| CTRI Number |
CTRI/2024/05/066846 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of GLUBLOC on Blood gulcose and insulin levels in patients with diabetes |
|
Scientific Title of Study
|
Impact of GLUBLOC On postprandial blood gulcose
and insulin levels in patients with diabetes and healthy
individuals post high carb meal intake |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balamurugan Ramadass |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 147, Center for Excellence of Clinical Microbiome Research, AIIMS-BBSR
Khordha
ORISSA
751019
India |
| Phone |
09677048798 |
| Fax |
|
| Email |
balaramadass1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan Ramadass |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 147, Center for Excellence of Clinical Microbiome Research, AIIMS-BBSR
ORISSA
751019
India |
| Phone |
09677048798 |
| Fax |
|
| Email |
balaramadass1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan Ramadass |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 147, Center for Excellence of Clinical Microbiome Research, AIIMS-BBSR
ORISSA
751019
India |
| Phone |
09677048798 |
| Fax |
|
| Email |
balaramadass1@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
My Pura Vida Wellness Private Limited (Puravida) |
| Address |
5th Floor, Salarpuria Sattva, Knowledge City, Hitech City, Madhapur, Inorbit Mall Rd, Hyderabad, Telangana 500081 |
| Type of Sponsor |
Other [online health and wellness 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 |
| Dr Balamurugan Ramadass |
AIIMS Bhubaneswar |
Room No 147 Department of Biochemistry 1st Floor Academic Building AIIMS-BBSR
Khordha
ORISSA |
8547805341
balaramadass1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhuabneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Glucose Level and Normal BMI |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
GLUBLOC Sachet |
1 gram powder sachet with GLUBLOCâ„¢ 350mg (a proprietary blend of Morus alba L and Malus domestica peel extracts) with Microcrystalline cellulose and Dibasic calcium phosphate. Taken twice a day with two major meals. |
| Comparator Agent |
Placebo Sachet |
1 gram powder sachet with (Placebo) a Composition of Microcrystalline cellulose and Dibasic calcium phosphate. Taken twice a day with two major meals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy subjects:
1.Aged between 18–60 years,
2.BMI between 18.5 and 22.9 kg/m2
3.Fasting blood glucose range between 3.9 and 5.5 mmol/L.
Diabetes Patients
1.Aged between 18–60 years,
2.BMI between 18.5 and 29.9 kg/m2
3.Fasting blood glucose ≥ 7.2 mmol/L (or) ≥ 126 mg/dl or HbA1C ≥ 6.5%
|
|
| ExclusionCriteria |
| Details |
Healthy subjects:
1.Women who were pregnant or lactating
2.Any known food allergies
3.Subjects with a bleeding disorder
4.Pre-existing medical condition or taking medication known to affect glucose regulation and/or influence digestion and absorption of nutrients
5.History of diabetes mellitus (type I/II) or they used antihyperglycaemic drugs or insulin to treat diabetes or related conditions
6.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
Diabetes Patients:
1.food allergies.
2.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.
3.Subjects with the history of uncontrolled hypertension and/or hyperthyroidism.
4.History of alcoholism
5.Subjects with psychiatric or neurological disability or mental health disorder
6.Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
7.Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding.
8.Subjects who refuse to sign informed consent.
9.According to the investigator’s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To document the impact of
GLUBLOC supplementation in patients with diabetes and healthy
individuals |
Baseline samples before intervention, end of the 3rd Month and end of the six month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To document adverse effect if any on study product |
Baseline samples before intervention, end of the 3rd Month and end of the six month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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)
|
In the current study we aimed at understanding
the anti-diabetic activity of the nutraceutical powder containing glublocâ„¢ (a
proprietary blend of Morus alba L and Malus domestica peel extract) in
improving the HbA1C, glucose and inulin levels in
diabetic individuals. This will be added as a nutraceutical/ dieraty
supplement to their current medication and evaluate the improvements in HbA1C,
glucose and inulin levels at the end of 3rd month and 6th
month of intervention and the assessments were compared to placebo intake |