| CTRI Number |
CTRI/2025/01/079161 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the safety of GlucoSEB PB and its impact on metabolism and gut health in adults with diabetes |
|
Scientific Title of Study
|
A randomized, double blind, parallel, placebo-controlled study to evaluate metabolic health and gut microbiome in
presence of GlucoSEB PB in diabetic adults as integrative care. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsha Pamnani |
| Designation |
Consultant Endocrinologist |
| Affiliation |
Dr Harsha Pamnani |
| Address |
Ground floor, room no 2, h.no 41, Ashirwad medical, near GPO, opposite Hamidia Hospital, Bhopal
Bhopal MADHYA PRADESH 462016 India |
| Phone |
9934647468 |
| Fax |
|
| Email |
drharshapamnani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhijit Rathi |
| Designation |
Principle Scientist |
| Affiliation |
Advanced Enzymes Technologies limited |
| Address |
5th floor, A wing, Sun Magnetica, LIC, Service road, Louis wadi, Thane West
Thane MAHARASHTRA 400604 India |
| Phone |
9970092220 |
| Fax |
|
| Email |
akrathi@advancedenzymes.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mukul Maurya |
| Designation |
Director, Proclin Research private limited |
| Affiliation |
Proclin Research private limited |
| Address |
2nd floor, plot no 1, Nevri Hills, Gufa Mandir road, Lalghati
Bhopal MADHYA PRADESH 462030 India |
| Phone |
7032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Advanced Enzymes Technologies Ltd.
5th floor, A wing, Sun Magnetica, LIC, Service Road,
Louis Wadi, Thane West, Thane, Maharashtra, 400604 |
|
|
Primary Sponsor
|
| Name |
Advanced Enzymes Technologies Ltd. |
| Address |
5th floor, A wing, Sun Magnetica, LIC, Service Road, Louis Wadi,Thane West, Thane, Maharashtra, 400604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Harsha Pamnani |
Dr Harsha Pamnani Clinic |
Ground floor, room no 2, h.no 41, Ashirwad Medical, near GPO, opposite Hamidia Hospital, Bhopal Bhopal MADHYA PRADESH |
9934647468
drharshapamnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Charak Hospital, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GlucoSEB PB |
500mg, 2 capsules per meal
(lunch and dinner), oral route of administration, swallow as a whole with water just before
having meal, for 180 days |
| Comparator Agent |
Placebo |
500mg, 2 capsules per meal
(lunch and dinner), oral route of administration, swallow as a whole with water just before
having meal, for 180 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with less physical activity
2. BMI 18.5 to 35 Kg/m2
3. Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for
participation in the study.
4. Subjects taking stable medicine dose for past 3 months
5. Subjects who occasionally consume sweets
6. Subjects with fasting blood sugar level ≥130 mg/dL and HbA1c 7.0 to 11.0%
7. Subjects must have a history of diabetes for more than 1 year and have been on a stable medication regimen for at least the past 9 months
8. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating female.
2. Subjects with BMI greater than or equal to 35
3. Type I diabetic patients
4. HbA1c less than 7.0 and greater than 11.0%
5. Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP1 receptor agonists
(GLP1RA), and Insulin)
6. Patients with major chronic complications (including but not limited to) autoimmune disease,
inflammation, etc.
7. Organic insufficiency (cardiac, hepatic, renal, respiratory)
8. Use of food supplements specifically containing fibers or polysaccharides
9. Chronic smoking and alcohol intake
10. Allergy to the ingredients in the test product.
11. History of any surgery in the past 3 months.
12. Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any enzymes [prescription or over the counter (OTC)]. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180) |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180).
2. Change in fasting insulin (assessment on Day 1, Day 90 & Day 180)
3. Calculate- HOMA-IR score- fasting insulin (μIU per ml) X fasting glucose (mmol per L) divided by 22.5
a. beta-cell function (HOMA-beta)- [20 X Fasting insulin (microIU/mL)] divided by [Fasting glucose (mmol per L) – 3.5]
b. Disposition index (DI)- DI is equal to 450 divided by [(FPG)2 – (FPG X 3.5)]
c. Quantitative insulin sensitivity check index (QUICKI)- QUICKI is equal to 1 divided by [log (fasting insulin microIU per mL) plus log
(fasting plasma glucose mg per dL)]
4. Change in Lipid profile (assessment on Day 1, Day 90 & Day 180)- Quantification of TC, TG, LDL, HDL, VLDL |
180 days |
5. Change in anthropometric parameters (assessment on Day -1 to Day -7, Day 1, Day 90 & Day 180) - Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR), Body fat percentage
(BFP).
6. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1 & day 180.
7. Change in Gut microbiome (assessment on Day 1 & Day 180) - Microbiota analysis of subjects from test & placebo arm (randomly selected 5 subjects from each arm on Day 1).
8. Questionnaire based assessment - Hunger & satiety scale, 36-Item Short Form Survey Instrument (SF-36) on Day 1, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 105, Day 120, Day 135, Day 150, Day 165, & Day 180.
9. Liver & Renal safety (assessment on Day 1, Day 90 & Day 180)- Check levels of AST, ALT, hs CRP, BUN, total albumin & globulin. |
180 days |
10. CBC analysis on Day 1, Day 90 & Day 180, & vital sign measurement (assessment on every visit).
11. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or
paper record)
12. Tolerability- The tolerance of the product by participants assessments for any side effect such as
Nausea, Vomiting, Bloating, Abdominal cramps & heartburn experienced during the study. The tolerability will be evaluated by the intensity of each individual symptom on a validated 5-point Likert
scale (0-no problem, 1-mild problem, 2-moderate problem, 3-severe problem & 4-very severe problem)
13. Rate of incidence of AE & SAEs- Recording any adverse (AE) or serious adverse event (SAE) from
Day 1 to Day 180 |
180 days |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
03/02/2025 |
| 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="7" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
T2DM can be a long-term condition that requires extended blood sugar management: the combined approaches such as pharmacological, physical and, in recent years, therapeutic interventions directed at the microbiome are the most effective in managing it (Diagnosis and Classification of Diabetes Mellitus, 2013). While standard formulations which include insulin, metformin and SGLT2 inhibitors assist patients to manage their blood glucose levels, they rarely come without a fair share of side effects such as hypoglycemia, weight gain or gastrointestinal problems (Wilcox et al., 2020). They do not, however, resolve the underlying problems that lead to insulin resistance and β-cell dysfunction. For this reason, there has been a growing need to look for new and safer, and combined therapies that help not only control hyperglycemia but also treat underlying conditions, the imbalanced metabolic state (Cerf, 2013).The enzyme blend GlucoSEB PB can be a part of diabetic care regimen. The enzymes modulate carbohydrate metabolism while probiotics support in improving gut health. Numerous studies have reported that the gut microflora is closely related to body metabolism. An imbalance of intestinal microbiota, or dysbiosis, is one characteristic of T2DM that leads to metabolic dysregulation by causing insulin resistance, systemic inflammation and increased gut permeability (Hou et al., 2022; Wu et al., 2023; Xia et al., 2021). GlucoSEB PB consists of components that have gut microbiome targeted mechanisms primarily focused on enhancing metabolic parameters in patients with diabetes rather than solely targeting dysglycemia. The aim of evaluating GlucoSEB PB is described as follows:  Metabolic Health: The enzyme blend is useful in decreasing the glycemic index of consumed carbohydrates by controlling the free glucose into the bloodstream, thus lowering blood glucose levels after a meal. This might have special significance in avoiding glucose toxicity which is one of the factors that lead to insulin resistance. The manufacture of prebiotic fibers also helps in metabolic health by altering the gut microbiota which may increase insulin sensitivity and decrease systemic inflammation levels.  Gut Microbiome Modulation: Since there is a wealth of data associating gut dysbiosis and T2DM; promoting good gut bacteria through GlucoSEB PB is of particular interest. There are studies that support the use of Probiotics as adjunct therapy for blood sugar control and those that reduce inflammation and improve metabolic disease. Since GlucoSEB PB may promote a healthier microbiome, it may also have a wider effect on metabolic health other than dysglycemia. GlucoSEB PB treatment combines the benefits of targeting metabolic and gut health to diminish the ill effects caused due to diabetes. GlucoSEB PB is an advanced therapy that promises new avenues aimed at diabetes management. |