Protocol summary
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Study aim
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The aim of this study is to determine the effects of bulk bread containing Portulaca Oleracea on lipid profile and blood sugar in patients with type 2 diabetes
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Design
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This study is a randomized clinical trial with parallel groups, without blinding, with 50 subjects in each group which evaluates the effect of portulaca on lipid profiles and fasting blood glucose levels in diabetic patients.
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Settings and conduct
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Among diabetic patients referred to diabetes clinic selected 100 patients and will be divided into two groups using quadruple blocks. The intervention group (50 patients) will receive the Portulaca Oleracea and the control group (50) will receive bulk without portulaca daily for 4 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : age range between 30-64 years old, Body Mass Index range between 19 and 35 kg per m2, diabetic patients referring to the diabetic clinic of Shahroud (or a known diagnosis of diabetes and to diagnose a physician) fasting blood glucose ≥ 125mg / dl
Exclusion criteria: Patients receiving insulin therapy; patients with cardiovascular, renal, hepatic, hematological, hypothyroidism and convulsion diseases; patients with a history of gallstones or gallbladder surgery; patients under estrogen, steroid, beta-blocker and thiazide therapy; women planning for pregnancy; pregnant women; breast-feeding women. The use of E and C supplements of omega 3 at least 6 months before sampling, smoking and narcotics as well as those who have not been used during two weeks of training.
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Intervention groups
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The intervention group included 50 patients will receive bread containing portulaca ( that has already been confirmed technically by its theological, physico-chemical and Sensory properties) and the control group included 50 patients receive bulk without portulaca daily for 4 weeks.
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Main outcome variables
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Lipid profile and blood sugar
General information
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Reason for update
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1. Add the duration of the intervention
2. Add more secondary outcome measures
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110309006010N1
Registration date:
2019-05-18, 1398/02/28
Registration timing:
prospective
Last update:
2020-03-27, 1399/01/08
Update count:
1
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Registration date
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2019-05-18, 1398/02/28
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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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Expected recruitment start date
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2019-06-08, 1398/03/18
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effects of bulk bread containing Portulaca Oleracea on lipid profile and glucose level in Type II Diabetes
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Public title
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The effects of bread containing Portulaca Oleracea on lipid profile and blood sugar in patients with type 2 diabetes.
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range between 30-64 years old,
Body Mass Index(BMI), range between 19 and 35 kg per m2,
Diabetic patients referring to diabetes mellitus (known as diabetes mellitus and clinician)
Fasting blood glucose ≥ 125mg / dl.
Exclusion criteria:
Patients receiving insulin therapy;
Patients with cardiovascular, renal, hepatic, hematological, hypothyroidism and convulsion diseases;
Patients with a history of gallstones or gallbladder surgery;
Patients under estrogen, steroid, beta-blocker and thiazide therapy;
Women planning for pregnancy; pregnant women; breast-feeding women.
The use of E and C supplements of omega 3 at least 6 months before sampling,
Smoking and narcotics as well as those who have not been used during two weeks of training,
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Age
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From 30 years old to 64 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After choosing patients according to inclusion and exclusion criteria and regarding the order of entry of them to this study, the envelopes in which groups A and B are selected from random numbers are opened and subjects allocated to intervention and control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2019-04-10, 1398/01/21
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Ethics committee reference number
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IR.SHMU.REC.1397.200
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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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Fasting Blood Sugar
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Timepoint
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At the beginning of the study, the end of the second and fourth week
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Method of measurement
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Blood glucose level will be determined in laboratory by commercial standard kit
2
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Description
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Triglyceride
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Timepoint
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At the beginning of the study, the end of the second and eight week
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Method of measurement
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Blood triglyceride level will be determined in laboratory by commercial standard kit
3
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Description
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(HDL) High-density lipoprotein
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Timepoint
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At the beginning of the study, the end of the second and eighth week
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Method of measurement
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Blood HDL level will be determined in laboratory by commercial standard kit
4
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Description
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Low-density lipoprotein (LDL)
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Timepoint
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At the beginning of the study, the end of the second and fourth week
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Method of measurement
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Blood LDL level will be determined in laboratory by commercial standard kit
Secondary outcomes
1
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Description
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weight
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Timepoint
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At the beginning of the study, the end of the second and eighth week
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Method of measurement
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Scale
2
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Description
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Waist circumference
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Timepoint
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At the beginning of the study, the end of the second and eighth week
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Method of measurement
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Irresistible meter
3
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Description
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Systolic blood pressure
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Timepoint
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At the beginning of the study, the end of the second and eighth week
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Method of measurement
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Mercurial sphygmomanometer
4
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Description
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Diastolic blood pressure
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Timepoint
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At the beginning of the study, the end of the second and eighth week
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Method of measurement
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Mercurial sphygmomanometer
5
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Description
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Liver Enzymes (Alanine Aminotransferase,Gamma-Glutamyl Transferase, Aspartate Amino Transferase) (AST, ALT, GGT)
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Timepoint
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At the beginning of the study, the end of the eighth week
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Method of measurement
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Pars Azmon Kit
Intervention groups
1
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Description
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"Intervention group: " included 50 patients will receive bread containing purple( that has already been confirmed technically by its theological, physico-chemical and Sensory properties) daily for 4 weeks
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Category
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Other
2
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Description
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"Control group: " included 50 patients receive bulk without purple daily for 4 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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Azad University
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Proportion provided by this source
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5
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Public or private sector
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Private
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It has not been decided at the moment and there are no more details at the moment
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available