| CTRI Number |
CTRI/2018/02/012035 [Registered on: 21/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Functional Food] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of a functional food product in Regulating Blood Glucose in Pre-diabetic Subjects |
|
Scientific Title of Study
|
A Randomized, double-blind, parallel, placebo-controlled, interventional Study to Evaluate the Effect of Test/placebo biscuits in Regulating Blood Glucose and Safety in Pre-diabetic Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS-PH-041605 Version 00 dated 06 Jul 16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Doshi |
| Designation |
Principal Investigator |
| Affiliation |
Karmic Lifesciences LLP |
| Address |
Karmic Lifesciences LLP
7 and 8, Garden View,
Opposite Bodakdev Auda Garden,
Near Allen Institute, Off Sindhu Bhavan Road,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
07966219521 |
| Fax |
07966219549 |
| Email |
vipul.doshi@karmiclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maheshvari Tamboli |
| Designation |
Head Operation- PHC |
| Affiliation |
Karmic Lifesciences LLP |
| Address |
Karmic Lifesciences LLP
Unit No.2, Ground Floor, Reliable Plaza,
Plot No. K10, Thane Belapur Road,
Airoli, Navi Mumbai
Mumbai
MAHARASHTRA
400708
India |
| Phone |
02261438603 |
| Fax |
02261438603 |
| Email |
maheshvari.tamboli@karmiclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Patel |
| Designation |
Project Coordinator |
| Affiliation |
Karmic Lifesciences LLP |
| Address |
Karmic Lifesciences LLP
7 and 8, Garden View,
Opposite Bodakdev Auda Garden,
Near Allen Institute, Off Sindhu Bhavan Road,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
07966219521 |
| Fax |
07966219549 |
| Email |
nikhil.patel@karmiclifesciences.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Center, ITC Ltd
Peenya Industrial Area, 1st Phase,
Bangalore - 560 058 |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Center |
| Address |
#3, 1st Main, Peenya Industrial Area,
1st Phase, Bangalore
|
| Type of Sponsor |
Other [FMCG] |
|
|
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 Vipul Doshi |
Karmic Lifesciences LLP |
7 & 8, Garden View,
Ground floor
PHC department
Opposite Bodakdev Auda Garden,
Near Allen Institute, Off Sindhu Bhavan Road,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT |
07966219521
07966219529
vipul.doshi@karmiclifesciences.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pre-diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Placebo |
3 Biscuits Twice daily
Route of administration: oral
Duration: 84 days |
| Comparator Agent |
Test Biscuit 1 |
3 Biscuits Twice daily
Route of administration: oral
Duration:84 days
|
| Intervention |
Test Biscuit 2 |
3 Biscuits Twice daily
Route of administration: oral
Duration: 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females greater than or equal to 18 and less than or equal to 65 years of age
2. Body mass index of greater than or equal to 18.5 and less than or equal to 30 kg per m2
3. Pre-diabetic subjects with fasting blood glucose between 100 and 125 mg/dL (called impaired
fasting glucose or IFG), IGT (greater than or equal to 140 and less than 200), and HbA1c levels greater than or equal to 5.7% and less than or equal to 6.4%
4. Subjects willing to comply with diet control
5. Subjects with history of stable weight, defined as no significant weight change (less than ±5%)
within three months prior to enrollment
6. If on anti-hypertensive therapy, the dosage must be constant for at least 2 months prior to the
screening visit, based on medical history.
7. Females of child-bearing potential and males should be willing to use adequate methods of
contraception.
8. Must be willing to give written informed consent and comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Type 1 or type 2 diabetes mellitus
2. Subject with lipid abnormalities or thyroid disorders
3. Pregnant or lactating women
4. Subjects requiring a fibre free diet
5. Subject requiring enteral tube feed or parenteral nutrition
6. Diagnosed with an eating disorder such as bulimia or binge eating
7. Any acute gastrointestinal disease within 2 weeks prior to study entry
8. History of Cancer
9. Clinically significant cardiac disease or endocrine abnormalities
10. Suspicion of drug abuse, abuse of/addiction to alcohol
11. Untreated major psychiatric disorder
12. History of bariatric surgery
13. Known HIV positive
14. Serum creatinine of greater than or equal to 1.5 mg per dL
15. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values greater than or equal to 2.5 X Upper Limit of Normal (ULN)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effects assessed in terms of maintenance and/or mean change in blood glucose (FBG, PPBG) from baseline to end of treatment i.e. 12 weeks, between the two test biscuit groups and compare to placebo group |
At week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maintenance and /or mean change in
HbA1c, QUICKI, body weight, waist circumference, BMI, lipid parameters (HDL, LDL, VLDL and TG),
BP,fructosamine levels, adiponectin, PAI-1, IL-6, CRP and safety of biscuits |
at week 12 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2016 |
| Date of Study Completion (India) |
05/09/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was a randomized, double blind, parallel group trial for evaluating the safety and efficacy of test/placebo biscuits in pre-diabetic subjects. Total 150 subjects were enrolled from single center (India) to get at least 129 evaluable subjects. To access outcome maintenance and /or mean change in fasting blood glucose from baseline to end of treatment i.e week 12 and safety of biscuits in pre-diabetic subjects maintenance and /or mean change in parameters like HbA1c, HDL, VLDL, TG, BP, Fructosamine level. |