| CTRI Number |
CTRI/2024/01/061799 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
To assess the positive Impact of a nutraceutical (GLUBLOCâ„¢ granules) on postprandial blood glucose levels when taken along with the carbohydrate rich meal |
Scientific Title of Study
Modification(s)
|
A Prospective, Randomised, Placebo Controlled Study to Evaluate the Impact of GLUBLOCâ„¢ on postprandial blood glucose levels in healthy individuals post carbohydrate rich meal intake. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| GLUBLOC 2023, 16-12-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR K SOMNATH GUPTA |
| Designation |
Sr. Consultant Physician and Diabetology MBBS, DNB, MHSC Diabetology |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 135, OP 4 reception, Department of Internal Medicine, 1st Floor, Yashoda Hospitals, Hitech city, Cyber towers to JNTU road, Hyderabad, Telangana
Hyderabad
TELANGANA
500084
India |
| Phone |
996911130 |
| Fax |
|
| Email |
somnath.gupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Chaitanya Gali |
| Designation |
Head of R and D |
| Affiliation |
My PuraVida Wellness Pvt Ltd |
| Address |
My PuraVida Wellness Pvt Ltd, 5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana
Hyderabad
TELANGANA
500081
India |
| Phone |
9391752535 |
| Fax |
|
| Email |
chaitanya@formen.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Chaitanya Gali |
| Designation |
Head of R and D |
| Affiliation |
My PuraVida Wellness Pvt Ltd |
| Address |
My PuraVida Wellness Pvt Ltd, 5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana
Hyderabad
TELANGANA
500081
India |
| Phone |
9391752535 |
| Fax |
|
| Email |
chaitanya@formen.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| My Pura Vida Wellness Pvt Ltd, 5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana 500081 |
|
Primary Sponsor
Modification(s)
|
| Name |
My Pura Vida Wellness Pvt Ltd |
| Address |
5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana 500081 |
| Type of Sponsor |
Other [For Profit company] |
|
|
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 |
| K Somnath Gupta |
Yashoda Hopsital |
Room No 135, OP 4 reception, Department of Internal Medicine, 1st Floor, Yashoda Hospitals, Hitech city, Cyber towers to JNTU road, Hyderabad, Telangana
Hyderabad
TELANGANA |
996911130
somnath.gupta@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE OFYASHODA ACADEMY OF MEDICAL EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lifestyle management using a plant based supplement to moderate the postprandial blood sugar spike. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
GLUBLOCâ„¢ Granules (STUDY 1) |
A proprietary blend of Morus alba L and Malus domestica peel extracts - 350 mg, proprietary blend of Morus alba L extract and Malus domestica peel extract (350 mg) along with the excipients microcrystalline cellulose (MCC) and di calcium phosphate (DCP).
The subjects will receive intervention only once during the entire duration of the study, either on day 1 or day 5 based on the computer generated randomisation. |
| Comparator Agent |
PLACEBO Granules (STUDY 1) |
Refined rice Starch 350 mg, proprietary blend of Morus alba L extract and Malus domestica peel extract (350 mg) along with the excipients microcrystalline cellulose (MCC) and di calcium phosphate (DCP).
The subjects will receive Comparator agent/placebo only once during the entire duration of the study, either on day 1 or day 5 based on the computer generated randomisation. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 to 60 years
BMI between 18.5 and 29.9 kg per m2
Fasting blood glucose greater than 70 mg per dl and less than or equal to 99 mg per dl
|
|
| ExclusionCriteria |
| Details |
History of hypersensitivity to any of the investigational product, excipients, or Any known food allergies.
Pre-existing medical condition or taking medication known to affect glucose regulation or influence digestion and absorption of nutrients
History of diabetes mellitus (type I or II) or they used antihyperglycemic drugs or insulin to treat diabetes or related conditions
Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
Subjects with the history of uncontrolled hypertension or hyperthyroidism.
History of alcoholism
Subjects with psychiatric or neurological disability or mental health disorder
Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
Subjects who donot have basic understanding of English language, which include speaking or writing in English.
Female subjects who are pregnant or had planned for pregnancy in the following months or were breast feeding.
Subjects who refuse to sign informed consent.
According to the investigators opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the impact of Glublocâ„¢ granules on postprandial changes in blood glucose levels post carbohydrate rich meal intake. |
Time points: t0 (fasting), t30, t60, t90 and t120 minutes on Day 1 & Day 5. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Observation of Adverse events during the study period |
Day 1 & Day 5 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
10/02/2024 |
| Date of Study Completion (India) |
21/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
Modification(s)
|
Study 1: Design Overview Day 1: Following an overnight fast of at least 10 hours, subjects will be randomized to placebo and treatment arms (50 subjects per each arm). Vital signs, height and weight parameters will be collected. Baseline (0 min) reading of blood glucose levels will be recorded using Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG), they will be randomly allocating placebo or treatment. Before taking the meal, one sachet of GLUBLOC™ granules will be sprinkled all over the food and mixed gently with a spoon. Subjects should eat the meal with in 15 minutes or less; however, post-study, there is no diet restriction for the rest of the day. 3 day washout and crossover of subjects (ie., placebo subjects will receive GLUBLOC™ and vice versa) Day 5: Same procedure as day 1. Sample collection: Blood glucose levels will be measured at t30, t60, t90 & t120 minutes through a finger prick assessment with Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). Questions related to gastrointestinal discomfort will be asked, such as, nausea, abdominal cramp, distension and flatulence at the end of the study on day 1 and day 5.
|