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CTRI Number  CTRI/2021/02/031551 [Registered on: 25/02/2021] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   efficacy and safety of probiotic butter spread (probiotic food) 
Scientific Title of Study   A Randomized, double-blind, placebo-controlled comparative clinical trial to evaluate the efficacy and safety of Probiotic Butter Spread (Probiotic Food) in Healthy Adult Subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00738 Version: 01, Dated 05 Feb 21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549


GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Patel 
Designation  Associate Director Consumer Research 
Affiliation  Cliantha Research  
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Zydus Wellness Limited  
Address  Zydus Wellness Limited House No 2 3 4 and 5 Sigma Commerce Zone Near Iskcon Temple S G Highway Ambli Bopal Road Ahmedabad 380015  
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  Cliantha Research   Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549
Ahmadabad
GUJARAT 		 9909013286
07966219549
nkpatel@cliantha.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Riddhi Medical Nursing Home Institutional Ethics Committee  Approved 
Riddhi Medical Nursing Home Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male and female subjects of age 18 to 60 years (both inclusive) at the time of consent having borderline high LDL cholesterol levels i.e. ≥ 130 mg/dl and ≤ 160 mg/dl will be included in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Probiotic butter spread (Probiotic Food)   20g Probiotic Butter Spread is having 14g fat, 9g Saturated fat, 4 g of MUFA, 0.66g PUFA, 0.25g Tans fat, 31.4 mg cholesterol, 157 mg sodium. It is also enriched with vitamins A, D2 and E 
Comparator Agent  Standard Normal Butter  Standard Normal Butter 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age: 18 to 60 years (both inclusive) at the time of consent.
2. Sex: Males and Non-pregnant/Non-lactating Females (preferably equal numbers of males and females).
3. Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit and agree to follow an accepted method of birth control for the duration of the study.
4. Stable weight (+/- 3 kg) for the last 3 months.
5. Subjects with BMI >18.4 and <25.0 kg/m² Normal to Overweight, as per Asian BMI guidelines will be included in the study.
6. Subjects with ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed.
7. Subjects willing to follow all study instructions and report to facility for all scheduled study visits.
8. Subjects with borderline high LDL cholesterol levels i.e. ≥ 130mg/dl and ≤ 160 mg/dl.
9. Subjects using a refrigerator for food storage and willing to store the product in a temperature controlled environment.
10. Subjects willing to provide blood, urine and stool samples as per study requirements.
11. Subjects willing to stay facility one day prior to study visit date to maintain overnight fasting state for every study visit.
 
 
ExclusionCriteria 
Details  1. Subjects who admit to using any of the following drugs within the last 6 months:
a. Antibiotics, anti-microbial agent, steroids, anti-Inflammatory or drugs for IBD
b. Lipid lowering drugs
c. Drug that suppresses gastric acid or alters gastrointestinal motility
d. Cytokines
e. Immunosuppressive cytotoxic agents
f. Habitual consumers of antacids and laxatives
g. Commercial Probiotic consumed in form of capsules etc. on regular basis
2. Subjects having history of a gastrointestinal, vesicular or pancreatic disease.
3. Subjects with history of surgery of the gastrointestinal tract in the last 12 months.
4. Subject who are known Diabetic.
5. Subjects who admit to drinking more than 3 glasses of alcohol a day.
6. Subject who are having any condition of immunosuppression including HIV.
7. Subjects with known Cardiovascular Complications, including high Blood pressure.
8. Subjects with impaired renal function identified by serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female.
9. Subjects with history of any inter-current illness in the last 8 weeks.
10. Clinical evidence of active liver disease or serum alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN).
11. Female subjects who are Pregnant or lactating women.
12. Any individual who is staff and / or who is involved with conduct of this study.
13. Subjects who have participated in another study with any investigational product within 3 months of randomization.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Efficacy and safety on gut flora (% abundance of various bacterial phyla, families, genera and species with L. rhamnosus and L. reuteri separately)
2. Effect and safety on serum inflammatory markers [hs-CRP]
3. To assess the effect on mean % change in immunity markers by measuring NK cell activity.
4. Efficacy and safety on Blood lipid profile characteristics
5. Effect of Test products on blood parameters, change in Hematology, Liver Function Tests, Renal Function Tests.
 		 1. After 43 days of treatment from baseline and between both arms.
2. Day 1 to 43 Days of treatment and between both arms.
3. Day 1 to 43 Days of treatment and between both arms.
4. Day 1 to 43 Days of treatment and between both arms.
5. On Screening Visit and Day 43
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Subjects tolerance to the test products [i.e. Flatulence, bloating, burp, rumbling, cramps, nausea, stool frequency, and stool consistency]. This will be measured on a 5-point Likert Scale by subject self-assessment questionnaire
2. Efficacy of test product on quality of life (QoL)
3. To assess the subjects perception about test product.
4. Safety of test product will be determined by adverse event, if any, reported by the Principal Investigator along with self-reported by subjects.
 		 1. Day 1 to 43 Days of treatment and between both arms.
2. Day 1 to 43 Days of treatment and between both arms.
3. Day 43
4. Day 1 to Day 15, Day 29 and Day 43
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2021 
Date of Study Completion (India) 16/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="13" 
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 rationale of the study is the efficacy and safety evaluation of Probiotic butter spread (Probiotic Food) in comparison to Standard Normal Butter. This evaluation will be carried out in subjects with borderline high blood lipid levels, to observe Probiotic response on serum lipid profile, gut health, immune marker, and serum inflammatory marker in healthy subjects with high borderline blood lipid levels.

 
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