Protocol summary

Summary
The purpose of this study was to investigate the effect of cinnamon on reducing blood glucose in people who had glucose intolerance. We recruited 50 volunteers having glucose intolerance to undergo a three phase Oral Glucose Tolerance Test (OGTT), supplemented with 5g placebo (control OGTT), 5g cinnamon (Cinnamon OGTT) in the second phase, and 5g cinnamon 12 hours before OGTT (OGTT 12 hours before) in the third phase. Blood sugar levels were measured before and after the trial and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010265021N1
Registration date: 2011-02-18, 1389/11/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-02-18, 1389/11/29
Registrant information
Name
Mohammad Sahebalzamani
Name of organization / entity
Azad islamic university tehran medical branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2281 1045
Email address
szamani@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Tehran Medical Branch
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-04-06, 1389/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cinnamon on reduction of glucose intolerance patients' blood sugar
Public title
The effect of cinnamon on blood glucose
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having medical document in Firoozgar hospital, having glucose intolerance disease, not taking glucose reducing drugs, attending learning diet classes, age 40 to 55 years old, having consent Exclusion criteria: Moving to other places, presence of diabetes and liver or renal failure, presence of allergy to cinnamon
Age
From 40 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University Tehran Medical Branch
Street address
Tehran Medical Branch, Islamic Azad University, Khaghani St, Shariati Ave
City
Tehran
Postal code
19168
Approval date
2009-07-26, 1388/05/04
Ethics committee reference number
10677

Health conditions studied

1

Description of health condition studied
Glucose intolerance
ICD-10 code
E14, R73.0
ICD-10 code description
Unspecified diabetes mellitus, impaired glucose tolerance

Primary outcomes

1

Description
Blood sugar
Timepoint
Befor intervention, one week after intervention and again two weeks later
Method of measurement
Blood glucose Test mg/dl

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercurial blood pressure instrument

2

Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Blood test

3

Description
HDL
Timepoint
Befoer and after intervention
Method of measurement
Blood test

Intervention groups

1

Description
Cinnamon group : cinnamon in the amount of 5 gr in 500 mg capsules have been taken minimum every 5 days in three stages.
Category
Prevention

2

Description
Placebo group : placebo in the amount of 5 gr in 500 mg capsules have been taken minimum every 5 days in three stages.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine institute of Firoozgar hospital
Full name of responsible person
Dr. Iraj Heydare
Street address
Firoozgar st. Valedy st. Beh Afarin st. Karimkhan Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Maryam Safaee
Street address
Tehran Medical Branch Islamic Azad University, Khaghani St, Shariati Ave,
City
Tehran
Grant name
0
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Tehran Medical Branch
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
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Mohammad Sahebalzamani
Position
PhD Assistant Professor of Islamic Azad University Tehran Medical Branch
Other areas of specialty/work
Street address
Khaghani St, Shariati Ave
City
Tehran
Postal code
19168
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
m_szamani@yahoo.comm_szamani@iautmu.ac.ir
Web page address
iautmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Emergency
Full name of responsible person
Maryam Safaee
Position
Master of Nursing
Other areas of specialty/work
Street address
Jomhouri Ave.
City
Tehran
Postal code
1316793631
Phone
+98 21 6646 9994
Fax
+98 21 6646 0552
Email
pr@tehran115.ir
Web page address
www.tehran115.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Mohammad Sahebalzamani
Position
PhD Assistant Professor of Islamic Azad University Tehran Medical Branch
Other areas of specialty/work
Street address
Khaghani St, Shariati Ave
City
Tehran
Postal code
19168
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
m_szamani@yahoo.comm_szamani@iautmu.ac.ir
Web page address
iautmu.ac.ir

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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