Protocol summary

Study aim
Study of the effect of consumption of omelette powder (Abelmoschus esculentus) mixed with yogurt on lipid profiles, blood pressure, blood glucose and HbA1c levels in patients with type 2 diabetes
Design
A clinical trial with control and control group, with parallel groups, blind, randomized
Settings and conduct
In this double-blind study, we selected 60 outpatients with type 2 diabetes who were referred to diabetes clinics based on entry criteria, and then randomly divided into two groups of 30 adolescents. The scientific name of the okra plant will be 200 kilograms of greengroceries. After collecting and rinsing, the okra was completely dried in dry conditions for several days, and after preparing dried okra powder, it was packed in 10 grams and delivered to the milk and yogurt factory, and the factory supplied 150 grams of yogurt With a mixture of 10 grams of okra powder, it is recommended that a group of yogurt be taken with okra, and the other group only uses yogurt. Then, if you want people every week, by nurse patients divided into two groups, yogurt is mixed with yogurt and yogurt is given only.
Participants/Inclusion and exclusion criteria
Age 30 to 70 years old and from both sexes Taking oral anti diabetic medicine No pregnancy Lack of alcohol Do not take anti-hypertensive medication No smoking Not taking herbal supplement to control blood glucose Non-lactation in women Not getting kidney disease, especially diabetic nephropathy Ostrich sensitivity get pregnant Unwillingness to cooperate
Intervention groups
We will select 60 outpatient type II diabetic patients based on entry criteria and then randomly divide the blocks into two groups of 30, which will be given to a mixture of yogurt and okra, and the other will be yogurt.
Main outcome variables
Fasting blood sugar, serum LDL-C, serum HDL-C, serum TG, total cholesterol, blood pressure, weight, age, sex, activity, hemoglobin A1c

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190701044064N1
Registration date: 2019-09-14, 1398/06/23
Registration timing: retrospective

Last update: 2019-09-14, 1398/06/23
Update count: 0
Registration date
2019-09-14, 1398/06/23
Registrant information
Name
arezoo moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 2292
Email address
arezoo.m@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-04-21, 1398/02/01
Scientific title
Comparison of the Efficacy of Okra powder mixed with Yogurt and Yogurt in Controlling Fasting Blood Glucose (FBS) in Patients with Type 2 Diabetes
Public title
Okra in Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Taking Oral Anti Diabetic Medicine No Pregnancy Lack of Alcohol Do not Take Anti Hypertensive Medication No Smoking Not Taking Herbal Supplement to Control Blood Glucose Non Lactation in Women Not Getting Kidney Disease, Especially Diabetic Nephropathy
Exclusion criteria:
Okra Sensitivity Get Pregnant Unwillingness to Cooperate
Age
From 30 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In this Double-blind Study, We Selected 60 Outpatients with type 2 Diabetes who were referred to Diabetes Clinics based on entry Criteria, and then Randomly divided into two groups of 30 adolescents.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind, randomized, double-blind, clinical trial of 60 patients with type 2 diabetes who are referred to the diabetes center for a period of 8 weeks. The patient was visited by a doctor at her first visit to the treatment centers. A form of willingness to participate in the intervention is taken from the written consent form. Patients are requested to fill out a form for evaluating entry criteria.For this study 200 kilograms of okra have been purchased. After washing, drying and grinding, and then in 10 grams packages, the milk and yogurt factory will be delivered to 150 grams of yogurt, and it is recommended to patients to mix mixed yogurt After lunch or dinner, take daily oatmeal everyday. In this study, simple yogurt was used as a placebo. Patients are advised to spend their yogurt after lunch or dinner. In this study, the investigator will be unaware of the fact that the yogurt is given to the patient or the yoghurt is unaware and the nurse is only aware that the person is based on that Which group contains the drug or the placebo? Also, the analyst is also well aware.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Medical Ethics Committee
Street address
Isfahan University of Medical Sciences. Isfahan Nutrition and Food Sciences Faculty
City
Isfahan
Province
Isfehan
Postal code
7718716715
Approval date
2018-01-25, 1396/11/05
Ethics committee reference number
IR.MUI.REC.1396.121

Health conditions studied

1

Description of health condition studied
Diabet
ICD-10 code
I00-I99
ICD-10 code description
Diseases of the circulatory system

Primary outcomes

1

Description
Fasting blood glucose
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical method

2

Description
Serum LDL-C
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical method

3

Description
HDL-C Serum
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical method

4

Description
TG Serum
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical method

5

Description
Total cholesterol
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical method

6

Description
Hemoglobin A1c
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical method

Secondary outcomes

1

Description
blood pressure
Timepoint
The beginning and the end of the study
Method of measurement
Blood pressure monitor

2

Description
Weight
Timepoint
The beginning and the end of the study
Method of measurement
digital Balance

3

Description
Age
Timepoint
Beginning of study
Method of measurement
questionnaire

4

Description
Sex
Timepoint
Beginning of study
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Okra plant will be supplied with a scientific name of 200 kilograms of greens. After collecting and rinsing, the okra was completely dried in dry conditions for several days, and after preparing dried okra powder, it was packed in 10 grams and delivered to the milk and yogurt factory, and the factory supplied 150 grams of yogurt Mix 10 grams of okra powder and mix the yogurt with okra after your main meal, lunch or dinner.
Category
Treatment - Other

2

Description
Control group: This group is recommended to eat 150g yogurt after their main meal, lunch or dinner
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Arezoo Moradi
Street address
Ali Ibn Abi Talib Hospital, Ali Ibn Abi Talib Square
City
Rafsanjan
Province
Kerman
Postal code
7713166116
Phone
+98 34 3428 9787
Email
moradi8028@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ms. Fatemeh Samadanian
Street address
School of Nutrition and Nutrition, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
7718716715
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
moradi8028@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Seyyed Morteza Safavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biochemistry
Street address
Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7713166116
Phone
+98 317923164
Fax
+98 31 3792 2709
Email
moradi8028@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arezoo Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 23, Imam Ali Street 9, Thousand Unit Settlement
City
Rafsanjan
Province
Kerman
Postal code
7713166116
Phone
+98 34 3429 2292
Email
moradi8028@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arezoo Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 23, Imam Ali Street 9,Thousand Unit Settlement
City
Rafsanjan
Province
Kerman
Postal code
7713166116
Phone
+98 34 3429 2292
Email
moradi8028@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Only part of the data, such as the key outcome information or the like, can share.
When the data will become available and for how long
Start period of 3 months after publication of the article
To whom data/document is available
Researchers at academic and academic institutions
Under which criteria data/document could be used
Research
From where data/document is obtainable
Arezoo moradi Contact number 09140613368, Address: Kerman- Rafsanjan Town of Thousand Units of Imam Ali Street Postal Code 7713166116
What processes are involved for a request to access data/document
Academic Requests
Comments
Loading...