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CTRI Number  CTRI/2024/03/063507 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Clinical study of nutritional supplement Supply6 360 to improve gut health. 
Scientific Title of Study   A pilot clinical study to evaluate the safety and effectiveness of nutritional supplement Supply6 360 in improving gastrointestinal health and wellness. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/23-24/037,Version: 1.00; Dated, 12 January 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre 
Address  Lokmanya Medical Research Centre Fourth-floor OPD No 401-314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  Office No 501-514, Crossroads, Wakad,

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  clinical@mprex.in  
 
Details of Contact Person
Public Query  
Name  Mr Vaibhav Bhandari 
Designation  Director 
Affiliation  Kanari Nutrition Pvt. Ltd. 
Address  Office No. 22 5- 1, 4th Cross, N R Road, Bangalore, Bengaluru Urban

Bangalore
KARNATAKA
560002
India 
Phone  9900102270  
Fax  -  
Email  vaibhav@supplysix.com  
 
Source of Monetary or Material Support  
Kanari Nutrition Pvt. Ltd. Office at No 22 5- 1, 4th Cross, N R Road, Bangalore, Bengaluru Urban, Karnataka, 560002. 
 
Primary Sponsor  
Name  Kanari Nutrition Pvt. Ltd. 
Address  Office at No. 22 5- 1, 4th Cross, N R Road, Bangalore, Bengaluru Urban, Karnataka, 560002. 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Lokmanya Medical Research Centre and Hospital Fourth floor OPD No 401 314 B Telco Road Chinchwad Pune MAHARASHTRA
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 
Healthy Human Volunteers  Healthy Human Volunteers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Supply6 360 pack   Dissolve 10 grams one pack into 120 ml room temperature water. Mix well and consume before breakfast in the morning for 60 days. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Healthy male and females between 25-35 years of age both inclusive. 2.BMI between 18.5 – 29.9 kg/m2. 3.Subjects should self-report at least two of the following gastrointestinal symptoms: epigastric discomfort, heartburn, bloating, nausea, fullness in the stomach, abdominal pain, or anorexia. 4.Not consuming probiotics, prebiotics, etc. 5.Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. 
 
ExclusionCriteria 
Details  1.Participants with major abdominal surgery a history of inflammatory bowel disease or diverticular disease celiac disease allergic diseases including asthma psychiatric disorders and critical systemic illness as assessed by medical history appropriate consultations and laboratory tests
2.Actively having a gut infection
3.History of or complications from malignant tumors
4.Females who are pregnant and have a positive urine pregnancy test planning to be pregnant/lactating or not using reliable methods of contraception
5.Participants with heavy alcohol consumption or smoking or tobacco consumption
6.Any condition that could in the opinion of the investigator preclude the participants ability to complete the study or that may confound study outcomes. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the Gastrointestinal Symptom Rating Scale (GSRS) score  From screening visit to end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in lipid profile.
2.Changes in serum vitamin B12 and vitamin D3 levels.
3.Changes in fatigue severity score.
4.Changes in the levels of NAD+ (by ELISA) as an indicator of energy.
5.Percent responders to a reduction in requirement of rescue medication for gastric symptoms (at least 50% reduction in doses or medication events in a month).
6.Gut microbiota assessment. 		 From screening visit to end of the study 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   12/03/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 study of human gut microbiota has significantly expanded in recent years. The gut microbiota exerts an impact on the host’s metabolism, physiology, and the development of the immune system. The gut microbiota composition is influenced by various factors, including nutrition, age, host genetics, medicines, and lifestyle. Changes in the makeup and operation of the gut microbiota have a direct impact on human well-being and are crucial in the development of various diseases. In today’s fast-paced and modern world, people often find it challenging to engage in physical activity due to sedentary desk occupations. This lifestyle, paired with difficulties in accessing healthy meals, contributes to the ingestion of unhealthy (junk) food. As a result, these individuals may encounter gastrointestinal symptoms, such as pain in the upper abdomen, discomfort in the abdominal area, heartburn, nausea and bloating etc. In order to address this problem, a formulation that is enhanced with vitamins, minerals, and bioactive substances and intended to improve gastrointestinal health is needed. The current clinical trial aims to establish empirical evidence about the safety and efficacy of the Supply 6 360 sachet, which is formulated by virtue of the selection of ingredients, in treating gastrointestinal problems in adults.

 
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