| CTRI Number |
CTRI/2024/02/062735 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Understanding How Different Foods Affect Blood Sugar Levels in Healthy People |
|
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 |
| AMW/ CTP/GYI/17-2023 Version1.1 Dated 16.11.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhu Sudan C |
| Designation |
Consultant Physician |
| Affiliation |
NRR Hospital |
| Address |
OPD consultation Room No 2,Ground floor NRR HospitalChikkabanavara HesaragattaMain Road, Bangalore-560090Karnataka, 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 |
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
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 |
1st floor, Unit no 101,102A,102B,103,104 and 105, Tower-A,SAS Tower , Medicity, Sector -38, Gurugram Haryana 122001 India |
| 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 Madhusudan C |
NRR Hospital |
OPD no -02, Dept of General Medicine
Ground floor
Hesaragatta main Road chikkabanavara Bangalore-560090
Bangalore
KARNATAKA |
9731518867
drmadhusudanmadhu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ashraya Medinova Pvt. Ltd |
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 once to the subjects with in 5 minutes |
| Intervention |
Product 1: DID- 31 |
The product with 25 g carbohydrate equivalent will be mixed with 626 ml of water will be given orally with in 5-10 min |
| Intervention |
Product 2: DRD- 32 |
The product equivalent to 25 g carbohydrate will be mixed with 694 ml±10 ml of water orally with in 5-10 min . |
| Intervention |
Product 3: KDC- 37 |
The product equivalent to 15.8 g of carbohydrate will be mixed with 200 ml skimmed milk contributing 9.2 g of carbohydrate totaling 25 g carbohydrate equivalent given orally with in 5-10 min. |
| Intervention |
Product 4: MRD-C-40 |
The product equivalent to 11.2 g of carbohydrate will be mixed with 300 ml skimmed milk contributing 13.8 g of carbohydrate totaling 25 g carbohydrate orally with in 5-10 min |
| Intervention |
Product 5: MMD-39 |
The product equivalent to 25 g of carbohydrate to be mixed with 330 ± 10 ml water orally with in 5-10 min |
| Intervention |
Product 6: ATS- 36 |
The product equivalent to 25 g of carbohydrate to be mixed with 66 ± 10 ml water orally with in 5-10 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adults in the age group of 18 and 45 years – male and female -1:1 ratio
Fasting blood glucose levels more than 100mg perdL.
BMI should be between 18.5 to 23 kg per 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 per m2 or more than 23 kg per 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)
urrent 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 (-5 15 30 45 60 90 and 120 min) in a day with respect to reference product |
-5 15 30 45 60 90 and 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)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2024 |
| Date of Study Completion (India) |
14/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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.
|