Objective: Assessment of the effect of purslane seed on oxidative stress status in patients with type 2 diabetes. Design: Randomized cross over trial. Participants: Forty two diabetic patients who referred to Endocrinology and Metabolism Institute of Isfahan. Aged 35-65 years old; Non-smokers and lack of alcohol use; Not consuming supplements two weeks before the study and during the study; Non-pregnant and non-lactating women. No Change in dosage and type of medications at least two months prior to study; No history of chronic diseases. Exclusion criteria: Changes in diet or physical activity patterns for any reason; injection of Insulin during the study; Changes in dosage and type of medications throughout the study; Unwillingness to continue. Setting and conduct: Participants will be randomly assigned into two groups. Intervention group: will receive 10 gram powdered purslane seed with 240 cc low fat yogurt and control group: will use only 240 cc low fat yogurt for 5 weeks. Participants will move to the alternate arm after 2 weeks wash out period. The participants will be asked not to change their regular diet, medicine and activity during the study. To assess the compliance of the participants we will assess dietary intake of subjects by the use of dietary record once in every two weeks and Physical activity level will also be assessed by a physical activity record during the study. Main outcomes: biochemical measures including total antioxidant capacity (TAC), Serum malondialdehyde (MDA) and Serum oxidized LDL level. Outcomes will be measured at baseline and after each phase of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203241485N9
Registration date:2012-08-03, 1391/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-03, 1391/05/13
Registrant information
Name
Ahmad Esmaillzadeh
Name of organization / entity
Department of Nutrition, School of Public Health, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2791
Email address
esmaillzadeh@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-04-13, 1391/01/25
Expected recruitment end date
2012-06-14, 1391/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of portalaca olearaca on oxidative stress status in patients with type 2 diabetes: A cross-over study
Public title
Effect of portalaca olearaca on oxidative stress status in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non- Insulin dependent type 2 diabetic Patients; Non-smokers and lack of alcohol use; Not consuming supplements two weeks before the study and during the study; Non-pregnant and non-lactating women; Aged 35-65 years; No Change in dosage and type of medications at least two months prior to study; No history of hepatic, renal, lung, cardiovascular, kidney stone, thyroid diseases and gastro-intestinal bleeding; No history of myocardial infarction and stroke; Not affected by Severe non-proliferative or proliferative retinopathy; Not affected by malignant hypertension.
Exclusion criteria:
Change in diet or physical activity patterns during the study; injection of Insulin during study; Changes in dosage and type of medications throughout the study; Unwillingness to continue.
Age
From 35 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2012-03-10, 1390/12/20
Ethics committee reference number
190151
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Serum Malondialdehyde level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Commercial kits
2
Description
Serum oxidized LDL level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Commercial kits
3
Description
Total antioxidant capacity level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Commercial kits
Secondary outcomes
1
Description
fasting Plasma glucose level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Enzymatic method
2
Description
Weight
Timepoint
At baseline and after each phase of intervention
Method of measurement
Scale
3
Description
Waist circumference
Timepoint
At baseline and after each phase of intervention
Method of measurement
Un stretched measure
4
Description
Systolic blood pressure
Timepoint
At baseline and after each phase of intervention
Method of measurement
Mercurial sphygmomanometer
5
Description
Diastolic blood pressure
Timepoint
At baseline and after each phase of intervention
Method of measurement
Mercurial sphygmomanometer
6
Description
Serum Insulin level
Timepoint
At baseline and after each phase of intervention
Method of measurement
IRMA
7
Description
HOMA-IR
Timepoint
At baseline and after each phase of intervention
Method of measurement
Formula
8
Description
Serum triglyceride level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Enzymatic method
9
Description
Serum total cholesterol level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Enzymatic method
10
Description
Serum LDL level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Friedewald formula
11
Description
Serum HDL level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Enzymatic method
12
Description
Serum Apo A level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Immunoturbidimetry
13
Description
Serum Apo B level
Timepoint
At baseline and after each phase of intervention
Method of measurement
Immunoturbidimetry
Intervention groups
1
Description
Intervention group: Will receive 10 g/day of Purslane seed powder with 240cc low fat yogurt for 5 weeks
Category
Treatment - Other
2
Description
Control group: Will receive 240cc/day low fat yogurt for 5 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Institute of Isfahan
Full name of responsible person
Dr Ahmad Esmaeilzadeh
Street address
Endocrinology and Metabolism Institute of Isfahan, Khoram Street, Jomhoori Square, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Adibi
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Full name of responsible person
Elahe Zakizadeh
Position
Student of master degree of nutrition
Other areas of specialty/work
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2720
Fax
Email
e.zakizade.2010@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Full name of responsible person
Dr Ahmad Esmaeilzadeh
Position
PhD of Nutrition Sciences
Other areas of specialty/work
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2720
Fax
Email
esmaillzadeh@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan university of Medi
Full name of responsible person
Dr Ahmad Esmaeilzadeh
Position
Phd of Nutrition Sciences
Other areas of specialty/work
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2720
Fax
Email
esmaillzadeh@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)