Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000610831
Ethics application status
Not yet submitted
Date submitted
6/06/2012
Date registered
7/06/2012
Date last updated
7/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Probiotic cheese, chicory root extract and lipid profile
Scientific title
Effects of probiotic feta cheese and raw chicory root extract on lipid profile in healthy adult volunteers: a triple blinded randomized controlled trial
Secondary ID [1] 280630 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood lipids 286640 0
Condition category
Condition code
Diet and Nutrition 286924 286924 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1:
30 g Probiotic feta cheese containing Lactobacillus acidophilus LA5 and Bifidobacterium lactis BB12 with the dosage of 5 × 106 CFU to consume in the daily diet.


Extraction of a 30 g chicory root for daily consumption.

Method of administration: Participants were asked to slice the root, boiling it with 4 cups of water. After 15 min of boiling, the remaining water was the suitable extract participants had to consume as a drink.

Duration of consumption: 4 weeks

Arm2: Only the mentioned probiotic cheese without the chicory root extract. (All details same as Arm1).
Intervention code [1] 285026 0
Prevention
Comparator / control treatment
The control group recieved no treatment and was against the study intervention
Control group
Active

Outcomes
Primary outcome [1] 287280 0
at least 17% reduction in the blood cholesterol level.

Primary outcome method of measurement: Blood sample analysis - enzymatic method with Parsazmun kits (DiaSys, Germany)
Timepoint [1] 287280 0
Before the intervention and 4 weeks after the start of intervention.
Secondary outcome [1] 297812 0
Blood HDL increase.

Method of measurement: Blood sample analysis - direct Clearance method (Randox, UK)
Timepoint [1] 297812 0
Before the intervention and 4 weeks after the start of intervention.
Secondary outcome [2] 297813 0
Blood Triglyceride reduction.

Method of measurement: Blood sample analysis - enzymatic method with Parsazmun kits (DiaSys, Germany)
Timepoint [2] 297813 0
Before the intervention and 4 weeks after the start of intervention.
Secondary outcome [3] 297827 0
Blood LDL reduction.

Method of measurement: Blood sample analysis - enzymatic method with Parsazmun kits (DiaSys, Germany)
Timepoint [3] 297827 0
Before the intervention and 4 weeks after the start of intervention.
Secondary outcome [4] 297828 0
BMI reduction.

Method of measurement:
Body weight (in Kg) was measured with 0.1 Kg accuracy by Seca electronic flat scale (Model 813, Hamburg, Germany).

Heights of the subjects were measured by Seca mechanical measuring tape (model 206, Hamburg, Germany) with 0.1 cm accuracy.
Timepoint [4] 297828 0
Before the intervention and 4 weeks after the start of intervention.

Eligibility
Key inclusion criteria
Healthy condition, aged 18-65, not being lactose intolerance
and willingness to participate in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking, alcohol consumption during the study, pregnancy or breast feeding, being a professional athlete, taking supplements or any sort of drugs specially antibiotics, consumed any Probiotic product during the last month before the intervention start, having kidney or inflammatory intestinal diseases, having thyroid disorders, having any liver or immunodeficiency diseases.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained until the end of the study by using sequentially numbered, opaque, sealed envelopes (SNOSE) method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SAS version 9.2 (SAS Institute Inc, Cary, NC, USA) software will be used for randomization. Qualified participants will randomly assign into three groups at a 1:1:1 ratio. Stratified blocked randomization with the stratification factors sex, BMI and age, will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4349 0
Iran, Islamic Republic Of
State/province [1] 4349 0

Funding & Sponsors
Funding source category [1] 285396 0
Self funded/Unfunded
Name [1] 285396 0
Country [1] 285396 0
Iran, Islamic Republic Of
Primary sponsor type
Other
Name
Omega Research Team (ORT)
Address
Number 7-block 5-shahid Hashemi nejad-Lavizan
Tehran

Postal code: 1678813134
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 284249 0
None
Name [1] 284249 0
Address [1] 284249 0
Country [1] 284249 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287410 0
The university which the researcher are a member of does not include an ethics committee since it does not have a Medical School. It should be noted that all the standard ethical procedures about the human subject were completely considered.
Ethics committee address [1] 287410 0
Ethics committee country [1] 287410 0
Date submitted for ethics approval [1] 287410 0
08/06/2012
Approval date [1] 287410 0
Ethics approval number [1] 287410 0

Summary
Brief summary
Objectives: The purpose of current study is to evaluate the effect of Probiotic cheese and chicory root extract consumption on lipid profile during a 4 wk period. Design: It is a triple blinded parallel randomized controlled trial in Tehran, Iran. 30 volunteers aging 18 – 65 will participate. Participants will be randomly assigned into three 10-person balanced groups and consume 30 g Probiotic cheese containing Lactobacillus acidophilus LA5 and Bifidobacterium lactis BB12 with extract of 30 g raw chicory root, daily (intervention 1), 30 g of Probiotic cheese (intervention 2) and none of the above (control group). Fasting blood samples and anthropometric measurements will be collected in the beginning and after the consumption period at the Pathobiology Laboratory Center and SRBIAU Nutrition clinic, respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34277 0
Address 34277 0
Country 34277 0
Phone 34277 0
Fax 34277 0
Email 34277 0
Contact person for public queries
Name 17524 0
Shayan Mohammad Moradi
Address 17524 0
Number 7-block 5-shahid Hashemi nejad-Lavizan
Tehran

Postal code: 1678813134
Country 17524 0
Iran, Islamic Republic Of
Phone 17524 0
+98 912 3582980
Fax 17524 0
Email 17524 0
[email protected]
Contact person for scientific queries
Name 8452 0
Shayan Mohammad Moradi
Address 8452 0
Number 7-block 5-shahid Hashemi nejad-Lavizan
Tehran


Postal code: 1678813134
Country 8452 0
Iran, Islamic Republic Of
Phone 8452 0
+98 912 3582980
Fax 8452 0
Email 8452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.