| CTRI Number |
CTRI/2025/08/093675 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Metaberine® on Postprandial Blood Glucose in Prediabetic Individuals |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Trial to Assess the Effect of Metaberine® on Postprandial Blood Glucose in Prediabetic Individuals |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-ZH-169, Version 1.0 dated 09 June 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devendra Naik N |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD No.03, Ground Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drdevendranaik.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ZeusHygia LifeSciences Private Ltd, First Floor, Plot No.47, Raviraja Industries, Technocrats
Industrial Estate, Balanagar, Hyderabad, Telangana-500037 India |
|
|
Primary Sponsor
|
| Name |
ZeusHygia LifeSciences Private Ltd |
| Address |
irst Floor, Plot No.47, Raviraja Industries, Technocrats Industrial Estate, Balanagar, Hyderabad, Telangana-500037 India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Devendra Naik N |
BGS Global Institute of Medical Sciences |
Room No. 32, OPD No.3,
Ground Floor, No.67, BGS
Health and Education City,
Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8792516793
drdevendranaik.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Instiitute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R73||Elevated blood glucose level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metaberine |
Oral administration of single dose of Metaberine once a day for 14 days |
| Comparator Agent |
Placebo |
Oral administration of single dose of Placebo once a day for 14 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with fasting blood glucose levels between 100 mg per dL and 125 mg per dL 2.Subjects with post-prandial blood glucose level of 140 to 199 mg per dL 3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subject willing and able to give informed consent and comply with the study procedures 5.Subjects who agrees to participate in this human application test and signs a written consent form before the test begins
|
|
| ExclusionCriteria |
| Details |
1.Subjects with a fasting blood sugar of greater or equal to 126 mg per dL, random blood sugar of greater or equal to 200 mg per dL, or patients with diabetes taking oral hypoglycemic agents or insulin 2.Subjects with glycated hemoglobin levels greater or equal to 6.5 percent 3.Subjects diagnosed with type 1 or type 2 diabetes 4.Subjects currently taking medications or dietary supplements related to diabetes 5.Subjects with clinically diagnosed chronic diseases 6.Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors 7.Subjects with uncontrolled high blood pressure 8.Subjects with a history of excessive alcohol consumption or substance abuse 9.Subjects with uncontrolled thyroid disorders 10.Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study period 11.Women of childbearing potential who are unable to use approved contraceptive methods 12.Subjects currently enrolled in another clinical trial or who have participated in a clinical trial within the past 30 days 13.Subjects with allergies to study-related interventions 14.Subjects with a history of significant adverse reactions to similar investigational products 15.Subjects who, in the judgment of the principal investigator, are unlikely to comply with study procedures or have conditions that could interfere with study completion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of the investigational product intake on lowering postprandial blood glucose via an oral glucose tolerance test compared to placebo |
Day 0, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of the investigational product on biomarker |
Day 0, Day 14 |
| To evaluate the effects of pharmacokinetic assessment |
Day 0, Day 14 |
| Overall Safety |
Day 0, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a double blind, placebo-controlled, randomized, cross-over study. The main objective of the study is to assess the improvement in postprandial blood glucose in prediabetic subjects following administration of the test product for 14 days. Subjects who fulfil the eligibility criteria will be enrolled into the study after signing the informed consent form. After the informed consent process, demographic surveys, medical history, medication usage assessments, details of prior and concomitant medications, physical measurements, vital signs will be evaluated. After passing the eligibility criteria, 36 subjects will be randomized into 2 treatment arms to receive either the IP or placebo. This will be followed by a wash-out period and then the subjects will be crossed-over to the alternate treatment . During both the treatment periods, anthropometric measurements will be taken.Blood samples will be collected for efficacy assessment. On the follow-up assessment visit, the subjects will have to come in fasting and consume the test product only at the study center. The subject diary shall be provided to the subjects to record the study IP administration, side effects, and concomitant medication details during the study duration. All subjects shall be instructed to complete the subject diary after each study IP administration. The study will be conducted in 5 visits over a period of 6 weeks. |