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CTRI Number  CTRI/2024/11/077021 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 16/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to evaluate effect of consumption of food products on Blood Sugar in healthy human volunteers. 
Scientific Title of Study   A study to evaluate effect of consumption of food products on Glycemic index in healthy human volunteers 
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 Madhusudan C 
Designation  General Physician  
Affiliation  NRR Hospital 
Address  OPD consultation Room No 2, Ground floor NRR Hospital Chikkabanavara Hesaragatta Main Road, Bangalore-560090 Karnataka, India Bangalore Bangalore KARNATAKA

Bangalore
KARNATAKA
560090
India 
Phone  9886627611  
Fax    
Email  drmadhusudanmadhu123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D Palaniyamma 
Designation  Senior Manager-Clinical Affairs and Nutrition, Innovation and Science-AGSI 
Affiliation  Amway Global Services India Pvt Ltd 
Address  Unit no 101,102A,102B,103,104 and 105, Tower-A, SAS Tower, Medicity, Sector -38, Gurugram Haryana Gurgaon HARYANA 122001 India

Gurgaon
HARYANA
122001
India 
Phone  7022247227  
Fax    
Email  Palaniyamma.Durairaj@Amway.com  
 
Details of Contact Person
Public Query  
Name  DrSudha Raj 
Designation  Director 
Affiliation  CLINISYD Research Global Solutions Pvt Ltd 
Address  CLINISYD Research Global Solutions Pvt Ltd #1/1, 14th Cross, Malagala Main Rd, Malagala, Krishnananda Nagar, Naagarabhaavi, Bengaluru Bangalore KARNATAKA

Bangalore
KARNATAKA
560091
India 
Phone  9481574797  
Fax    
Email  sudharaj@clinisydresearch.com  
 
Source of Monetary or Material Support  
Amway Global Services India Pvt Ltd 
 
Primary Sponsor  
Name  Amway Global Services India Pvt Ltd 
Address  Unit No. 101-105, Tower A, SAS Tower Medicity, Sector 38, Gurgaon, Haryana 122001 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 MadhuSudan C  NRR Hospital  OPD consultation Room No 2, Ground floor NRR Hospital Chikkabanavara Hesaragatta Main Road, Bangalore-560090 Karnataka, India Bangalore Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9886627611

drmadhusudanmadhu123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CLINISYD Research Global Solutions Pvt. Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male and Female 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glucose 25 g  25 g of Glucose in 200 ml water will be given orally to the subjects twice in the Study 
Intervention  KBC- 50– 66.30 g   KBC- 50– 66.30 g of the product with 25 g carbohydrate equivalent once in the study  
Intervention  MA- 53- 45.12 g   product to be mixed with 113 ± 10 ml water to make batter. Upon preparation, 115 ± 2-gram dosa equivalent to 25 gram carbohydrate to be given once in the study  
Intervention  MAC- 54- 56.8 g   product to be mixed with 142 ± 10 ml water to make batter. Upon preparation, 118 ± 2-gram dosa equivalent to 25 gram carbohydrate to be given once in the study. 
Intervention  RA-51- 48.08 g   product to be mixed with 120 ± 10 ml water to make batter. Upon preparation, 112 ± 2-gram dosa equivalent to 25 gram carbohydrate to be given once in the study. 
Intervention  RAC- 52- 49.35 g   product to be mixed with 123 ± 10 ml water to make batter. Upon preparation, 110 ± 2-gram dosa equivalent to 25 gram carbohydrate to be given once in the study. 
Intervention  WMC-48-40.74 g   The Product will be mixed with 300 ml skimmed milk contributing 13.8 g of carbohydrate totaling 25 g carbohydrate equivalent once in the study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years – male and female (1:1 ratio)
2.Fasting blood glucose levels more than 100mg/dL.
3.BMI should be between 18.5 to 23 kg/m2
4.Lipid profile (Total cholesterol) within normal range as applicable
5.Agree to participate in the study
6.Able and willing to follow all study related instructions.
7.Must be willing to give written informed consent and comply with the study procedures.
8.Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
 
 
ExclusionCriteria 
Details  1.Subjects with BMI less than 18.5kg/m2 or more than 23 kg/m2 will be excluded from the study.
2.Total cholesterol higher than normal range.
3.Subjects particularly on any special diet
4.Subjects suffering from any systemic disorders (diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV)
5. current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders
6.Pregnant or lactating women
7.Patient having participated in any other clinical trial within one month prior to screening
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess glycemic index using blood sugar
levels measured at fixed intervals 		 Assessment of blood glucose levels at -5, 15, 30, 45, 60 90 and 120 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To assess change in hematological and
biochemical parameters from baseline to end of
the study.
- Assessment adverse events during the study
period 		 At baseline & end of the Study 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/11/2024 
Date of Study Completion (India) 25/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  
The glycemic index (GI) is a measure of the blood glucose-raising potential
of the Carbohydrate content of a food compared to a reference food
(generally pure glucose) (https://lpi.oregonstate.edu/mic/food-beverages/gl
ycemic-index-glycemic-load). It is measured in a scale of 0-100 where
below 55 is considered as low glycemic index, 56- 69 as medium glycemic
index and 70 and above as high glycemic index. Foods that have refined
sugar contents have generally more glycemic index and might affect the
blood sugar levels whereas foods with typically less sugar and more fibre
have less glycemic index.
Subjects who fulfil the eligibility criteria will be enrolled in the study after
signing the informed consent form.
Present study is aimed to evaluate the glycemic index of Six food
products by Amway. This will be a single blind, repeated, cross over study
in 14 subjects
 
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