Determination of the effect of oral consumption of sesame oil on anthropometric, metabolic and oxidative stress markers of patients with type 2 diabetes
Design
A double-blind randomized clinical trial with 24 DM type 2 patients divide into intervention and control group
Settings and conduct
This randomized double-blind clinical trial will be performed in Kashan Shahid Beheshti hospital. Participants are DM type 2 patients divide into sesame oil (n=24) and control (n=24) group. The intervention period is 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: participants must be patients of type 2 diabetes and their diabetes have diagnosed at least 2 years ago
the age range of 30 to 70 years; have no change in anti-diabetic medication since at least 4 weeks before the start of clinical trial; have HGA1C higher than 7% and lower than 9%; patients must be similar in anti-diabetic and statin drugs
exclusion criteria: patients show the allergic reaction during intervention; medication changes; treatment shift to insulin; a significant change in physical activities; hyperthyroidism or hyperthyroidism; pregnancy or lactation.
Intervention groups
DM type 2 patients divide into sesame oil and control group (15 gram oil per day in both groups). The lab tests in each participant will be done before and after 8 weeks of intervention. Sunflower oil will be used for placebo group, to be the closest type of oil to sesame oil.
Main outcome variables
Blood pressure, blood sugar, LDL, HDL, Triglyceride, Cholesterol, Malondialdehyde, Total Antioxidant Capacity, Glutathione, C-reactive protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150920024103N2
Registration date:2020-07-04, 1399/04/14
Registration timing:prospective
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Sadegh Jafarnejad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
sjafarnejad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-25, 1399/05/04
Expected recruitment end date
2020-08-25, 1399/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral consumption of sesame oil on anthropometric, metabolic and oxidative stress markers of patients with type 2 diabetes
Public title
The effect of oral consumption of sesame oil on patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must be patients of type 2 diabetes and their diabetes have diagnosed at least 2 years ago ( FBG ≥125 mg/dl, (OGTT) ≥200 mg/dl, HbA1C ≥7 and blood sugar ≥200 mg/dl)
Have nearly similar economic and social situation
Have no change in anti-diabetic medication since at least 4 weeks before the start of clinical trial
Have HGA1C higher than 7% and lower than 9%
Patients must be similar in anti-diabetic and statin drugs
Patients should not be smoking and alcohol consumer
Exclusion criteria:
Patients show the allergic reaction during the intervention
Medication changes or treatment shift to insulin
Significant change in physical activities
Hyperthyroidism or hyperthyroidism
Pregnancy or lactation
Omega 3 Supplement consumption
Patients suffer from any type of inflammation, organs failure, Corticosteroids consumption and GFR rate under 30
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. For simple randomization, we are going to use "random digits table" in "Stat Trek" application.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. Participants who participated in the study consciously, and the researchers in this study are blind and unaware that each of either participants is in one of the placebo or intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.055
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Anthropometric measurements
Timepoint
Before and after intervention
Method of measurement
Height meters and weighing Scale
2
Description
Fasting blood sugar
Timepoint
Before and after intervention
Method of measurement
Laboratory kit
3
Description
Triglycerides
Timepoint
Before and after intervention
Method of measurement
Enzymatic kit
4
Description
High density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Enzymatic kit
5
Description
Low density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Enzymatic kit
6
Description
Cholesterol
Timepoint
Before and after intervention
Method of measurement
Enzymatic kit
7
Description
C-reactive protein
Timepoint
Before and after intervention
Method of measurement
ELISA kit
8
Description
Total antioxidant capacity
Timepoint
Before and after intervention
Method of measurement
Spectrophotometry
9
Description
GSH
Timepoint
Before and after intervention
Method of measurement
Spectrophotometry
10
Description
MDA
Timepoint
Before and after intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Insulin resistance
Timepoint
before and after intervention
Method of measurement
Elisa Kit
2
Description
Insulin sensitivity
Timepoint
Before and after intervention
Method of measurement
Elisa Kit
Intervention groups
1
Description
Intervention group: oral consumption of sesame oil, 15 gram/day during 8 weeks
Category
Treatment - Other
2
Description
Control group: oral consumption of sunflower oil , 15 gram/day during 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Mashallah Tabatabaei Zadeh
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
2
Recruitment center
Name of recruitment center
Akhavan hospital
Full name of responsible person
Mohammad Tobeiha
Street address
15 Khordad square. , Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
87159.1151
Phone
+98 31 5577 0000
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Qotb –e Ravandi Blvd., Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sadegh Jafarnejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715973449, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Fax
+98 21 8895 5742
Email
sjafarnejad@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sadegh Jafarnejad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd., Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
sjafarnejad@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Negin Amin
Position
master of science student in nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Email
neginamin93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available