Protocol summary
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Study aim
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This study 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.
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Design
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The 83 participants were recruited from the Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute. A total of 83 eligible participants were randomized into two groups using block randomization method. Stratified randomization was used to match participants based on gender (male/female) and BMI (25-29.9/ 30-34.9 kg/m²) into 4 block sizes
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Settings and conduct
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The participants were recruited from the Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences..
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Participants/Inclusion and exclusion criteria
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patients aged between 30 to 60 years of age with a body mass index (BMI) 25-34.9 kg/m², and HbA1C value higher than 7% were recruited for this study. The patients should have been diagnosed at least 2 years prior to the study.
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Intervention groups
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intervention (Cardamom) and placebo ( rusk powder) group.
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Main outcome variables
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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.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016042717254N5
Registration date:
2016-11-23, 1395/09/03
Registration timing:
registered_while_recruiting
Last update:
2019-08-26, 1398/06/04
Update count:
1
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Registration date
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2016-11-23, 1395/09/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research,Tehran University of Medical Sciences
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Expected recruitment start date
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2016-11-20, 1395/08/30
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Expected recruitment end date
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2017-03-20, 1395/12/30
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Actual recruitment start date
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2016-11-20, 1395/08/30
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Actual recruitment end date
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2017-07-20, 1396/04/29
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Trial completion date
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2017-07-20, 1396/04/29
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Scientific title
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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
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Public title
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The effects of green cardamom supplementation in type 2 diabetic patients
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion 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:
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.
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Age
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From 30 years old to 59 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
80
Actual sample size reached:
83
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using block randomization method, in which the assignment was done based on sex (male/female) and BMI (overweight/ obese). By using stratified randomization participants were matched based on sex and BMI into blocks. Therefore, the block size was 4. By using this method equal number of men and women as well as overweight and obese patients were assigned to green cardamom and rusk powder group. Random allocation sequence was generated by using Random allocation software: RAS. The allocation process of participants into cardamom and rusk powder groups was done by a third person who was not involved in the project directly.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study is a a randomized, double-blind, placebo controlled clinical trial. The capsules were labeled as A or B to be delivered to the subjects by a third person who was not involved in the project directly and had the job to make the supplements. All placebo capsules were placed close to cardamom capsules to take cardamom smell. For doing this, the supplements were safely capsulated. Then a person who was not involved in the study, packaged the two types of supplements in the plastic bags and placed them close together in a covered box. After one week the capsules were packaged in the small containers to be delivered to the subjects. It was tested to see if the placebo capsules took the smells.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-12-13, 1394/09/22
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Ethics committee reference number
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IR.TUMS.REC.1394.1388
Health conditions studied
1
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Description of health condition studied
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diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus
Primary outcomes
1
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Description
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FBS
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Timepoint
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Before intervention, after intervention
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Method of measurement
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KIT
2
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Description
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FPI
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Timepoint
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Before intervention, after intervention
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Method of measurement
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KIT
3
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Description
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Hg A1c
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
4
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Description
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lipid profile
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
5
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Description
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TAC
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
6
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Description
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SOD
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
7
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Description
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GPx
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
8
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Description
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MDA
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
9
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Description
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Sirt1
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
10
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Description
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Irisin
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
11
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Description
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VCAM
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
12
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Description
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CD-163
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Timepoint
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Before intervention, after intervention
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Method of measurement
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kit
13
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Description
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ADMA
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
14
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Description
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SBP
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Timepoint
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Before intervention, middle of intervention, after intervention
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Method of measurement
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mmhg by mercury manometer
15
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Description
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OX-LDL
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Timepoint
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Before intervention, after intervention
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Method of measurement
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KIT
16
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Description
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PON
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Timepoint
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Before intervention, after intervention
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Method of measurement
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KIT
17
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Description
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apo A1 - apo B
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Timepoint
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Before intervention, after intervention
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Method of measurement
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KIT
18
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Description
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ICAM
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
19
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Description
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NO
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
20
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Description
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TNF-alfa
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
21
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Description
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IL-6
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
22
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Description
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hsCRP
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Timepoint
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Befor intervention, after intervention
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Method of measurement
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Kit
23
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Description
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DBP
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Timepoint
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Befor intervention, middle of intervention,after intervention
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Method of measurement
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mmhg by mercury manometer
Intervention groups
1
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Description
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Green cardamom supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks
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Category
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Placebo
2
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Description
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placebo (flour breadcrumbs) supplements are prepared as 0.5 gram capsules. 2 capsule per meal (3 gram daily) should be consumed for 10 weeks
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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No decision has been made in this case
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When the data will become available and for how long
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access to data few months after results are published
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To whom data/document is available
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Data are available for researchers
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Under which criteria data/document could be used
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If Data are available it would be available for researchers
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From where data/document is obtainable
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Dr. Gity Sotoudeh
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What processes are involved for a request to access data/document
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No decision has been made in this case
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Comments
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