| CTRI Number |
CTRI/2015/07/006013 [Registered on: 16/07/2015] Trial Registered Prospectively |
| Last Modified On: |
15/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on healthy people to see the effect on blood glucose levels after eating a high sugar food with fiber and to see the effect of fiber on hunger. |
|
Scientific Title of Study
|
A clinical study to determine the blood glucose response of a dietary fiber on high Glycemic index food and satiety response of a dietary fiber in healthy volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GRSR-DF-2015 Version 1.0 dated 28 Mar 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd. Jehangir Hospital Premises, 32 Sassoon Road, Pune- 411001.
Pune
MAHARASHTRA
411001
India |
| Phone |
9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd. Jehangir Hospital Premises, 32 Sassoon Road, Pune- 411001.
MAHARASHTRA
411001
India |
| Phone |
9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd. Jehangir Hospital Premises, 32 Sassoon Road, Pune- 411001.
MAHARASHTRA
411001
India |
| Phone |
9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Mr. Ajay Nilawar.
5-A,Anupam Society, S H Paralkar Road, Shivaji Park, Dadar, West Mumbai 400028. |
|
|
Primary Sponsor
|
| Name |
Mr Ajay Nilawar |
| Address |
5-A,Anupam Society, S H Paralkar Road, Shivaji Park, Dadar, West Mumbai 400028 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Almas Pathan |
Jehangir Clinical Development Centre |
Clinical Research Department, Jehangir Hospital Premises, 32 Sassoon Road, Pune.
Pune
MAHARASHTRA |
9763002830
almas.jikare@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary fiber |
It is a sachet of 5gms. It will be given to healthy volunteers only once on 2 days (Day 3 and Day 5). |
| Comparator Agent |
Glucose or White bread |
either 50 grams of glucose in a glass of water or 4 slices white bread will be given only once on 2 days (Day 1 and Day 3). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females in the age 18- 65 years (both inclusive).
2. Be of normal health as determined by the investigator from medical history, clinical and physical examination.
3. Random blood sugar level ≤ 200 mg/dl at screening.
4. BMI between 18.5 to 27 kg/m2 (both inclusive).
5. Must be willing to or likely to comply with all study requirements.
6. Must be able and willing to provide written informed consent.
7. Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
|
|
| ExclusionCriteria |
| Details |
1. Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.
2. Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction.
3. Current use of medication which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator.
4. Abuse of drugs or alcohol.
5. Known case of sensitivity to Gluten or Coeliac disease.
6. Pregnant or lactating women.
7. Currently participating or had participated in any other interventional study in last 1 month prior to screening.
8. Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Blood glucose response of the fiber
2. Change in satiety using visual analogue scale |
1. Blood glucose response of the fiber 180 min post administration of fiber.
2. Satiety response at 0 minutes, 15 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is being performed to asses the blood glucose response of the fiber on high glycemic index food and the satiety response of the fiber in healthy volunteers. It will have 4 visits. Once the volunteer will be screened and is eligible, the Day 1 and Day 3 visit will be performed to assess the blood glucose response and Day 5 visit will be performed to assess the satiety response of the fiber.
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