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CTRI Number  CTRI/2013/12/004189 [Registered on: 05/12/2013] Trial Registered Retrospectively
Last Modified On: 25/11/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Preventive 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Evaluation of blood cholesterol lowering effect of a novel functional fermented betaglucan enriched oat bran/milk based drink. 
Scientific Title of Study   A Double Blind, Balanced, Randomized, Controlled Two-Way Cross Over Clinical Study To Evaluate The Blood Cholesterol Lowering Effect Of A Novel Functional Fermented Betaglucan Enriched Oat Bran/Milk Based Drink In Hyperlipidemic Adult, Human Subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akash Patel MD  
Designation  Principal Investigator 
Affiliation  Lambda Therapeutic Research Ltd. 
Address  Lambda Therapeutic Research Ltd., Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad

Ahmadabad
GUJARAT
380 061
India 
Phone  07940202020  
Fax  07940202021  
Email  akashpatel@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ketul Modi MBBS  
Designation  Co-Investigator 
Affiliation  Lambda Therapeutic Research Ltd. 
Address  Lambda Therapeutic Research Ltd., Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad

Ahmadabad
GUJARAT
380 061
India 
Phone  07940202020  
Fax  07940202021  
Email  ketulmodi@lambda-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr J B Prajapati  
Designation  Professor & Head 
Affiliation  Anand Agricultural University 
Address  Department of Dairy Microbiology, S.M.C. college of Dairy Science, Anand Agricultural University, Anand

Anand
GUJARAT
388110
India 
Phone  9879105948  
Fax    
Email  prajapatijashbhai@yahoo.com  
 
Source of Monetary or Material Support  
Lund University, Sweden 
 
Primary Sponsor  
Name  Swedish International Development Corporation agency 
Address  Lund University, Sweden 
Type of Sponsor  Government funding agency 
 
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 Akash Patel MD  Lambda Therapeutic Research Ltd.  Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad - 380 061 Gujarat, India.
Ahmadabad
GUJARAT 		 79-40202020

akashpatel@lambda-cro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Commitee-Aditya, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hyperlipidemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control treatment -R  Fermented milk based drink- 230 gm Twice daily for 28 days 
Intervention  Test treatment -T  A Novel Functional Fermented Betaglucan Enriched Oat Bran/Milk Based Drink - 230 gm Twice daily for 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  i. Non-smoking, hyperlipidemic, adult, human subjects between 18 and 70 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
ii. Having a Body Mass Index (BMI) between 20 and 30 (both inclusive), calculated as weight in kg/height in m2.
iii. Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (postero-anterior view).
iv. Able to understand and comply with the study procedures, in the opinion of the investigator.
v. Subject must have a proper storage appliance (i.e. fridge) at home in working condition to store the IFP below 8° C.
vi. Able to give voluntary written informed consent for participation in the trial.
vii. Having serum cholesterol ≥ 200 mg/dl.
viii. Having LDL- cholesterol ≥130 mg/dl.
ix. In case of female subjects:
• Surgically sterilized at least 6 months prior to study participation;
Or
• If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
And
• Pregnancy test must be negative.
 
 
ExclusionCriteria 
Details  i. Known hypersensitivity to milk or any content of the Investigational food product.
ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
iii. Ingestion or Use of any medication (including herbal remedies) at any time in 14 days prior to first IFP administration. In any such case subject selection will be at the discretion of the Principal Investigator.
iv. Ingestion of anti-hyperlipidemic drug, plant sterol/stanols in the form of cholesterol lowering margarines type spreads or drinks (i.e Benecol, Becel or similar), diuretics or β-blockers or any other drug which in opinion of the PI has effect on lipid profile 14 days prior to receiving the first IFPv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
vi. Consumption of Grapefruits or its products within a period of 48 hours prior to receiving the first IFP.
vii. Smokers, or who have smoked within last six months prior to start of the study.
viii. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving first dose of investigational food product
ix. The presence of clinically significant abnormal laboratory values during screening.
x. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
xi. History or presence of psychiatric disorder
xii. A history of difficulty with donating blood.
xiii. Donation of blood (1 unit or 350 mL) or receipt of an investigational product or participation in a drug research study within 90 days prior to baseline day.
Note: If subject had participated in a study in which blood loss was ≤ 200 mL, subject may be enrolled 60 days after the last sample of previous study.
xiv. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
xv. A positive test result for HIV antibody.
xvi. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the first IFP. In any such case subject selection will be at the discretion of the Principal Investigator.
xvii. Nursing mothers (females).
xviii. Having Serum Triglyceride above 354 mg/dl.
xix. Blood pressure more than 160 mmHg and 95 mmHg for the systolic and diastolic respectively at the time of screening.
xx. History of presence of Glucosurea
xxi. A history of presence of coronary heart disease and/or a decompensatio cordis of cardiomyopathy.
xxii. History of serious malignancy and/or drug treatment for hyperlipidemia less than 05 year ago prior to the first IFP.
xxiii. Use of medication known to affect the efficacy parameter measured in the study.
xxiv. History of known gluten intolerance.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
LDL-Cholesterol  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Serum Cholesterol, HDL- Cholesterol, Plasma Fasting Glucose, Triglyceride, Apoliprotein A1 and B, LDL-C/HDL-C ratio, Apo B/Apo A1 ratio, glycosylated haemoglobin (HbA1C), High sensitivity C-reactive protein (hsCRP), Faecal microflora (Lactobacillus and Bifidobacterium spp)  28 days 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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   N/A 
Date of First Enrollment (India)   16/08/2013 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a double blind, balanced, randomized, controlled two-way cross over trial to evaluate the blood cholesterol lowering effect of a novel functional fermented Betaglucan enriched oat bran/milk based drink administered 460 g daily for three months in 38 patients with hyperlipidemia that will be conducted in Ahmedabad, India. The primary outcome measures will be parameters such as Serum Cholesterol, HDL- Cholesterol, Plasma Fasting Glucose, Triglyceride, Apoliprotein A1 and B, LDL-C/HDL-C ratio, Apo B/Apo A1 ratio, glycosylated haemoglobin (hba1c), High sensitivity C-reactive protein (hscrp) and Faecal microflora (Lactobacillus and Bifidobacterium spp) at every 28 days.

 
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