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CTRI Number  CTRI/2022/05/042791 [Registered on: 24/05/2022] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Trial to investigate the Safety and Efficacy of the BugSpeaks based personalized diet on the patients with Hyperglycemia and Hyperlipidemia. 
Scientific Title of Study   A Prospective, randomized, Open Label study to evaluate the Safety and Efficacy of BugSpeaks based personalized nutrition on patients with Hyperglycemia and Hyperlipidemia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PRO2022/03/03 Version 2 dated 07th Apr 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Ambhore 
Designation  Consultant MD 
Affiliation  Shreya Clinic 
Address  Shreya Clinic 4 Om Shiv Nagar, Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462001
India 
Phone  9303109655   
Fax    
Email  sanjayambhore18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debojyoti Dhar 
Designation  Co-Founder and Director 
Affiliation  Leucine Rich Bio Pvt Ltd. 
Address  Department of Microbiome, 2nd Floor, Room No.18, Seshmahal Building, Vasavi Temple road, VV Puram, Bengaluru, Karnataka, India

Bangalore
KARNATAKA
560004
India 
Phone  9818395909  
Fax    
Email  ddhar@leucinerichbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukul Maurya 
Designation  Director- ProClin Research Private Limited  
Affiliation  ProClin Research Private Limited  
Address  ProClin Research Private Limited Plot # 1, Nevri Hills, Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462001
India 
Phone  07032802286   
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
Leucine Rich Bio Pvt Ltd. 
 
Primary Sponsor  
Name  Leucine Rich Bio Pvt Ltd 
Address  No.18, 2nd Floor, Seshmahal Building, Vasavi Temple road, VV Puram Bengaluru, Karnataka, India Pin – 560004 
Type of Sponsor  Other [Private Diagnostic Manufacturer and Supplier] 
 
Details of Secondary Sponsor  
Name  Address 
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 Sanjay Ambhore  Shreya Clinic  Shreya Clinic: 4 Om Shiv Nagar, Gufa Mandir Road, Lalghati
Bhopal
MADHYA PRADESH 		 9303109655

sanjayambhore18@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: Z724||Inappropriate diet and eating habits,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bug speaks personalized nutrition  A specialized personalized diet will be given to the subjects based on Bug Speaks. Bug speaks is a non-invasive gut microbiota profiling test which profiles the gut microbiota and provides personalized nutritional recommendation based on the gut microbiota. The total duration of the diet is 90 days. 
Comparator Agent  Routine Nutrition  The subjects will consume his normal routine diet for 90 days. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Men and women from 45 to 65 years.
2. Body Mass Index (BMI) ≥ 19 and < 40 kg/m2
3. Signed informed consent.
4. Free of infections at baseline
5. HbA1c more than or equal to 7% - 10% or LDL cholesterol more than or equal to 120 mg/dL.
6. Patient who agrees to follow personalized diet for 3 months.
7. Subject on stable dose of oral Hypoglycemic medication except Metformin for the past 3 months or lifestyle intervention.
8. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on stable dose for at least three months prior to screening visit. These medications will not be changed during intervention unless it is mandatory. 
 
ExclusionCriteria 
Details  Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1. Individuals with severe diseases (hepatic, kidney, cancer…).
2. Individuals with Chronic Intestinal Pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohns Disease).
3. Individuals with dementia, mental disease or low cognitive function.
4. Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or
immunosuppressants.
5. Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months.
6. Individuals treated with oral antibiotics during two weeks prior to the beginning of the study.
7. Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study.
8. Women that consume oral contraceptive.
9. Pregnant women or breastfeeding.
10. Individuals with intensive physical activity (> 2 hours, more than 3 times per week).
11. Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study.
12. Individuals with regular consumption (> 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheese…) and/or use of other prebiotics and not to accept suppress their consumption during the study.
13. Individuals with increased alcohol consumption >30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey, brandy, anise, etc.)
14. Individuals with regular use of laxatives (> 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.
15. Patients who have received tumor immunotherapy (such as PD-1/L1, CTLA4, etc.) in the past 1 month, and inflammatory factor modulators such as Ulinastatin.
16. Patients who have received organ transplantation or surgery planning in the past 6 months.
17. Patients who cannot take food or drugs due to coma or intestinal obstruction.
18. Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
19. Women subjects that are pregnant or lactating, or subjects (including male subjects) having a
pregnancy plan (including plans for sperm donation or egg donation) during the study period.
20. Patients who have participated in any other clinical study within 2 weeks prior to randomization.
21. The investigators conclude that the patient is not suitable for the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients showing clinical improvement in HbA1c levels.
2. Proportion of patients showing clinical improvement In Lipid Profile.
3. Improvement in Overall Gut Microbiota.
4.Proportion of Patients showing improvement in CRP.
5. Change from baseline interleukin 10 (IL10) 		 Time Frame for all: 0 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)
2.Change from baseline natural killer cells cytotoxicity potential. 		 1. Time Frame:
Throughout the study
2. Time Frame: 0 and 12 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/05/2022 
Date of Study Completion (India) 30/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Diet plays an important role in shaping the composition of the gut microbiota thereby influencing the host’s health status. Various diet forms are found to influence the specific compositional patterns of the gut microbiota. Gut microbiome is now area of interest worldwide relates to health of every human. In studies major factors responsible for change in gut microbiome in healthy person reported as per geographic location, age, lifestyle and diet. Gastrointestinal tract (GI) contains various types of microorganisms, collectively called as microbiome or microbiota. On the other words microbiome is the collection of genomes (contains all of the information needed to build and maintain that organism) from all the microorganisms found in a particular environment or specific area. Healthy Gut Microbiome helps in metabolism and energy regulation in humans. Alteration in these microbiomes due to change in habitat may lead to different changes in GI tract.
BugSpeaks is a non-invasive gut microbiota profiling test which profiles the gut microbiota and provides personalized nutritional recommendation based on the gut microbiota. Diet especially, personalized, may improve prophylaxis and can be thoughtfully administered to patients affected with Diabetes and NAFLD to accelerate recovery and improve clinical outcomes.

 
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