healthy Normal Sugar Level Overweight and Pre-diabetic Overweight Adult Human Subjects in Controlled Physical Activity Regimen 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KLS19-ZYW-226 Version: 00, Dated 29 Nov 19  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp. Auda Garden, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  917966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp. Auda Garden, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  917966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Patel 
Designation  Associate Director-Consumer Research  
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp. Auda Garden, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  917966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Zydus Wellness Limited 
Address  House No. 6 &7, Sigma Commerce Zone, Near Iskcon Temple, Sarkhej - Gandhinagar Highway, Ahmedabad 380015, Gujarat 
Type of Sponsor  Other [FMCG Nutraceutical Industries] 
 
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 Nayan Patel  Cliantha Research  Consumer Research Department, Garden View Corporate House No. 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT 		 9909013286
917966219549
nkpatel@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E663||Overweight,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Sugar Free Green  Subject will be instructed to use the test product instead of their routine sugar. The test product is equivalent to one teaspoon of sugar in sweetness. One pellet of Sugar free Green (100 mg) is equivalent to one teaspoon of sugar (5 g) in sweetness. 1.0g of measured spoon of Sugar free Green powder Conc. is equivalent to one teaspoon of sugar (5g) in sweetness. To be used by subject for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Age: 18 to 55 yrs
2) Sex: Male and/or non-pregnant/ non-lactating females
3) Body Mass Index (BMI) of ≥25 to ≤ 30.0 kg/m2
4) For Pre-diabetics subjects: Fasting Blood Glucose level from 100-125 mg/dL (called impaired fasting glucose or IFG) and HbA1c levels ≥5.7% to ≤6.4%
5) Subjects willing to follow diet plan
6) Subjects willing to reduce their weight and waist circumference
7) Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within 03 months prior to enrollment and the physical activity level lesser than 2.0
8) Normal renal and liver tests
9) Subject must be willing to abstain to eat any other sugar containing products, any other form of sugar usage for the duration of the study 
 
ExclusionCriteria 
Details  1) Pregnant female subjects or females planning to get pregnant during study duration
2) Subjects having Type 1/ Type 2 Diabetes Mellitus
3) Subjects having Insulin Resistance
4) Subjects having Lipid Abnormalities
5) Subject diagnosed with eating disorders such as bulimia or binge eating
6) History of Positive HIV test
7) History of Hepatitis B Virus
8) Subject with any history of drug and alcohol abuse
9) History of Cancer
10) History of clinically significant cardiac disease or endocrine abnormalities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Effect of test product will be measured in terms of change in body weight from baseline
2. Effect of test product will be measured in terms of change in waist circumference from baseline 		 On Day 30, Day 60 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the test product in terms of adverse events reported by subjects or assessed by Investigator during study.  On Day 30, Day 60 and Day 90 
Effect of test product will be assessed in terms of reduction in lipid profile along with lipoprotein levels from baseline  On Day 30, Day 60 and Day 90 
Effect of test product will be assessed in terms of reduction in HbA1c from baseline  On Day 30, Day 60 and Day 90. 
To assess the amount of sugar consumption of subjects based on subjective evaluation on baseline  On Day 30, Day 60 and Day 90 
Effect of test product will be assessed in terms of Satiety level of the subjects based on subjects’ feedback from Baseline  On Day 30, Day 60 and Day 90 
Safety of the test product will be assessed in terms of adverse events reported by subjects or assessed by Investigator.  On Day 30, Day 60 and Day 90. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2019 
Date of Study Completion (India) 30/12/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study would involve consumption of Sugar Free Green, by Normal Healthy Overweight subjects and Pre-Diabetic Overweight patients, to evaluate the mean change in the body weight and waist circumference by blood sample collection and subjective perception before and after test product consumption. Safety of the test products will be assessed throughout the study duration in terms of adverse events reported by subject or assessed by Investigator during study. 
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