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The effect of ellagic acid supplementation on glycemic indices, lipid profile, anthropometric, inflammatory and oxidative indices, dietary intake and serum levels of pentosidine, adiponectin and resistin in patients with types 2: a double-blind, randomized controlled clinical trial

Protocol summary

Study aim
Determining the effect of supplementing with ellagic acid on serum levels of adiponectin, resistin, some inflammatory, oxidative indices and metabolic parameters in patients with type 2 diabetes
Design
Clinical trial with control group, with parallel groups, double-blind, randomized on 60 patients. ras software was used for randomization.
Settings and conduct
Sampling in this study will be from patients referred to Asad Abadi Hospital in Tabriz. During the intervention period, researchers and patients will not be aware the type of supplement received. The intervention period will be for 60 days and all parameters will be evaluated at the beginning and end of the study. During the intervention period, all patients will be followed up and the participants will be asked to visit each month to receive the capsules.
Participants/Inclusion and exclusion criteria
The inclusion criteria of the study include people with type 2 diabetes of both genders (patients who have been diagnosed with type 2 diabetes for at least 1 year) who are willing to participate in the project and are in the age range of 30-60 years, and with the use of oral medicine, their blood sugar is optimally controlled. The exclusion criteria include people treated with insulin, corticosteroids, non-steroidal anti-inflammatory drugs, and blood lipid-lowering drugs, as well as suffering from diseases such as cardiovascular diseases, polycystic ovary syndrome, kidney disease, hypothyroidism, and hyperthyroidism.
Intervention groups
The selected people were randomly assigned into two groups receiving the supplement (one capsule containing 250 mg of ellagic acid daily) and the placebo group (one capsule containing 250 mg of microcrystalline cellulose daily).
Main outcome variables
Inflammatory; oxidative stress; metabolic; Anthropometry indicators

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121028011288N18
Registration date: 2022-10-26, 1401/08/04
Registration timing: registered_while_recruiting

Last update: 2022-10-26, 1401/08/04
Update count: 0
Registration date
2022-10-26, 1401/08/04
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-21, 1401/07/29
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ellagic acid supplementation on glycemic indices, lipid profile, anthropometric, inflammatory and oxidative indices, dietary intake and serum levels of pentosidine, adiponectin and resistin in patients with types 2: a double-blind, randomized controlled clinical trial
Public title
The effect of Ellagic acid supplementation in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with type 2 diabetes Using blood sugar lowering medicine Age range of 30-60 years BMI in the range of 25-35 1 to 15 years duration of type 2 diabetes Tendecy of corporation
Exclusion criteria:
Use of corticosteroids, steroidal and non-steroidal anti-inflammatory drugs Prescribing insulin Suffering from chronic diseases such as heart failure, kidney, liver and thyroid disorders
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used observing equal number 6-number blocks (including n=3 for intervention group and n=3 for placebo group). Random allocation software (RAS) will be used for generating sequential numbers. For blinding, concealment allocation method will be implemented using sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators as well as the patients will be blinded to the type of supplements received by 2 groups. The person responsible for preparing the supplements boxes ( who is completely unrelated to the study) will be asked to assign a 3 digit code to each of the capsules ( supplement or placebo ) and keep the codes for himself until the end of the study and data analyses.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Golghasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
IR.TBZMED.REC.1401.445

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
Serum level of pentosidine
Timepoint
At the beginning of the study and 60 days later
Method of measurement
ELISA kit

2

Description
Serum level of adiponectin
Timepoint
At the beginning of the study and 60 days later
Method of measurement
ELISA kit

3

Description
Serum level of resistine
Timepoint
At the beginning of the study and 60 days later
Method of measurement
ELISA kit

4

Description
fasting blood sugar
Timepoint
The beginning of the study and 60 days later
Method of measurement
Enzymatic kit

5

Description
total cholesterol
Timepoint
The beginning of the study and 60 days later
Method of measurement
Enzymatic kit

6

Description
Serum triglyceride
Timepoint
The beginning of the study and 60 days later
Method of measurement
Enzymatic kit

7

Description
HDL serum level
Timepoint
The beginning of the study and 60 days later
Method of measurement
Enzymatic kit

8

Description
LDL serum level
Timepoint
The beginning of the study and 60 days later
Method of measurement
Farid Wald's formula

9

Description
Serum insulin level
Timepoint
The beginning of the study and 60 days later
Method of measurement
ELISA kit

10

Description
Hemoglobin A1c
Timepoint
The beginning of the study and 60 days later
Method of measurement
ELISA kit

11

Description
Weight
Timepoint
The beginning of the study and 60 days later
Method of measurement
Digital scale

12

Description
height
Timepoint
The beginning of the study and 60 days later
Method of measurement
Tape measure

Secondary outcomes

1

Description
Energy intake level
Timepoint
At the beginning of the study and 60 days later
Method of measurement
3-day Food Record Questionnaire

2

Description
Macronutrients intake level
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
3-day Food Record Questionnaire

Intervention groups

1

Description
Intervention group: Patients in this group will receive 1capsules of 250 milligrams of ellagic acid (product by Exir Gostar Espadana Co. and made in The Iran) for 8 consecutive weeks a day.
Category
Treatment - Other

2

Description
Control group: Control group: Patients in this group will receive microcrystalline cellulose capsules( product by Exir Gostar Espadana Co. and made in The Iran), once a day and for 8 consecutive weeks which will be same in terms of shapem size and color with those used for the intervention group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Association of East Azarbaijan Province
Full name of responsible person
Dr. Mohammad Alizadeh
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
mdalizadeh@tbzmed.ac.ir
Web page address
http://nutr.tbzmed.ac.ir/?PageID=128&ID=37&BasesID=140

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Shahabi
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
mdalizadeh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ayda Najmi
Position
Master's student in clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz university of medical sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
0098 41 4793065
Fax
Email
aydanjmy6@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz university of medical sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 914 189 4102
Email
mdalizadeh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ayda Najmi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz university of medical sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3479 3065
Email
aydanjmy6@gmail.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
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
Title and more details about the data/document
Demographic and primary outcomes data of participants
When the data will become available and for how long
Accessibility to data is possible 6 months after publication.
To whom data/document is available
Researchers who are working in academic institutes
Under which criteria data/document could be used
Only observation of documents is allowed; Analysis and use of data is not possible.
From where data/document is obtainable
mdalizadeh@tbzmed.ac.ir,09141894102 2 aydanjmy6@gmail.com,09144325240
What processes are involved for a request to access data/document
The applicant can send her request to the person in charge of the study through email, and the documents will be sent to the applicant in the shortest possible time.
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