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The effects of rutin flavonoid supplement on glycemic status, lipid profile, plasma atherogenic index, brain derived neurotropic factor (BDNF), some serum inflammatory biomarkers and oxidative stress in patients with type 2 diabetes mellitus

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History
# Registration date Revision Id
3 2021-08-20, 1400/05/29 194626
2 2021-05-07, 1400/02/17 182325
1 2020-12-30, 1399/10/10 165402
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  • General information

    2021-07-23, 1400/05/01
    2021-09-23, 1400/07/01
    empty
    Hi Due to the prevalence of Covid 19 disease and the lack of sampling, I want to change the recruitment end date to September 23, 2021. Thanks
    empty
    با سلام به علت شیوع بیماری کووید ۱۹ و عدم انجام نمونه گیری، خواستار تغییر تاریخ اتمام بیمارگیری به 1 مهر 1400 میباشم. باتشکر

  • Recruitment centers

    #1
    Name of recruitment center - English: Endocrinology clinic of Golestan hospital
    Name of recruitment center - Persian: کلینیک غدد بیمارستان گلستان
    Full name of responsible person - English: احمد زارع جاوید
    Full name of responsible person - Persian: Ahmad Zare Javid
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
    Street address - Persian: ایران، خوزستان، اهواز، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6163764754
    Phone: +98 74 3333 1257
    Fax:
    Email: ahmaddjavid@gmail.com
    Web page address:
    Name of recruitment center - English: Endocrinology clinic of Golestan hospital
    Name of recruitment center - Persian: کلینیک غدد بیمارستان گلستان
    Full name of responsible person - English: Ahmad Zare Javid
    Full name of responsible person - Persian: احمد زارع جاوید
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
    Street address - Persian: ایران، خوزستان، اهواز، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6163764754
    Phone: +98 74 3333 1257
    Fax:
    Email: ahmaddjavid@gmail.com
    Web page address:

  • Sharing plan

    yes
    undecided
    This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists and researchers.
    This clinical trial will be an research article and its results report and statistical analysis will be published to be used by therapists and researchers.
    این کارآزمایی بالینی به صورت مقاله تحقیقی در خواهد آمد و پروتکل، گزارش نتایج و آنالیز آماری آن منتشر می شود تا مورد استفاده درمانگران و محققان قرار بگیرد
    این کارآزمایی بالینی به صورت مقاله تحقیقی در خواهد آمد، و گزارش نتایج و آنالیز آماری آن منتشر می شود تا مورد استفاده درمانگران و محققان قرار بگیرد

Protocol summary

Study aim
Determination of the effects of rutin flavonoid supplement on glycemic status, lipid profile, plasma atherogenic index, brain derived neurotropic factor (BDNF), some serum inflammatory biomarkers and oxidative stress in patients with type 2 diabetes mellitus
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients. For randomization, block design is used.
Settings and conduct
Referred to the endocrine clinic of Golestan Hospital of Ahvaz in 2020, selection of 50 patients based on inclusion and exclusion criteria, randomization into intervention and control groups. Blinding of patients and researchers, coding by a third party who does not know the details.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, age between 20 to 60 years old in both sexes, over at least 2 years from time of diagnosis of diabetes, body mass index (BMI) less than 35, glycosylated hemoglobin (HbA1c) between 6.5 to 11% Non-inclusion criteria: Kidney failure, taking insulin, thyroid disease, anemia, pregnancy, lactation, smokers, use of compounds that interfere with the effects of the supplement, following of special diets other than the diet specific to diabetic patients, change of diet or decide to lose weight
Intervention groups
The intervention group: one rutin tablet of 1g/day (made by Solgar company, USA, containing 500 mg of pure rutin and 500 mg dicalcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, stearic magnesium, silica, glycerin) for 90 days. The control group: one placebo tablet of 1g/day (compounds similar to supplement except for rutin) for 90 days.
Main outcome variables
Fasting blood glucose, HbA1C, insulin resistance and insulin sensitivity indices, lipid profile, plasma atherogenic index and serum levels of IL-6, TAC, MDA, BDNF and Insulin

General information

Reason for update
Hi Due to the prevalence of Covid 19 disease and the lack of sampling, I want to change the recruitment end date to September 23, 2021. Thanks
Acronym
IRCT registration information
IRCT registration number: IRCT20151128025274N5
Registration date: 2020-12-30, 1399/10/10
Registration timing: prospective

Last update: 2021-05-12, 1400/02/22
Update count: 2
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Ahmad Zare Javid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8319
Email address
zarejavid-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of rutin flavonoid supplement on glycemic status, lipid profile, plasma atherogenic index, brain derived neurotropic factor (BDNF), some serum inflammatory biomarkers and oxidative stress in patients with type 2 diabetes mellitus
Public title
The effects of rutin flavonoid on type 2 diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study People between 20 to 60 years old in both sexes Over at least 2 years from time of diagnosis of type 2 diabetes mellitus Body mass index (BMI) less than 35 (BMI ≤ 35) Glycosylated hemoglobin (HbA1c) between 6.5 to 11%
Exclusion criteria:
Reluctance of patients to participate in the study Developing complications from diabetes such as kidney failure Diabetic patients taking insulin Thyroid disease Anemia Pregnancy, lactation Traveling more than 2 weeks Smokers Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets other than the diet specific to diabetic patients Change of diet or decide to lose weight
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Based on inclusion criteria, 50 patients will randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis and using packed envelopes is used for randomization. In fact, according to pattern and using two codes of A and B 6 groups with 4 blocks are selected. This work is repeated in 2 steps. At the end, two A and B codes are assigned to the 2 last patients and the randomization is completed (50 patients). (step1; AABB, BBAA, ABAB, BABA, ABBA, BABA, step2; AABB, BBAA, ABAB, BABA, ABBA, BABA and AB).
Blinding (investigator's opinion)
Double blinded
Blinding description
The researchers and patients will not informed of the contents of the packets. A third person of health care does the coding. This person will not aware of the details of the research trial.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-12-26, 1399/10/06
Ethics committee reference number
IR.AJUMS.REC.1399.758

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

Secondary outcomes

1

Description
Insulin
Timepoint
Before and after the intervention
Method of measurement
ELISA

2

Description
HbA1C
Timepoint
Before and after the intervention
Method of measurement
By HPLC method and with Ds5 device

3

Description
HOMA -IR
Timepoint
Before and after the intervention
Method of measurement
[FPG (mmol / l x FPI (FIU/ml)] / 22.5

4

Description
QUICKi
Timepoint
Before and after the intervention
Method of measurement
1 / [log (I0) + log (G0)] ISQUICKi

5

Description
Plasma atherogenic index
Timepoint
Before and after the intervention
Method of measurement
log TG/HDL

6

Description
HDL-c
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

7

Description
Triglyceride
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

8

Description
LDL.C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

9

Description
Total cholestrol
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

10

Description
IL-6
Timepoint
Before and after the intervention
Method of measurement
ELISA

11

Description
TAC
Timepoint
Before and after the intervention
Method of measurement
ELISA

12

Description
MDA
Timepoint
Before and after the intervention
Method of measurement
ELISA

13

Description
BDNF
Timepoint
Before and after the intervention
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days.
Category
Treatment - Other

2

Description
Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology clinic of Golestan hospital
Full name of responsible person
Ahmad Zare Javid
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
6163764754
Phone
+98 74 3333 1257
Email
ahmaddjavid@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hadi Bazyar
Position
PhD Candidate of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7853167465
Phone
+98 61 3333 0747
Email
hadibazyar2015@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Zare Javid
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6163764754
Phone
+98 74 3333 1257
Email
ahmaddjavid@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadi Bazyar
Position
PhD Candidate of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7853167465
Phone
+98 61 3333 0747
Email
hadibazyar2015@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The person's information will be confidential and the results will be as collective statistics
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This clinical trial will be an research article and its results report and statistical analysis will be published to be used by therapists and researchers.
When the data will become available and for how long
If the journal has requested access to the data at any time, the data will be provided.
To whom data/document is available
Journal editors and Reviewers
Under which criteria data/document could be used
Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable
Project manager
What processes are involved for a request to access data/document
It should be send email to project manager and after reviewing the reason for requesting the data, they will be send
Comments
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