| 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
|
|
|
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
|
|
|
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.
|