Assessment the ellagic acid supplementation effect on glycemic status, insulin resistance, inflammatory factors, antioxidant status and expression of miR146-a in patients with type 2 diabetes: double blind randomized clinical trial
Improving glycemic status, insulin resistance, antioxidant status and inflammatory factors in patients with type 2 diabetes
Design
In this study, 44 patients with type 2 diabetes who are eligible for inclusion in the study and referred to the Department of Endocrinology and Metabolism of Velayat Hospital of Qazvin University of Medical Sciences are selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code.
Settings and conduct
This study will be done by referring to the Specialty Hospital of Qazvin University of Medical Sciences. The intervention and control group will receive 200 mg of ellagic acid or placebo daily for 2 months, respectively. Each person will complete questionnaires of consent, individual, physical activity, and 24-hour recall. Fasting blood samples were also collected at the beginning and end of the study in 10 ml from participants. In this study, participants will be randomly divided into two groups (22 persons) through the table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to work, type 2 diabetes, age 25- 55, non-modification of treatment and medications for at least the past 2 months, moderate physical activity
Exclusion criteria: Use of insulin, diabetes for more than 10 years, pregnancy and lactation, patients with severe renal and hepatic dysfunction, alcohol consumption
Intervention groups
Intervention group: the group receiving ellagic acid (200mg daily) Control group: placebo group
Main outcome variables
Fasting blood sugar, 2 hours sugar, Glycosylated hemoglobin, insulin resistance, lipid profile, oxidative stress indices, inflammatory factors, expression of miR146-a, SIRT1, and Fetuin A
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141025019669N13
Registration date:2019-09-24, 1398/07/02
Registration timing:registered_while_recruiting
Last update:2019-09-24, 1398/07/02
Update count:1
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-31, 1398/06/09
Expected recruitment end date
2019-11-30, 1398/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the ellagic acid supplementation effect on glycemic status, insulin resistance, inflammatory factors, antioxidant status and expression of miR146-a in patients with type 2 diabetes: double blind randomized clinical trial
Public title
Ellagic acid supplementation effect in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with with type 2 diabetes
Willingness to work
Age 25- 55
Non-modification of treatment and medications for at least the past 2 months
Moderate physical activity
Exclusion criteria:
Insulin using
Having diabetes for more than ten years
Pregnancy and breastfeeding
Patients with severe renal and hepatic dysfunction,
Alcohol consumption
Age
From 24 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done randomly using lottery method. Each patient will receive a number or code, and then we will write the numbers on pieces of paper. We will then place the pieces of paper in a container and select the samples according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo will be placed in similar containers and encode by someone except investigator, so patients and the investigator will be blinded to medicine and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2019-07-19, 1398/04/28
Ethics committee reference number
IR.QUMS.REC.1398.079
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
2
Description
2 hours sugar
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
3
Description
Insulin resistance
Timepoint
Before the intervention and after the intervention
Method of measurement
Using the formula
4
Description
Glycosylated hemoglobin
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
5
Description
Lipid profile
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
6
Description
Total antioxidant capacity
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
7
Description
Glutathione peroxidase enzyme
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
8
Description
Superoxide dismutase enzyme
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
9
Description
Malondialdehyde
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
10
Description
Inflammatory factors
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
11
Description
Expression of miR146-a
Timepoint
Before the intervention and after the intervention
Method of measurement
Real-Time PCR
12
Description
SIRT1
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
13
Description
Fetuin A
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ellagic acid, a capsule 200 mg per daily for two months, Manufacturer: Supplement Spot
Category
Treatment - Drugs
2
Description
Control group: A daily placebo capsule containing wheat flour for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Peimani
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor for Research of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after people are unrecognizable
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no objection to the use of data provided the source of the resource.
From where data/document is obtainable
By contacting the email address of a person responsible for general inquiries
khademnut@yahoo.com
What processes are involved for a request to access data/document