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CTRI Number  CTRI/2024/08/072841 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of The Good Bug supplement in type 2 diabetes. 
Scientific Title of Study   Clinical validation of The Good Bug Glycemic Control and fiber supplementation on improvement in glycemic control, metabolic markers, and gut health in type 2 diabetic participants.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/011 Version 1.00, dated 05 June 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manohar KN 
Designation  Principal Investigator 
Affiliation  Sharada Medical Centre 
Address  OPD room no 8EM206, 2Cross, HRBR Block 1, Kalyana Nagar, Banaswadi

Bangalore
KARNATAKA
560043
India 
Phone  9845205822  
Fax  -  
Email  drmanohar_kn@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjana Sawant 
Designation  New Product Development Lead 
Affiliation  Seven Turns Pvt. Ltd. 
Address  The Good Bug, office no 204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West Mumbai

Mumbai
MAHARASHTRA
400013
India 
Phone  7506391852  
Fax  -  
Email  sanjana@seventurns.in  
 
Details of Contact Person
Public Query  
Name  Kaynat Mirajkar 
Designation  Lead Nutritionist 
Affiliation  Seven Turns Pvt. Ltd. 
Address  The Good Bug, office no 204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West Mumbai

Mumbai
MAHARASHTRA
400013
India 
Phone  9699384096  
Fax  -  
Email  kaynat@seventurns.in  
 
Source of Monetary or Material Support  
Seven Turns Pvt Ltd The Good Bug 204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West, Mumbai, Maharashtra 400013 
 
Primary Sponsor  
Name  Seven Turns Pvt Ltd 
Address  204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West, Mumbai, Maharashtra 400013 
Type of Sponsor  Other [Nutraceutical Marketing Company] 
 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  OPD room No-401 Fourth-floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1 sachet of Placebo A (1.8 g) + 1 scoop of Placebo B (8g) in 200 ml water  15 minutes before breakfast for 90 days with nutritional counselling and tracking. 
Intervention  1 Sachet of The Good Bug Glycemic Control (1.8 g) + 1 scoop (8g) The Good Bug Metabolic Fiber Boost  Both in 200 ml water, 15 minutes before breakfast for 90 days with nutritional counselling and tracking. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Male and females aged 30-45 years (both inclusive);2.Participants with glycated hemoglobin (HbA1c) levels 8 % to 11% (both inclusive);3.Participants diagnosed and treated for more than 6 months for type 2 diabetes;4.Participants on oral hypoglycemic (OHA) medication treatment alone or in combination with oral antidiabetic drugs (metformin and/or sulfonylureas only) in a stable dose for at least 3 months prior to randomization;5.Participants providing voluntary, written informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1.Presence of Type I diabetes Mellitus (T1DM);
2. Participants receiving insulin/other injectables, antidiabetic drugs including
1 (GLP-1) analogues, dipeptidyl peptidase 4 (DPP4) inhibitors, etc.) except for those specified in the inclusion criteria;
3. Severe diabetes-related complications at screening (i.e., end-stage diabeticn kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy, any neuro-motor conditions/neurogenic conditions);
4. Regular intake of any herbal phytoinsulin product, probiotics, prebiotics, or
antibiotics for 3 months prior to inclusion;
5. Previously diagnosed allergy to probiotics;
6. Gastrointestinal disorders including food allergy, gluten-sensitive
enteropathy, ulcerative colitis;
7. An uncontrolled cardiovascular or respiratory disease, an active malignant
tumor, chronic infections, chronic bowel disorders, including but not limited
to IBS;
8. Participant who had severe course of COVID-19 (extracorporeal membrane
oxygenation, mechanically ventilated);
9. Participants had undergone any surgical procedures within the previous six
months;
10. Participation in another clinical trial;
11. Pregnancy or lactation as well as women with childbearing potential not
taking adequate contraceptive precautions;
12. Participants with known renal and liver impairment;
13. Participants with a myocardial infarction or stroke within 6 months before
study enrolment;
14. Participants with a history of substance abuse, drugs, heavy use of alcohol,
and/or smoking;
15. Participants with neurological conditions;
16. Participants with diagnosed PCOD/ PCOS;
17. Any other clinical condition in the investigators judgment finds the study
participation unsuitable for the participant. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Changes in Glycated Hemoglobin (HbA1c) levels.
2. Changes in Fasting Plasma Glucose (FPG), postprandial plasma glucose (PPG),
fasting insulin levels, Homeostasis Model Assessment of Insulin Resistance
(HOMA-IR), and Homeostasis Model Assessment of Beta-Cell Function calculated (HOMA-B calculated).
3. Changes in Lipid Profile parameters (Total Cholesterol, LDL-C, HDL-C,
non-HDL-C, Triglycerides). 		 1. At screening and day 90 (end of the study).
2. At screening, day 30, day 60, and day 90.
3. At screening and day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of Body Mass Index (BMI)
2. Assessing Gut health using a Gastrointestinal Symptom Rating Scale
(GSRS) score.
3. Changes in the participant-reported bowel habits
4. Assessment of HRQOL-15D score (Health Related Quality of Life) will be
measured.
5. Assessment of medication adherence using the 8-item Morisky Medication
Adherence Scale (MMAS-8) administered.
6. Evaluation of sensory characteristics through organoleptic studies/sensory analysis.
7. Changes in glucagon-like peptide (GLP-1) levels. 		 1. At screening, day 30, day 60, and day 90.
2. At screening, day 30, day 60, and day 90.
3. At screening, day 30, day 60, and day 90.
4. At screening and day 90.
5. At day 30, day 60, and day 90.
6. At day 30, day 60 and day 90.
7. At baseline and day 90.
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/09/2024 
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="6"
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   The growing global epidemic of Type 2 Diabetes Mellitus (T2DM) necessitates innovative and comprehensive approaches to improve glycemic control and overall metabolic health. With 537 million adults affected worldwide and projections indicating a rise to 783 million by 2045, existing therapies often fail to achieve optimal glycemic control, underscoring the urgent need for novel interventions. Emerging evidence highlights the critical role of the gut microbiome in T2DM pathophysiology, where dysbiosis—characterized by reduced microbial diversity and a shift towards pro-inflammatory microbes—contributes to impaired short-chain fatty acid (SCFA) production, reduced incretin hormones, and increased gut permeability. These alterations exacerbate insulin resistance, glucose intolerance, and inflammation, creating a vicious cycle that complicates disease management. This study aims to clinically validate ’The Good Bug Glycemic Control and Fiber Supplementation’ by investigating its effects on glycemic control, metabolic markers, and gut health in T2DM participants. The proposed intervention leverages a synbiotic approach, combining selected probiotics (Lactobacillus acidophilus, L. reuteri, L. fermentum, Bifidobacterium bifidum) known to enhance insulin sensitivity, incretin levels, and reduce inflammation, with prebiotics (inulin, fructooligosaccharides, galactomannan) that promote SCFA production and slow glucose absorption. Additionally, addressing micronutrient dysregulation common in T2DM—including deficiencies in chromium, zinc, magnesium, and vitamins B9, B12, and D—is essential for improving insulin action and metabolic health. Furthermore, a comprehensive fiber strategy featuring ’The Good Bug Metabolic Fiber Boost,’ which includes glucomannan and Nutriose, is designed to enhance satiety, improve glycemic control, and increase insulin sensitivity. The potential impact of this multifaceted approach includes better glycemic control with reduced medication dependency, slower progression of diabetic complications, and a shift towards personalized, microbiome-centered T2DM management. By potentially reducing complication rates, this strategy could offer cost-effective long-term care. The significance of this study lies in testing a novel, integrated approach that targets the root causes of T2DM, potentially transforming clinical practice by establishing the gut microbiome as a primary therapeutic target. This could improve the quality of life for millions and alleviate the global healthcare burden associated with T2DM. Thus, the clinical validation of this innovative supplementation strategy represents a crucial step towards redefining T2DM management and offering new hope for better patient outcomes. 
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