The effects of okra (Abelmoschus esculentus) fruit dried extract on several genes expression, serum metabolic, oxidative stress, and autophagy- related parameters, anthropometric indices, appetite, and kidney function in diabetic nephropathic patients
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
60
50
6050
30
25
3025
empty
55
55
No
No
empty
2020-06-21, 1399/04/01
2020-06-21 00:00:00
empty
2021-01-04, 1399/10/15
2021-01-04 00:00:00
empty
2021-09-23, 1400/07/01
2021-09-23 00:00:00
The sample size was estimated based on blood glucose, using mean and standard deviation obtained from yet unpublished data of Ghaffari et al. with 95% confidence (α = 0.05) and 80% power (β = 20%). About 23 patients were estimated to be in each group; however,30 patients would be recruited in each group, considering the probable loss. Each group will consist of patients with diabetic nephropathy whom will randomly receive either dried extract of Okra or placebo (carboxymethyl cellulose).
The sample size was estimated based on blood glucose, using mean and standard deviation obtained from yet unpublished data of Ghaffari et al. with 95% confidence (α = 0.05) and 80% power (β = 20%). About 23 patients were estimated to be in each group; however,25 patients would be recruited in each group, considering the probable loss. Each group will consist of patients with diabetic nephropathy whom will randomly receive either dried extract of Okra or placebo (carboxymethyl cellulose).
The sample size was estimated based on blood glucose, using mean and standard deviation obtained from yet unpublished data of Ghaffari et al. with 95% confidence (α = 0.05) and 80% power (β = 20%). About 23 patients were estimated to be in each group; however,30however,25 patients would be recruited in each group, considering the probable loss. Each group will consist of patients with diabetic nephropathy whom will randomly receive either dried extract of Okra or placebo (carboxymethyl cellulose).
حجم نمونه بر اساس متغیر گلوکز خون و با استناد به میانگین و انحراف معیارهاي بدست آمده از مطالعه غفاری و همکاران که در حال چاپ می باشد و با ضریب اطمینان 95 درصد (0/05= α) و توان 80 درصد (20%= β) در هر گروه 23 بیمار برآورد گردید که با احتمال ریزش نمونه ها در هر یک از گروهها 30 بیمار گرفته خواهد شد. هر یک از گروههای مورد مطالعه شامل بیماران مبتلا به نفروپاتی دیابتی خواهند بود که به صورت تصادفی مکمل عصاره خشک بامیه یا دارونما متشکل از کربوکسی متیل سلولز دریافت خواهندنمود.
حجم نمونه بر اساس متغیر گلوکز خون و با استناد به میانگین و انحراف معیارهاي بدست آمده از مطالعه غفاری و همکاران که در حال چاپ می باشد و با ضریب اطمینان 95 درصد (0/05= α) و توان 80 درصد (20%= β) در هر گروه 23 بیمار برآورد گردید که با احتمال ریزش نمونه ها در هر یک از گروهها 25بیمار گرفته خواهد شد. هر یک از گروههای مورد مطالعه شامل بیماران مبتلا به نفروپاتی دیابتی خواهند بود که به صورت تصادفی مکمل عصاره خشک بامیه یا دارونما متشکل از کربوکسی متیل سلولز دریافت خواهندنمود.
حجم نمونه بر اساس متغیر گلوکز خون و با استناد به میانگین و انحراف معیارهاي بدست آمده از مطالعه غفاری و همکاران که در حال چاپ می باشد و با ضریب اطمینان 95 درصد (0/05= α) و توان 80 درصد (20%= β) در هر گروه 23 بیمار برآورد گردید که با احتمال ریزش نمونه ها در هر یک از گروهها 30 بیمار25بیمار گرفته خواهد شد. هر یک از گروههای مورد مطالعه شامل بیماران مبتلا به نفروپاتی دیابتی خواهند بود که به صورت تصادفی مکمل عصاره خشک بامیه یا دارونما متشکل از کربوکسی متیل سلولز دریافت خواهندنمود.
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Maryam Saghafi Asl
Full name of responsible person - Persian: دکتر مریم ثقفی اصل
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Tabriz
Street address - Persian: تبریز ،خیابان خطارنیشابوری،دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 516665931
Phone: +98 33357581
Mobile: +98 914 418 2195
Fax:
Email: Saghafiaslm@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Maryam Saghafi Asl
Full name of responsible person - Persian: دکتر مریم ثقفی اصل
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Tabriz
Street address - Persian: تبریز ،خیابان خطارنیشابوری،دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 516665931
Phone: +98 33357581
Mobile: +98 914 418 2195
Fax:
Email: Saghafiaslm@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Maryam Saghafi Asl Full name of responsible person - Persian: دکتر مریم ثقفی اصل Position - English: AssistantAssociate Professor Position - Persian: استادیاردانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Tabriz Street address - Persian: تبریز ،خیابان خطارنیشابوری،دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 516665931 Phone: +98 33357581 Mobile: +98 914 418 2195 Fax: Email: Saghafiaslm@gmail.com Web page address:
Protocol summary
Study aim
To determine the effects of okra (Abelmoschus esculentus) fruit dried extract on several genes expression, serum metabolic, oxidative stress, and autophagy- related parameters, anthropometric indices, appetite, and kidney function in diabetic nephropathic patients
Design
A randomized, controlled, triple-blind, clinical trial with 60 patients
Settings and conduct
Participants in this study will be selected from patients with diabetic nephropathy referred to Tabriz Imam Reza Hospital, after being confirmed by a specialist. Patients in this study will be randomly divided into placebo and supplement groups. All stages of the study as well as the interventions and follow-ups will be done in the Faculty of Nutrition,Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 40 to 70 years, BMI≥25 kg/m2 and BMI<38 kg/m2,
Excretion of protein greater than 0.3g in 24-hour urine for more than 3 months، Willingness to participate in the study.
B) Exclusion criteria: Weekly consumption of okra over the past three months, Pregnancy and lactation,Other Kidney Diseases, Liver Disease, Thyroid disorders and Inflammatory Diseases, Cancer, NSAIDS consumption and so on, energy intake less than 800 or more than 4200 kcal per day based on a three-day food record questionnaire, Following unusual weight loss regimens (like water treatment, single food eating, Canadian diet, etc.) 3 months before the enrollment, People taking warfarin or other anti-coagulants، Cardiovascular Disease (Stages 2 and 3), Uncontrolled diabetes (HbA1c>8).
Intervention groups
Supplement group (Okra recipient), placebo group (Carboxymethyl cellulose recipient)
Main outcome variables
metabolic, antioxidant, kidney, inflammatory, and autophagy-related parameters
General information
Reason for update
to add some new parameters to the project
Acronym
IRCT registration information
IRCT registration number:IRCT20110530006652N3
Registration date:2020-04-16, 1399/01/28
Registration timing:prospective
Last update:2022-03-04, 1400/12/13
Update count:2
Registration date
2020-04-16, 1399/01/28
Registrant information
Name
Maryam Saghafi asl
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7581
Email address
saghafiaslm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2021-01-04, 1399/10/15
Trial completion date
2021-09-23, 1400/07/01
Scientific title
The effects of okra (Abelmoschus esculentus) fruit dried extract on several genes expression, serum metabolic, oxidative stress, and autophagy- related parameters, anthropometric indices, appetite, and kidney function in diabetic nephropathic patients
Public title
The effects of okra (Abelmoschus esculentus) fruit dried extract on kidney function in diabetic nephropathic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI ≥25 kg / m2 and BMI <38kg / m2
Age: 40 to 70 years
Excretion of protein greater than 0.3 g in 24-hour urine for more than 3 months
Willingness to participate in the study
Exclusion criteria:
Weekly consumption of okra over the past three months
Pregnancy and lactation
Other Kidney Diseases, Liver Disease, Thyroid disorders and Inflammatory Diseases, Cancer, NSAIDS consumption and so on.
Energy intake less than 800 or more than 4,200 kcal per day based on a three-day feed record questionnaire
Following unusual weight-loss regimens 3 months before the enrollment (like water treatment, single food eating, Canadian diet, ...)
People taking warfarin or other anti-coagulants
Cardiovascular Disease (Stages 2 and 3)
Uncontrolled diabetes mellitus (HbA1c>8)
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
25
The sample size was estimated based on blood glucose, using mean and standard deviation obtained from yet unpublished data of Ghaffari et al. with 95% confidence (α = 0.05) and 80% power (β = 20%). About 23 patients were estimated to be in each group; however,25 patients would be recruited in each group, considering the probable loss. Each group will consist of patients with diabetic nephropathy whom will randomly receive either dried extract of Okra or placebo (carboxymethyl cellulose).
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, the eligibility criteria including BMI, age, and gender will be matched by blocking method. Sixty subjects with diabetic nephropathy will be randomly assigned into either intervention group (okra recipient) or control group (carboxymethyl cellulose recipient), using RAS software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After randomization, the dried extract of okra will be allocated into the supplement group and carboxymethyl cellulose will be given to the placebo group as a capsule. The capsules will be filled without the involvement of the researchers and will be numbered as 1 and 2 codes. The nutrition expert will introduce the capsules with either code 1 or code 2. Until the release of the study results, neither the patients nor the researchers or doctors and statistician will not be informed of the allocated codes. The numbers will be decoded at the study end-point. Therefore, the study will be triple-blinded.
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
Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.TBZMED.REC.1398.806
Health conditions studied
1
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
E08.21
ICD-10 code description
diabetic nephropathy
Primary outcomes
1
Description
fasting blood glucose
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
enzymatic colorimetric
2
Description
HBA1c
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
chromatography
3
Description
serum insulin
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
ELISA kit
4
Description
homeostatic model assessment of insulin resistance
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
calculating with formula
5
Description
LDL-C
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
calculating with formula
6
Description
HDL-C
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
7
Description
total cholesterol
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
8
Description
triglyceride
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
9
Description
serum Albumin
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
10
Description
serum creatinine
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
11
Description
Blood urea nitrogen
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
12
Description
Urine Total Protein
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
13
Description
urine creatinine
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
14
Description
serum malondialdehyde
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
15
Description
serum glitathione peroxidase
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
16
Description
advanced glycation end products
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
17
Description
Soluble receptor for advanced glycation end products
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
laboratory kit
18
Description
serum nitric oxide
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
ELISA
19
Description
hs-CRP
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
ELISA
20
Description
gene expression of interleukin-1beta
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
21
Description
gene expression of glucagon like peptide
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
22
Description
serum dipeptidyl peptidase-4
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
ELISA
23
Description
gene expression of receptor advanced glycation end products
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
24
Description
gene expression of ICAM
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
25
Description
Peroxisome proliferator–activated receptor-γ
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
26
Description
Peroxisome proliferator–activated receptor-α
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
27
Description
gene expression of NF-E2-related factor 2 (NRF-2)
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
28
Description
gene expression of Pentraxin-3
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
29
Description
gene expression of Transforming growth factor beta
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
30
Description
serum level of mTOR
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Elisa
31
Description
serum level of SIRT-1
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Elisa
32
Description
serum level of Beclin-1
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Elisa
33
Description
gene expression of Autophagy Related gene 5
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
34
Description
gene expression of LC-3
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
35
Description
gene expression of Unc-51 Like Autophagy Activating Kinase 1
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
36
Description
gene expression of Beclin-1
Timepoint
at baseline and 10 weeks after intervention
Method of measurement
Real time - PCR
Secondary outcomes
1
Description
weight
Timepoint
At baseline and three months after
Method of measurement
Digital Scales
2
Description
Waist
Timepoint
At baseline and three months after
Method of measurement
Non-elastic meter
3
Description
blood pressure
Timepoint
At baseline and three months after
Method of measurement
Blood pressure Monitor
4
Description
body fat percent
Timepoint
At baseline and three months after
Method of measurement
body composition devise
5
Description
lean body mass percent
Timepoint
At baseline and three months after
Method of measurement
body composition devise
6
Description
appetite
Timepoint
At baseline and three months after
Method of measurement
questionnaire
Intervention groups
1
Description
Control group: In this study, patients in the placebo group will receive one capsule containing 125 mg carboxymethyl cellulose for 10 weeks. Diet evaluation will be performed using a 24-hour three-day food record questionnaire (including two mid-week days and one weekend day) at baseline and at the end of the tenth week. Patients will be instructed to refrain from any change in diet, physical activity, type or dosage of their medications during the study. Otherwise, they will be excluded from the study. Patients will be followed up every two weeks by phone call so as to control the use of the placebo and prevent any drop-out . Patients will also be asked to bring the bottle of remaining capsules with them at the second visit. If a patient consumes less than 90% of the capsules, he/ she will be excluded from the study.
Category
Placebo
2
Description
Intervention group: In this study, patients in the intervention group will receive one capsule containing 125 mg dried okra extract for 10 weeks. Diet evaluation will be performed using a 24-hour three-day food record questionnaire (including two mid-week days and one weekend day) at baseline and at the end of the tenth week. Patients will be instructed to refrain from any change in diet, physical activity, type or dosage of their medications during the study. Otherwise, they will be excluded from the study. Patients will be followed up every two weeks by phone call so as to control the use of the supplements and prevent any drop-out. Patients will also be asked to bring the bottle of remaining capsules with them at the second visit. If a patient consumes less than 90% of the capsules, he/ she will be excluded from the study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Vahideh Sadra
Street address
Golgasht, Next to Tabriz University, Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3332 8832
Email
sadra.vahideh@gmail.com
2
Recruitment center
Name of recruitment center
Tabriz Sheikhoraees clinic
Full name of responsible person
Dr. Vahideh Sadra
Street address
Azadi street, Sheikhoraees clinic
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 6215
Email
sadra.vahideh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Research Center, Tabriz University of medical Sciences, Tabriz, Iran
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabouri Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
2
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiee
Street address
Research Vice-chancellor, Tabriz University of Medical Sciences, University street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1336 7499
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
omid nikpayam
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Nishabouri Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 33357581
Email
nikpayamomid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Saghafi Asl
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516665931
Phone
+98 33357581
Email
Saghafiaslm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rafat Bahreini
Position
Msc student in Nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabouri Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
516665931
Phone
+98 33357581
Email
nzi72.com@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
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
Title and more details about the data/document
Publish results
When the data will become available and for how long
After finishing and publishing the project article
To whom data/document is available
University researchers
Under which criteria data/document could be used
With permission from Project Researcher and Project Supporting Organization - Nutrition Research Center and Research Deputy
From where data/document is obtainable
Dr Maryam Saghafi Asl-Tabriz University of Medical Sciences, School of Nutrition and Nutrition, Email: Saghafiaslm@gmail.com
What processes are involved for a request to access data/document
The recipient can send an application to the study subject via email.