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CTRI Number  CTRI/2019/03/017953 [Registered on: 06/03/2019] Trial Registered Prospectively
Last Modified On: 20/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study different brands of blended edible vegetable oils in Hyperlipidemic, Pre-diabetic subjects with normal blood pressure. 
Scientific Title of Study
Modification(s)  		 Multicentric, randomized, four arm, double blind, parallel group study in adult hyperlipidemic, Pre‐diabetic and Normotensive subjects. 
Trial Acronym  SCR/022/SGO/2018 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Viral Shah 
Designation  Medical Director 
Affiliation  Medical Director 
Address  Spectrum Clinical Research Pvt. Ltd. 401 – Kshamalaya Building, 37-New Marine Lines,Mumbai

Mumbai (Suburban)
MAHARASHTRA
400020
India 
Phone  02240645100  
Fax    
Email  vshah@spectrumcr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaijayanti Gaikwad 
Designation  Medical Monitor 
Affiliation  Medical Monitor 
Address  Spectrum Clinical Research Pvt. Ltd. 401 – Kshamalaya Building, 37-New Marine Lines,Mumbai

Mumbai (Suburban)
MAHARASHTRA
400020
India 
Phone  02240645100  
Fax    
Email  vgaikwad@spectrumcr.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Ghosh 
Designation  Project Manager 
Affiliation  Project Manager 
Address  Spectrum Clinical Research Pvt. Ltd. 401 – Kshamalaya Building, 37-New Marine Lines,Mumbai

Mumbai (Suburban)
MAHARASHTRA
400020
India 
Phone  02240645104  
Fax    
Email  sghosh@spectrumcr.com  
 
Source of Monetary or Material Support  
Marico Limited, Rang Sharda, Krishnachandra Marg, Bandra Reclamation, Bandra (West), Mumbai – 400 050  
 
Primary Sponsor  
Name  Spectrum Clinical Research Pvt Ltd  
Address  Spectrum Clinical Research Pvt. Ltd. 401 – Kshamalaya Building, 37-New Marine Lines, Mumbai – 400020, Maharashtra, India. Tel: 91-22-40645104 Fax: 91-22-6615 5567  
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Haridas Upadya  Aadithya Adhikari Hospital  Irwin Road, Mysore-570001, Karnataka, India
Mysore
KARNATAKA 		 9880046375

dr.upadya123@gmail.com 
Dr Sudhir Bhandari  Bhandari Clinic & Research Center  D- 126, Krishna Marg, Bapunagar
Jaipur
RAJASTHAN 		 9829078844

drs_bhandari@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
JNUIMSRC Ethics Committee  Approved 
Mysore Clinical Research Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hyperlipidemic, pre-diabetic, normotensive adult subjects. 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Blended Edible vegetable oil Test blend 1 ( blend of rice bran oil and sunflower oil (7:3) with antioxidant)  Subjects will be provided with food prepared in blended edible oil (Test blend 1). Dose: 500ml/subject/month Frequency: Three times a day Duration: 90 days Route Of Adminitration: Oral  
Intervention  Blended Edible vegetable oil Test blend 2 ( blend of rice bran oil and sunflower oil with Vitamin & antioxidant )  Subjects will be provided with food prepared in blended edible oil (Test blend 2). Dose: 500ml/subject/month Frequency: Three times a day Duration: 90 days Route Of Adminitration: Oral 
Comparator Agent  Commonly consumed oil ( groundnut oil, sunflower oil, soyabean oil)  Subjects will be provided with food prepared in commonly consumed oil ( groundnut oil, sunflower oil, soyabean oil). Dose: 500ml/subject/month Frequency: Three times a day Duration: 90 days Route Of Adminitration: Oral 
Intervention  Palmolein Oil  Subjects will be provided with food prepared in Palmolein Oil. Dose: 500ml/subject/month Frequency: Three times a day Duration: 90 days Route Of Adminitration: Oral 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. LDL Cholesterol levels 130-189mg/dl (ATP III Guidelines)
2. Patient with body mass index of ≥23 kg/m2 and ≤30 kg/m2
3. Untreated Dyslipidemia
4. Willingness to maintain current activity levels and follow the prescribed
diet 
 
ExclusionCriteria 
Details  1. Use of oral or injected corticosteroids or anabolic steroids 3 months prior/during the study
2. Uncontrolled thyroidism
3. Poorly controlled hypertension (resting blood pressure ≥140 mm Hg systolic and/or ≥90 mm Hg diastolic)
4. Participants on Medication/ alternative medicine/special diets for weight loss
5. Current smoker
6. Women who are pregnant, lactating, or planning to become pregnant
7. Liver disorders
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of treatment on LDL-C levels in comparison with all four groups.  90 days from Baseline Visit. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of treatment on following parameters such as TC, TG, HDL, VLDL, oxLDL, hsCRP, HbA1C, Fasting & PP sugar Systolic & Diastolic BP, Mean Arterial Pressure, BMI,Waist Circumference & quality of life.  90 days from Baseline Visit. 
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
Final Enrollment numbers achieved (Total)= "236"
Final Enrollment numbers achieved (India)="236" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   08/03/2019 
Date of Study Completion (India) 07/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/11/2019 
Estimated Duration of Trial   Years="0"
Months="9"
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)?  

Brief Summary
Modification(s)  

A multicentric, randomized, four arm, double blind, parallel group study to evaluate the efficacy of Blended edible vegetable oils (Test Blend 1 and Test Blend 2) in comparison with commonly consumed oils (Control) in Hyperlipidemic, Pre‐diabetic, Normotensive adult subjects.

Subjects will be randomized to one of the four groups: 

Group I – Consuming food prepared in Test Blend 1 

Group II – Consuming food prepared in Palmolein oil (Control 1)

Group III – Consuming food prepared in commonly used oil (groundnut oil, sunflower oil, soyabean oil) (Control 2)

Group IV – Consuming food prepared in Test Blend 2

 

Subjects would be asked to accommodate their cooking oil consumption by 500 ml./person/month.

 
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