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
-
-
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
-
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
-
-
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
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.
-
Comments
-