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CTRI Number  CTRI/2025/01/079413 [Registered on: 24/01/2025] 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   Clinical trial study to investigate the safety of SucroSEB and SEB TG which affects the metabolism and gut health of diabetic adults 
Scientific Title of Study   A randomized, double blind, parallel, placebo-controlled study to evaluate metabolic health and gut microbiome in presence of SucroSEB and SEB TG and to determine their safety in diabetic adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AETL/CT/001/2024 Version no.1, dated 19-11-2024  Protocol Number 
 
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, Opp. 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 Ltd 
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 Pvt Ltd 
Affiliation  ProClin Research Pvt Ltd 
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  
Name  Address 
NIL  NIL 
 
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, Opp. Hamidia Hospital, Bhopal
Bhopal
MADHYA PRADESH 
9934647468

drharshapamnani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Charak Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
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 
Intervention  SEB TG  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 
Intervention  SucroSEB  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/beverages containing sugar. 6. Subjects with fasting blood sugar level greater than or equal to 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, GLP-1 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/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 Gut microbiome from baseline to end of treatment (assessment on Day 1 and Day 180)  180 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in HbA1c (assessment on Day -1 to Day -7, Day 90 & Day 180)
2. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180)
3. Change in fasting insulin (assessment on Day 1, Day 90 & Day 180)
4. Change in Lipid profile (assessment on Day 1, Day 90 & Day 180) - Quantification of TC, TG, LDL, HDL, VLDL
5. Change in anthropometric parameters (assessment on day -1 to -7, Day 1, Day 90 & Day 180) - Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR)
6. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1, & day 180.
7. Questionnaire based assessment - Hunger & satiety scale, 36-Item Short Form Survey Instrument (SF-36), VAS Scale for bowel movement 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 
180 days 
8. Liver & Renal safety analysis (assessment on Day 1, Day 90 & Day 180)- Check levels of AST, ALT, hsCRP, BUN, total albumin & globulin.
9. CBC analysis & vital sign check (assessment on Day 1, Day 90 & Day 180)
10. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or paper record), in accordance with complemented by a Tolerability Scale or Assessment to provide a structured evaluation of the products safety.
11. 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) 
180 days 
12. 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="45"
Sample Size from India="45" 
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)   31/01/2025 
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  

In the most recent studies, the research conducted emphasizes the importance of focusing on the interplay between the gut microbiome and metabolic control, particularly with attention on how it mediates glucose metabolism. T2DM may also be seen as a consequence of gut dysfunction, termed as gut dysbiosis, due to the imbalanced structure and functional diversity of the gut microbiota. It has also been shown that dysbiosis inclines the body towards having an increased state of inflammation along with insulin resistance and also elevated levels of gut permeability which combine to deteriorate the metabolic processes. Hence, several studies have pointed to the gut microbiome also as an important target for treating T2DM and improving metabolic health. This has opened up the avenue for combinatorial therapies using enzymes and probiotics that could affect carbohydrate metabolism in addition to targeting gut health.

Enzyme blends SEB TG and SucroSEB provide a unique combination of metabolic modulation and microbiome-oriented therapeutics that can be utilized as a metabolic therapy. SEB TG targets starch-like substances and produces slowly digestible oligosaccharides that can withstand rapid degradation within the intestine. These oligosaccharides, also promote the growth of intestinal bacteria thus exerting prebiotic effect. SucroSEB, on the other hand, hydrolyzes sucrose and would produce fibers; thus, may be able to blunt postprandial blood glucose responses and further aid the gut microbiota. These formulations aimed at reducing dysglycemia would enhance indicators of the metabolic syndrome and the normal function of the gut microbial structure.

The SEB TG and SucroSEB are being evaluated under the consideration that these formulations may be included in the therapy of patients with diabetes for two main reasons: Improvement of Metabolic Parameters: The SEB TG and SucroSEB supplementation would reduce the glycemic index of the offending carbohydrates as these ingredients retard carbohydrate digestion and control discharge of free glucose into blood circulation. This dietary modification should help to lower post prandial glucose elevations, which would help protect against glucose toxicity, one of the main causes of insulin resistance. In addition, there is evidence supporting the production of prebiotic fibers from enzymatic action (under in-vitro conditions) that would enhance insulin sensitivity, normalizes hepatic glucose output, and decrease inflammation, all of which are essential for sustaining metabolic balance. Modulation of the Gut Microbiota: The emergence of links between gut dysbiosis and T2DM has consolidated the view that maintaining a healthy microbiome is essential for improving metabolic health. SEB TG and SucroSEB would promote the growth of good bacteria in the intestine by incorporating prebiotic fibers that help in balancing glucose metabolism and insulin sensitivity. Furthermore, these enzymes, by promoting a healthy gut microbiota, may lower systemic inflammation and promote gut barrier function thereby reducing the negative impact of hyperglycemia.

Given their role in regulating metabolism plus the microbiome health, these enzymes can serve as a new treatment option for patients suffering from T2DM. These enzymes not only tackle dysglycemia but also the causative dysbiosis, which renders them ideal for diabetes management. The current clinical trial seeks to evaluate the biological functions of SEB TG and SucroSEB while investigating their capacities to alter the gut microflora, enhance glucose metabolism and reinforce health and wellness in general. In this dual approach SEB TG and SucroSEB create new opportunities to enhance metabolic effectiveness and prevent long-term diabetes related complications.

 

 
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