Protocol summary

Summary
Randomly allocation of individuals into 5 separate groups including intervention groups consuming 3 cups of tea with 3 gram Cinnamon daily, 3 cups of tea with 3 gram Cardamom daily, 3 cups of tea with 1gram Saffron daily, 3 cups of tea with 3 gram Ginger, and control group only consumption of 3 cups of tea without any herbs mentioned above. Three weeks run-in period is considered before the intervention phase to make the similar samples as the tea consumption. Blindness is applied for the person who assesses the data. The herbs will be boiled with tea. The method of making tea will be explained for participants as the traditional method such as using tea-pot. The time for making tea is considered 10 minutes. Tea bags (Golestan brand)will be used. Herbs are prepared as grinded or powder for participants. This study will last 8 weeks. Demographic characteristics, weight, height, body mass index (BMI), waist circumference, blood pressure, body fat mass, fat-free mass are measured for each individual. Weight, blood pressure, fat mass and fat-free mass will assess again at the end of the study. To determine the effects of herbs on endothelial function indices, glycemic control, lipid profile, markers of oxidative stress and inflammation, a fasting blood sample will collect. Assessment of physical activity via a valid (content validity) questionnaire and assessment of compliance of individuals, via a 5 day dietary records in the beginning and end of the study will considered.

General information

Acronym
Diabetes and herbs
IRCT registration information
IRCT registration number: IRCT201206185062N5
Registration date: 2012-11-28, 1391/09/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-28, 1391/09/08
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran National Science Foundation
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cinnamon, Cardamom, Saffron and Ginger consumption on markers of endothelial function, glycemic control, lipid profile, oxidative stress and inflammation in type 2 diabetic patients
Public title
The effect of Cinnamon, Cardamom, Saffron and Ginger consumption on markers of endothelial function, glycemic control, lipid profile, oxidative stress and inflammation in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: type 2 diabetes patients, voluntary participation, age more than 30 years, body mass index more than 25 kg/m2, no injection of insulin, no other chronic diseases, not consumption of mentioned herbs. exclusion criteria: if patients do not want to continue the project or do not consume the herbs.
Age
From 25 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Isfahan University of Medical Sciences
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90003170

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
diabetes (mellitus)(nonobese)(obese):

Primary outcomes

1

Description
fasting blood glucose
Timepoint
the first day of the study and the last day of 8th weeks
Method of measurement
Elisa

Secondary outcomes

1

Description
serum triglyceride
Timepoint
the first day of the study and the last day of 8th weeks
Method of measurement
Elisa

2

Description
Intercellular Adhesion Molecule
Timepoint
the first day of the study and the last day of 8th weeks
Method of measurement
Elisa

3

Description
F2-isoprostan
Timepoint
the first day of the study and the last day of 8th weeks
Method of measurement
Elisa

4

Description
Interlukine-6
Timepoint
the first day of the study and the last day of 8th weeks
Method of measurement
Elisa

Intervention groups

1

Description
Control group: Only 3 cups of tea daily without any mentioned herbs
Category
Treatment - Drugs

2

Description
Intervention group A: 3 cups of tea with 3 gram Cinnamon daily
Category
Treatment - Drugs

3

Description
Intervention group B: 3 cups of tea with 3 gram Cardamom daily
Category
Treatment - Drugs

4

Description
Intervention group C: 3 cups of tea with 1 gram Saffron daily
Category
Treatment - Drugs

5

Description
Intervention group D: 3 cups of tea with 3 gram Ginger daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The endocrine and metabolism research center, Isfahan University of Medical Sciences. The screening
Full name of responsible person
Dr. Reza Ghiasvand
Street address
Department of Community Nutrition, School of Nutrition and Food sciences, Isfahan University of Medical Sciences
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr. Reza Ghiasvand
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
90003170
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medica
Full name of responsible person
Dr. Reza Ghiasvand
Position
PhD of Nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2742
Fax
+98 31 1668 2509
Email
ghiasvand@hlth.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Reza Ghiasvand
Position
PhD of Nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2742
Fax
+98 31 1668 2509
Email
ghiasvand@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Reza Ghiasvand
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2742
Fax
+98 66 82509
Email
ghiasvand@hlth.mui.ac.ir
Web page address

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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