This study aimed to determine the effect of Cinnamon (Cinnamon chromium) powder on body composition and chemical bio-markers of diabetic patients type 2 divided to body mass index, with the hypothesis that cinnamon is more effective
in diabetic patients with high body mass index than those with a low body mass index. Among diabetic patients of Yazd diabetic center, 120 patients with type 2 diabetes who did not have any complication of diabetes with a BMI between 18.5 and 40 will be enrolled. For all patients physical activity questionnaire, food frequency and mezaj questionnaires will be completed. fasting blood glucose ,HB (A1C), cholesterol, triglycerides, LDL and HDL and 2 hours post prandial glucose will be measured. Anthropometric factors including body weight, body mass index, muscle mass percentage, fat mass percentage will be measured by digital scale (OMRON BF511). All patients will be randomly divided into two groups case group : treated with 500 mg capsules of cinnamon twice a day, The control group receive placebo capsules twice a day. Patients and researcher will be blinded to allocation.The treatment period is three months and all biochemical and anthropometric parameters will be measured at the end of the study. All data will entered into SPSS software and analyzed in two groups with high and low body mass index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031133015N1
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Roghayeh Zare
Name of organization / entity
Shiraz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 3242
Email address
stud5529941941@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cinnamon (Cinnamon chromium) powder on body composition and chemical bio-markers of diabetic type 2 patients based no the body mass index.
Public title
Effect of Cinnamon on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent to participate in the study; patients with type 2 diabetes; Patients who only use oral medications to control their blood sugar ;Lack of disease or complications of diabetes ; body mass index between 18.5 and 40 ; Patients with a fasting blood glucose between 126 to 250 milligrams per deciliter .
Exclusion criteria: People who change during the study their treatment to insulin ; Lack of regular use of oral capsules (including cinnamon or placebo) ;sensitivity to other diseases during the study drug ; Cancel participate on the study; patients with a BMI of less than 18.5 (thin) and patients with a body mass index over 40 (morbid obese)
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences, Shiraz, Iran
Street address
Zand avenue, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.SUMS.REC.1395.176
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
typeII,Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
at onset and after 3 months
Method of measurement
blood sample
2
Description
Glycosylated Hemogolobine
Timepoint
at onset and after 3 months
Method of measurement
blood sample
3
Description
2hours post parandial glougose
Timepoint
at onset and after 3 months
Method of measurement
blood sample
Secondary outcomes
1
Description
mezaj
Timepoint
onset
Method of measurement
questionary
2
Description
body activity
Timepoint
onset
Method of measurement
questionary
3
Description
calery intake
Timepoint
onset
Method of measurement
food frequency questionary
4
Description
triglyceride
Timepoint
at onset and after 3 months
Method of measurement
blood sample
5
Description
colstrol
Timepoint
at onset and after 3 months
Method of measurement
blood sample
6
Description
weight
Timepoint
at onset and after 3 months
Method of measurement
digital scale (OMRON BF511)
7
Description
body mass indwx
Timepoint
at onset and after 3 months
Method of measurement
digital scale (OMRON BF511)
8
Description
fat mass percentage
Timepoint
at onset and after 3 months
Method of measurement
digital scale (OMRON BF511)
9
Description
muscle mass index
Timepoint
at onset and after 3 months
Method of measurement
digital scale (OMRON BF511)
10
Description
hdl
Timepoint
at onset and after 3 months
Method of measurement
blood sample
11
Description
ldl
Timepoint
at onset and after 3 months
Method of measurement
blood sample
Intervention groups
1
Description
cinnamon powder cap 500 mg ,BD,for three months
Category
Treatment - Drugs
2
Description
placebo,cap 500 mg, BD , for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
khani Diabetes Center
Full name of responsible person
Roghayeh Zare
Street address
khani Diabetes Center ,Shahid Sadoghi Ave,Yazd,Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Postal Code; 71345-1978
City
Shiraz
Grant name
Grant code / Reference number
11229
Is the source of funding the same sponsor organization/entity?