Protocol summary

Summary
Due to bacterial resistance to antibiotics also outbreaks of intestinal diseases and colds among children and adult, scientists try to control these diseases by prevention. Probiotics are beneficial bacteria that live in human intestines and compete with pathogenic bacteria and strengthen the immune system have positive effects on host health. Ice cream, having a stable environment and stable conditions, the product is suitable for transferring probiotics to the host body, especially the soy ice cream in addition to the above features of the property is Functional food . This study considers the production of soy milk, ice cream and transfer between individuals to use probiotics. The fermentative production of probiotic soy ice cream the first ice cream mix prepared and then divided into two parts, one part bacteria (Lactobacillus casei 01) are added and allowed to ferment works to be done, sensory evaluation and comparison with the results of its control soy ice cream, the assessor uses 40 and the methods used to question letter. probiotic therapy in conjunction with a live review of cell culture in MRS agar pore plait method used be and to perform physicochemical tests , rheological and sensory National Iranian Standard No. 2450 to operate and if necessary, the standard AOAC 1997 to be taken.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202195554N6
Registration date: 2012-07-29, 1391/05/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-29, 1391/05/08
Registrant information
Name
Aziz Homayouni
Name of organization / entity
Tabriz University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 41 1231 3431
Email address
homayounia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-18, 1390/11/29
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of physicochemical, rheological, microbial and sensory properties of fermented probiotic soy ice cream
Public title
Assessment of physicochemical, rheological, microbial and sensory properties of fermented probiotic soy ice cream
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: not having any diseases (including a cold); not smoking exclusion criteria: having any diseases (including a cold); smoking
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Golbad Ave
City
tabriz
Postal code
5166614711
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
9160

Health conditions studied

1

Description of health condition studied
Healthy subjects
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Assessment of sensory properties of fermented probiotic soy ice cream and soy ice cream and comparing them
Timepoint
Exactly after the consumption of each kind of ice cream
Method of measurement
Hedonic system (questionnaire)

2

Description
Evaluation of physicochemical and rheological propertie probiotic ice cream prepared by fermentation of soy milk
Timepoint
After the initial mixture and cream production
Method of measurement
Using the standard commands No2450

3

Description
Assess the viability of probiotic bacteria, Lactobacillus casei in fermentation product of soy milk in ice cream
Timepoint
Immediately before and after the production and after 7,14,21,28,60,90,120,150,180 days
Method of measurement
pore plait method in MRS medium

Secondary outcomes

empty

Intervention groups

1

Description
One hundred grams of fermented probiotic soy ice cream will be given to each volunteer for sensory evaluation only once
Category
Prevention

2

Description
One hundred grams of soy ice cream will be given to each volunteer for sensory evaluation only once
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golbad st, tabriz,East Azarbaijan , iran
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aziz Homayouni Rad
Position
Assistant Professor, Department of Food Science and Technology
Other areas of specialty/work
Street address
Attar Neyshabouri Street, Golgasht Street
City
tabriz
Postal code
5166614711
Phone
+98 41 1335 7581
Fax
Email
Homayounia@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aziz Homayouni Rad
Position
Assistant Professor, Department of Food Science and Technology
Other areas of specialty/work
Street address
Attar Neyshabouri Street, Golgasht st
City
tabriz
Postal code
5166614711
Phone
+98 41 1335 7581
Fax
Email
Homayounia@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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