| CTRI Number |
CTRI/2023/08/056568 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| 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 |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 |
| Phone |
7022247227 |
| Fax |
|
| Email |
Palaniyamma.Durairaj@Amway.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 |
| Phone |
7022247227 |
| Fax |
|
| Email |
Palaniyamma.Durairaj@Amway.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudha 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
560091
India |
| Phone |
9481574797 |
| Fax |
|
| Email |
sudharaj@clinisydresearch.com |
|
|
Source of Monetary or Material Support
|
| Amway Global Services India Pvt Ltd 1st floor, Unit no 101,102A,102B,103,104 and 105,
Tower-A, SAS Tower , Medicity, Sector -38, Gurugram Haryana 122001 India |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhu Sudan C |
NRR Hospital |
OPD consultation Room No 2, Ground floor NRR Hospital
Chikkabanavara Hesaragatta Main Road, Bangalore-560090
Karnataka, India
Bangalore
Bangalore
KARNATAKA |
9886627611
drmadhusudanmadhu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Ashraya Medinova Private limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glucose |
25 g of Glucose in 200 ml water
will be given orally to the
subjects twice in the Study |
| Intervention |
Product 1: MRD – M-24 |
MRD – M - 24– 25 g carbohydrate equivalent of the product will be mixed with 250 ml of water. Will be given.
orally to the subjects once during the Study |
| Intervention |
Product 2: MRD –T-25 |
MRD – T: 24– 25 g carbohydrate equivalent of the product will be mixed with 250 ml of water. Will be given.
orally to the subjects once during the Study |
| Intervention |
Product 3: MDJ-26 |
MDJ - 26 – 25 g of carbohydrate equivalent of the product will be mixed with 200ml of skimmed milk Will be given. orally to the subjects once during the Study |
| Intervention |
Product 4: KDJ-27 |
KDJ-27-25 g of carbohydrate equivalent of the product will be mixed with 200ml of Skimmed milk. Will be given. orally to the subjects once during the Study |
| Intervention |
Product 5: CLG-28 |
CLG-28 - 25 g carbohydrate equivalent of the product will be mixed with 250 ml of water. Will be given. orally to the subjects once during the Study |
| Intervention |
Product 6: MGA-29 |
MGA-29 - 25 g Carbohydrate equivalent of the product will be mixed with 250 ml of water. Will be given. orally to the subjects once during the Study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
-Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years – male and female (1:1 ratio)
-Fasting blood glucose levels less than 100mg/dL.
-BMI should be between 18.5 to 23 kg/m2
-Lipid profile (Total cholesterol) within normal range as applicable
-Agree to participate in the study
-Able and willing to follow all study related instructions.
-Must be willing to give written informed consent and comply with the study procedures.
-Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
|
|
| ExclusionCriteria |
| Details |
-Subjects with BMI less than 18.5kg/m2 or more than 23 kg/m2 will be excluded from the study.
-Total cholesterol higher than normal range.
-Subjects particularly on any special diet
-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)
-current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders
-Pregnant or lactating women
-Patient having participated in any other clinical trial within one month prior to screening
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
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 |
The Glycaemic Index of the test products on Day-4 Day-7 Day-10 Day-16 Day-19 & Day-22 will be compared with reference product on Day-1 & Day-13 at
Fixed intervals of -5 15 30 45 60 90 & 120
min |
|
|
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)= "13"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/08/2023 |
| Date of Study Completion (India) |
12/09/2023 |
| 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)
Modification(s)
|
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
|