The effects of green cardamom supplementation on blood pressure and endothelium function,blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1 and B and paraoxonase in type 2 diabetic patients
This study as a double-blind randomized controlled clinical trial aimed to determine the effects of green cardamom supplementation on blood pressure and endothelium function , blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1, B and paraoxonase in type 2 diabetic patients. Totally 80 patients are invited based on inclusion and exclusion criteria. Weight, height and blood pressure are recorded using a digital scale, stadiometer and mercury barometer, respectively. Patients are randomly divided into two groups of 40 people, including placebo group and green cardamom supplementation group for 10 weeks. Green cardamom and placebo (flour breadcrumbs) standardized supplements are prepared as 0.5 gram capsules. 2 capsule per meal should be consumed. A 24-hr recall questionnaire is completed in baseline, after 5 weeks and end of study. Physical activity is assessed using short-form IPAQ (International Physical Activity Questionnaire) at baseline and end of study. Also, 15 ml of blood from the brachial vein of patients are taken to measurement of serum factors at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042717254N5
Registration date:2016-11-23, 1395/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-11-23, 1395/09/03
Registrant information
Name
Gity Sotoude
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3333
Email address
gsotodeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of green cardamom supplementation on blood pressure and endothelium function,blood glucose indices, lipids, oxidant and anti oxidant parameters, sirtuin-1, irisin, oxidised LDL, apolipoprotein A1 and B and paraoxonase in type 2 diabetic patients
Public title
The effects of green cardamom supplementation in type 2 diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria
Men and women between the age of 30–60 years old who have confirmed diagnosis of type 2 diabetes for more than 2 years; last HbA1C value greater than 7 %; Body Mass Index (BMI) between 25 and 35 kg/m2; Lipid-lowering drugs more than 3 months
Exclusion criteria
Patients with any of the following criteria will be excluded:
being on insulin regimen; use of fibrat(PPAR alpha ligand); TZD (PPAR gamma ligand); Smoking or alcohol consumption at least once a week in the past month; consumption of (at least once a week) herbal supplements; antioxidant; Multivitamin-Mineral in the past 3 months; pregnant and lactating women; have any gastrointestinal disorder, hepatic or renal disease, inflammatory disease, thyroid problems; any Chang in diet during the past 3 months, Consumers of anticoagulants (warfarin , heparin), antiplatelet drugs (Plavix), suppressor CNS (benzodiazepines), barbiturates (phenobarbital), antidepressants; Consumption of less than 90% of supplements; Any change in the type and amount of hypoglycemic drugs
Age
From 30 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics committee of Tehran University of Medical Sciences
Street address
First of Qods, Keshavarz Beulvard
City
tehran
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.TUMS.REC.1394.1388
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
Before intervention, after intervention
Method of measurement
KIT
2
Description
FPI
Timepoint
Before intervention, after intervention
Method of measurement
KIT
3
Description
Hg A1c
Timepoint
Before intervention, after intervention
Method of measurement
kit
4
Description
lipid profile
Timepoint
Before intervention, after intervention
Method of measurement
kit
5
Description
TAC
Timepoint
Before intervention, after intervention
Method of measurement
kit
6
Description
SOD
Timepoint
Before intervention, after intervention
Method of measurement
kit
7
Description
GPx
Timepoint
Before intervention, after intervention
Method of measurement
kit
8
Description
MDA
Timepoint
Before intervention, after intervention
Method of measurement
kit
9
Description
Sirt1
Timepoint
Before intervention, after intervention
Method of measurement
kit
10
Description
Irisin
Timepoint
Before intervention, after intervention
Method of measurement
kit
11
Description
VCAM
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
12
Description
CD-163
Timepoint
Before intervention, after intervention
Method of measurement
kit
13
Description
ADMA
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
14
Description
SBP
Timepoint
Before intervention, middle of intervention, after intervention
Method of measurement
mmhg by mercury manometer
15
Description
OX-LDL
Timepoint
Before intervention, after intervention
Method of measurement
KIT
16
Description
PON
Timepoint
Before intervention, after intervention
Method of measurement
KIT
17
Description
apo A1 - apo B
Timepoint
Before intervention, after intervention
Method of measurement
KIT
18
Description
ICAM
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
19
Description
NO
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
20
Description
TNF-alfa
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
21
Description
IL-6
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
22
Description
hsCRP
Timepoint
Befor intervention, after intervention
Method of measurement
Kit
23
Description
DBP
Timepoint
Befor intervention, middle of intervention,after intervention
Method of measurement
mmhg by mercury manometer
Secondary outcomes
empty
Intervention groups
1
Description
Green cardamom supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks
Category
Placebo
2
Description
placebo (flour breadcrumbs) supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital endocrine clinic
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs. Rostamabadi
Street address
First of Qods St, Keshavarz Beulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Nutrition and Dietetics Faculty of Tehran Medical Sciences
Full name of responsible person
Gity Sotoudeh
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
No 44, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
City
Tehran
Postal code
Phone
+98 21 8895 5814
Fax
Email
Gsotodeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Dietetics Faculty of Tehran Medical Sciences
Full name of responsible person
Gity Sotoudeh
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
City
Tehran
Postal code
Phone
+98 21 8895 5814
Fax
Email
Gsotodeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and Dietetics Faculty of Tehran Medical Sciences,
Full name of responsible person
Gity Sotoudeh
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
Nutrition and Dietetics Faculty, Hojjatdoust alley, Naderi St, Keshavarz Beulvard
City
Tehran
Postal code
Phone
+98 21 8895 5814
Fax
Email
gsotodeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)