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A comparison of effect of Soft Ice Cream formulated with Stevia, Date and Sugar on Blood Glucose of Healthy Volunteers

Protocol summary

Summary
This study is sought to compare the effects of Stevia, date fruit and sugar on blood glucose levels of healthy volunteers. Total of 10 healthy male and female adults aging between 19 and 35 will be invited to participate in the study. Those with any metabolic disorders including diabetes mellitus, hypertension, pregnancy, lactation, smokers and alcohol drinkers will be excluded. After an overnight fasting, the participants will be requested to consume 50, 61.5, 153.8, 76.9 grams of oral glucose, soft Ice Creams made with sugar, Stevia and date fruit in four different days, respectively. The blood glucose will be measured on 0, 15, 30, 45, 60, 90 and 120 minutes after intake of the oral glucose or the three Ice Cream formulations. Finally, glycemic index and load of the consumed products will be calculated.

General information

Acronym
INSDP
IRCT registration information
IRCT registration number: IRCT2012102811288N1
Registration date: 2012-12-10, 1391/09/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-12-10, 1391/09/20
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-02-11, 1392/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effect of Soft Ice Cream formulated with Stevia, Date and Sugar on Blood Glucose of Healthy Volunteers
Public title
Improving Nutritional Status of Diabetic Patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion Criteria:Male and females aging between 19-35; Non Impaired Glucose Tolerance; Agreement to participate in the Study Exclusion Criteria:Hypertention; Any metabolic disorder including Diabetes Mellitus; Pregnancy; Lactation; Smoking; Alcoholics
Age
From 19 years old to 35 years old
Gender
Both
Phase
N/A
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee for Research Ethics of Tabriz University of Medical Sciences
Street address
Committee for Research Ethics, No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah street,Tabriz PO Box :51664, Iran
City
Tabriz
Postal code
51664
Approval date
2012-10-15, 1391/07/24
Ethics committee reference number
91138

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test

Primary outcomes

1

Description
Blood Glucose
Timepoint
0,15,30,45,60,90,120
Method of measurement
mg/dl using the convetional biochemical method

Secondary outcomes

empty

Intervention groups

1

Description
They will be requested to consume 61.5 grams of Soft Ice Cream after 10 ten hours overnight fasting.
Category
N/A

2

Description
They will be requested to consume 153.8 grams of Stevia based after 10 ten hours overnight fasting.
Category
Treatment - Drugs

3

Description
They will be requested to consume 76.9 grams of date based Ice Cream after 10 ten hours overnight fasting.
Category
N/A

4

Description
They will be requested to consume 50 grams of oral glucose after 10 ten hours overnight fasting.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Street address
Department of Food Science & Technology, Faculty of Nutrition and Health, Ghol-Ghasht st.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Allahverdipour HamidRezaq
Street address
Dean Office, Faculty of Health and Nutrition,Tabriz University of Medical Sciences, Golgash St.
City
Tabriz
Grant name
بودجه دانشگاه
Grant code / Reference number
Not Applicable
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Health & Nutrition
Full name of responsible person
Mohammad Alizadeh
Position
Assistant Professor of Food Sciences & Technology , Ph.D., M.D.
Other areas of specialty/work
Street address
Department Of Food Science & Technology, Faculty Of Health, Gholghasht st.
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7313
Fax
+98 41 1334 4731
Email
mdalizadeh@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir

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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