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CTRI Number  CTRI/2023/05/052961 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to assess the effect of investigational product on gut health in overweight and obese adults 
Scientific Title of Study
Modification(s)  		 A randomized double blind placebo controlled parallel group study to assess the gut health effects of Heat-killed Post-biotics EF2001 & beLP1 in overweight and obese adults 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BR/221101/EFLP/GH , 2.0 , 06 December 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Srivastava 
Designation  Associate Director Clinical Development 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  02242172300  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr.Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Ms Henali Bhoir 
Designation  Project Lead 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  7738387606  
Fax    
Email  henali.b@vediclifesciences.com  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd.118- B Morya House Off New link road , Adarsh Nagar , Andheri west Mumbai 400053  
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt. Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Chaudhari  AIMS Hospital   P-72, Milap Nagar, MIDC, Dombivli East, 421203
Thane
MAHARASHTRA 		 7337422597

chaudhari.vineet@gmail.com 
Dr Bharat Jain  Dhanwantari Hospital  Dhanwantari Hospital, 339-c, Mudaliar Rd, next to Kaka Halwai, Porwal Metallica, Rasta Peth, Pune, Maharashtra 411002
Pune
MAHARASHTRA 		 8087448919

dr_bharatjain@rediffmail.com 
Dr Mahesh Thakare  Dr Thakare superspeaciality clinic   Dr. Thakare superspeaciality clinic S N PLAZA, Trimurti-Kamatwade Rd, opp. ESPALIER SCHOOL, near Trimurti chauk , cidco, Indranagri, Durganagar, Nashik, Maharashtra 422008
Nashik
MAHARASHTRA 		 7822821643

mahesh131090@gmail.com 
Dr Ketan Pakhale  Dr. Ketan Pakhale   Metabol lifestyle clinic for metabolic syndrome ,Central Bank & Ghatkopar, Metro station, 25,Sanskar Bldg, Lal Bahadur Shastri Marg, opp. Sarvoday Hospital, Ghatkopar West, Mumbai, Maharashtra 400086
Mumbai
MAHARASHTRA 		 9819704302

drketan.pakhale@metabolindia.com 
Dr Ksheetij Kothari  Dr. Kotharis Digestive and Liver care  City center, 2nd floor 205, opp Vaibhav complex, Above axis bank, hadapsar gaon, hadapsar, Pune Maharashtra-411028
Pune
MAHARASHTRA 		 9765180182

ksheetij.kothari@gmail.com 
DrRamesh Dargad  Dr.Ramesh Dargad Clinc  G-1/A Bldg, Mukund Nagar,Andheri Kurla Road, Andheri(E),Mumbai 400049
Mumbai
MAHARASHTRA 		 9820152828

rohitdargad@outlook.com 
Dr Namrata Modi  Life Care Hospital  Life care Hospital, mumbai-Agra Highway, Lekha nagar bus stop, Nashik,422009
Nashik
MAHARASHTRA 		 7045103821

namratamodi11@gmail.com 
Dr Chetan Patil  Muktai Hospital  Plot No.11, Opp Fame Adlabs, Shivaji Nagar, Nashik - Pune Rd, Samta Nagar, Nashik, Maharashtra 422001
Nashik
MAHARASHTRA 		 9822651494

patilchetan@yahoo.com 
Dr Kushal Bangar  Shree Ashirwad Hospital  C - 3, Shree Complex, Manpada Road, Opp. Mahavir Nagar, Dombivli - 421201
Thane
MAHARASHTRA 		 9545664884

drkushal.bangar83@gmail.com 
Dr Prasad Nikam  Surya Multispeciality hospital  Surya Multispeciality hospital, Surya arcade 2nd floor opposite Nimani Bus stand , Panchvati Nashik -422003
Nashik
MAHARASHTRA 		 9922999002

drprasadnresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Altezza Institutional Ethics Committee  Approved 
Altezza Institutional Ethics Committee  Approved 
Altezza Institutional Ethics Committee  Approved 
Lellavati Ethics Committee  Approved 
Muktai Hospital Ethics Committee  Approved 
Muktai Hospital Institutional Ethics Committee  Approved 
Navsanjeevani Hospital Ethic Committee  Approved 
Supreme Independent Ethic Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gastrointestinal Discomfort  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  beLP1 - more than equal to30 billion cells/day  One capsule per day after breakfast for 84 days 
Intervention  EF2001 - more than equal to 30 billion cells/day  One capsule per day after breakfast for 84 days 
Comparator Agent  Placebo  One capsule per day after breakfast for 84 days 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  -Male and female individuals with the age more than equal to 18 and less than equal to 45 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire Short Form (IPAQ-SF)
-BMI of more than 25 less than 35 kg per meter square
-Individuals with liver & renal function test values as defined below:
-Individuals with ALT, AST values ≤ 2 times of the upper limit of normal (ULN).
-Individuals with creatinine values ≤ 1.5 times of the upper limit of normal (ULN).
-Individuals with ALP values ≥ 38 and ≤ 126 U/L
-having at least two of the following five metabolic risk factors:
-Waist circumference more than 102 centimeter (40 inches) for men and less than 88 centimeter (35 inches) for women;
-Fasting triglycerides more than 150 mg per dL and less than 300 mg per d per L
-Blood pressure more than equal to 130 mm Hg (Systolic Blood Pressure) and/or less than equal to 85 mm Hg (Diastolic Blood Pressure)
-Fasting blood glucose more than equal to 100 mg per d per l
-Fasting HDL cholesterol level less than equal 40 milligrams per deciliter (men) or less than equal 50 milligrams per deciliter (women)
-History of mild to moderate gastrointestinal discomfort for at least last three months [Previous prescriptions would be mandatory]
-Individuals experiencing moderate-intensity gastrointestinal symptoms, evaluated based on the combined scores of two GSRS domains (dyspeptic syndrome and bowel dysfunction), falling within the range of more than equal to 15 and less than equal to 29 over the past two weeks. (The highest score out of two weeks’ GSRS scores will be taken into consideration for the study)
-Willing to complete all study procedures including study-related questionnaires and comply with study requirements
-Willing to abstain from other supplements or medication
-Ready to give voluntary, written, informed consent to participate in the study.
-No prohibited antibiotic usage within the last 30 days.
-History of stable weight over the last 6 months (<10 Percentage change)
-Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol 
 
ExclusionCriteria 
Details  Individual who smokes and consumes tobacco regularly.

Presence of unstable, acutely symptomatic, or life-limiting illness.

Individuals diagnosed with diabetes and are on active medication

FBG more than 125 mg/dl

Individuals diagnosed with hypertension and are on active medication.

Individuals with uncontrolled hypertension with systolic blood pressure more than equal to 150 and/or diastolic blood pressure more than equal to 100 mm Hg.

Individuals with neurological conditions causing functional or cognitive impairments

Individuals with a history or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subjects ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.


Individuals under use of any psychotropic medication within four weeks of screening and throughout the study.

Individuals under use of antibiotics or signs of active systemic infection at the time of screening. Treatment visits will be rescheduled to allow the subject to wash off the antibiotic for at least five days prior to any test visit.

Individual states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.

Individuals states they regularly consume probiotic supplements and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics

Exposure to any non-registered drug product within 3 months prior to the screening visit.

Unable/unwillingness to complete study specific diaries (digital/paper-based).

Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement.

Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.

Individual who reports alcohol intake as average of 3 or more servings per day.

Individuals with thyroid dysfunction as assessed by TSH more than equal to 0.4 or less than equal to 4.3 mIU/L.

Individuals state they have an allergy or intolerance to any ingredient in the study product or test meal.

Individual is deemed unsuitable for study based upon study physician assessment.

Individual is taking part in another clinical trial. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
Modification(s)  		 Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS)  Day 0 Day 42 & Day 84 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the impact of the IP from baseline as compared to placebo on the basis of  Day 42 & Day 84 
To assess the impact of the IP on
1. Change in Body Composition as will be assessed by DEXA.
2. Improved gut permeability as assessed by decrease in the levels of Lipopolysaccharide Binding Protein in plasma.
3. Improved glucose & insulin metabolism as assessed by the change in the HOMA-IR.
4.Improvement in the Immunomodulatory properties as assessed by changes in the levels of INF-γ in serum
5. Improvement in cytokine levels as assessed by the change in the levels of IL-6 in serum
6. Cytokine levels like IL-6.
7. Inflammation by assessing the levels of Tumor necrosis factor –alpha.
8. Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
9. Perceived Stress Scale .
10. Quality of life using Digestive Associated Quality of Life Questionnaire.
 		 Day 0, Day 42 & Day 84 
To assess the impact of the IP at day 84 from baseline on
1 Short Chain Fatty Acids (SCFA).
2 Gut microbiome diversity using metagenome NGS sequencing 		 Day 0 & Day 84
 
 
Target Sample Size
Modification(s)  		 Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "155"
Final Enrollment numbers achieved (India)="155" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 19/04/2024 
Date of Study Completion (India) 24/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight and obese individuals experiencing gut issues. 
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