| CTRI Number |
CTRI/2023/01/048985 [Registered on: 13/01/2023] 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 |
GI -Glycemic Index |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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 Hospital
Chikkabanavara
Hesaragatta Main Road,
Bangalore-560090
Karnataka, India
Bangalore
KARNATAKA
560090
India |
| Phone |
9886627611 |
| Fax |
|
| Email |
nrrhospital.research@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 101-105
Tower A
SAS Tower Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
7022247227 |
| Fax |
|
| Email |
Palaniyamma.Durairaj@Amway.com |
|
Details of Contact Person
Public Query
|
| Name |
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, Karnataka 560091
#1/1, 14th Cross,
Malagala Main Rd, Malagala, Krishnananda Nagar, Naagarabhaavi, Bengaluru, Karnataka 560091
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-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 |
| Dr Sujith |
NRR Hospital |
NRR Hospital
4th floor, Clinical research Room No 1
Chikkabanavara,
Hesaragatta Main Road
Bangalore-560090
Bangalore
KARNATAKA |
7022247227
sujithjnrr08@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 |
Age: 18 to 45 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glucose |
25 g of Glucose in 200 ml water will be given orally to the subjects on Day 1/Visit-2 and Day 10/Visit 5 |
| Intervention |
Product 1 – BDK-01 |
BDK-01 - 46.875 g in 200 ml water will be given orally to the subjects on Day 4/Visit-3,once during the Study |
| Intervention |
Product 2 - BDK-01 |
BDK-01 - 21 g + 300 ml of skimmed milk (13.8 g of carbohydrate) will be given orally to the subjects on Day 7/Visit-4,once during the Study |
| Intervention |
Product 3 - BKB -13 |
BKB -13 - 43.55 g of bar will be given orally along with 200ml water to the subjects on Day 13/Visit-6,once during the Study |
| Intervention |
Product 4 - XWB -14 |
XWB -14 - 45.76 g of bar in 200 ml water will be given orally to the subjects on Day 16/Visit-7, once during 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 < 100mg/dL.
3.BMI should be between 18.5 to 25 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 25kg/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
|
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 13 and Day 16 will be compared with reference product on day 1 and day 10 at Fixed intervals of -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 and 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)
|
18/01/2023 |
| Date of Study Completion (India) |
18/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/02/2023 |
|
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
|
|
|
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/glycemic-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 four food products by Amway.
This will be a single blind, repeated, cross over study in 14 subjects
|