Protocol summary

Summary
The aim of the present study is to come up with an appropriate chocolate formulation, using tagatose, galactooligosacharide and stevia and evaluation of its physico-chemical, rheological and sensory properties. Sensory evaluation of the present study is a single-blinded trial from which, subjects with a cold will be excluded. 10 panelists will be recruited. The subjects will consume 20 grams of conventional chocolate prepared with 50% sucrose, 30% cocoa butter and 20% cocoa mass. After 10 minutes of interval and rinsing their mouth with a glass of water, panelists will be provided with 20 grams of a chocolate so similar to the conventional type regarding the chemical structure, except that 5% of the total weight is replaced by a mixture of tagatose, galactooligosaccharide and stevia. Special questionnaires evaluating sensorial characteristics of the chocolates including flavor, taste, after taste, mouth feeling and general acceptance of the sample will be filled in instantly by the participants, after consuming each chocolate. Sensory evaluation will be performed just once for each subject.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112205554N4
Registration date: 2012-03-24, 1391/01/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-24, 1391/01/05
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
2012-02-14, 1390/11/25
Expected recruitment end date
2012-03-15, 1390/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of physical, chemical and rheological properties of chocolate prepared with D-tagatose, galactooligosaccharide and stevia and sensory evaluation of the very chocolate in healthy subjects, and comparing the results to those of conventional chocolate available in the market
Public title
Effect of D-tagatose, galactooligosaccharide and stevia on properties of chocolate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : not having a cold Exclusion criteria : having a cold
Age
From 10 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad Ave
City
Tabriz
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
90102

Health conditions studied

1

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

Primary outcomes

1

Description
Acceptance of the sample
Timepoint
Right after consumption
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
20 grams of conventional chocolate available in the market
Category
Prevention

2

Description
20 grams of chocolate containing 5% tagatose, galactooligosachharide and stevia added to achieve better texture
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Aziz Homayouni Rad
Street address
Attar Neyshapoori Avenue, Golgasht Street
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
Mohammadreza Rashidi
Street address
Golbad Street
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
Aziz Homayouni Rad
Position
Assistant professor/PhD in food science and nutrition
Other areas of specialty/work
Street address
Attar Neyshapoory Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1336 2117
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
Aziz Homayouni Rad
Position
PhD in food science and technology
Other areas of specialty/work
Street address
Attar Neyshapoory Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1336 2117
Fax
Email
homayounia@tbzmed.ac.ir; obakhtiari@yahoo.com
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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