Protocol summary

Summary
Objectives: Type 2 diabetes mellitus (DM), is a disease with a rising prevalence in Iran that its incidence is mainly due to changed diets specially with high levels of sugar and fat. Nowadays there is an increasing tendency to low caloric natural foods. Stevia rebaudiana is a kind of natural sweetener with zero calorie having the sweetness of 300 times or more than that of sugar and on the contrary of artificial sweeteners it doesn’t lead to health problems. Because of very few diabetic dairy products in Iran, we sought to assess production of a diabetic chocolate milk prepared using Stevia. We will also use Inulin to enhance texture properties of chocolate milk and meanwhile have a prebiotic in our new functional food. Design: This study will be carried out in 6 treatments with 3 repetitions by Randomized Complete Block Design (RCBD). Stevia will be substitute with sucrose in three portions of sucrose to Stevia; 100:0 (as the control), 50:50 and 0:100. Inulin, in three levels of %2, %4 and %6, will be also added to the treatment using %100 stevia and no sucrose. Some physicochemical, rheological and sensory properties will be determined to investigate the effect of Stevia and Inulin application on quality of chocolate milk. Sensory evaluation will be performed by 8 trained and 8 untrained assessors. Untrained assessors will participate in the acceptance test to determine the acceptance of the new products by ranking scale. To detect the differences through the treatments, discrimination tests will be performed by trained assessors.The participants should be devoid of any kinds of diseases (especially a cold) and should not smoke. A written consent will be obtained from all the subjects prior to the intervention. Conduct and interventions: In every sensory test 250cc of each product will be presented to the assessors who will be unaware of the type of chocolate milk they consume each time. The samples will be taste in the day of production, after reaching to the refrigerator temperature (4°C). Because of exposing to the pasteurization process during the production procedure, there will be no microbial risk for assessors. Furthermore, inulin and stevia are two substances which are permitted by FDA to be used in food products. At the end, analysis of data will be carried out by ANOVA using SPSS software ver. 16.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106245554N3
Registration date: 2011-07-31, 1390/05/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-31, 1390/05/09
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
2011-07-21, 1390/04/30
Expected recruitment end date
2012-03-18, 1390/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Qualitative properties and sensory evaluation of dietary chocolate milk prepared using stevia sweetener in comparison with the conventional chocolate milk by healthy assessors
Public title
Comparison of some physicochemical, rheological and sensory properties of dietary chocolate milk prepared using stevia with conventional chocolate milk
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 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 8
Randomization (investigator's opinion)
Randomized
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
2011-06-19, 1390/03/29
Ethics committee reference number
9018

Health conditions studied

1

Description of health condition studied
healthy assessors
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sensory evaluation of the 6 treatments and comparing them
Timepoint
Exactly after the consumption of 250 cc of the product
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
250 cc of chocolate milk prepared using stevia
Category
Prevention

2

Description
250 cc of chocolate milk prepared using stevia and inulin
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aziz Homayouni Rad
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 Ave.
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 science
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 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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