Evaluation and comparison of malondialdehyde (MDA) level, reduced glutathione, non-enzymatic antioxidant capacity (FRAP), fasting blood sugar level (FBS) and HS-CRP level in patients receiving non-fermented spirulina platensis extract and fermented spirulina
Design
Clinical trial with control group, with parallel groups, one-way blinded , randomized on 150 patients.
Settings and conduct
In this study, the effect of oral Spirulina platensis on type 2 diabetic patients and also the effect of fermented and non-fermented spirulina in these patients will investigate. location of study will be in Iran-Arak diabetes clinics. 150 type 2 diabetic patients in the age group of 50 to 70 years will enterto study and randomly devided to tree group by block method. Patients do not know the type of food powder consumed.
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes in the age group of 50 to 70 years, whether male or female
Intervention groups
This study is a randomized clinical trial in which patients with type 2 diabetes in the age group of 50 to 70 years will be included. 150 patients are randomly divided into 3 groups by block method. The first group received fermented Spirulina Platensis (n = 50) The second group received non-fermented Spirulina Platensis (n = 50) and the third group is control group(n= 50), in the first group 4 g of fermented Spirulina Platensis twice a day for 7 days , In the second group, 4 grams of non-fermented spirulina platensis will be given twice a day for 7 days and in the third group, placebo will be given, 4 g wheat bran twice a day for 7 days
Main outcome variables
Reducing the effects of oxidative stress in patients with type 2 diabetes by consuming the Spirulina platensis.
Comparison of reducing the effects of oxidative stress in patients with type 2 diabetes with the use of fermented and unfermented Spirulina platensis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220109053671N1
Registration date:2022-02-13, 1400/11/24
Registration timing:prospective
Last update:2022-02-13, 1400/11/24
Update count:0
Registration date
2022-02-13, 1400/11/24
Registrant information
Name
Morteza Qaribi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 1041
Email address
dr.gharibi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oxidative stress biomarkers in type 2 diabetic patients consuming fermented and non-fermented spirulina platensis
Public title
Evaluation of antioxidant effect of Spirulina platensis in type 2 diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes that is at least 2 years old diabetics
Exclusion criteria:
People with type 1 diabetes
People under the age of 49 and over 70 years old
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method: in this method, from the list of diabetic patients in the clinic, diabetic patients between 50 and 70 years old who have had diabetes for at least one year are separated, then the prepared list is numbered and entered into SPSS software. In SPSS software, 3 groups are selected by simple random sampling calculations.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the sampling method, both the spirulina group and the placebo group are unaware of the supplement they are taking. The examiner also does not know which supplement each group took.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
University Complex of the Great Prophet (PBUH)-Basij Square- Sardasht
City
Arak
Province
Markazi
Postal code
6341738481
Approval date
2022-01-17, 1400/10/27
Ethics committee reference number
IR.ARAKMU.REC.1400.255
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Mean of fast blood glucose
Timepoint
Day before and eight days after starting the study
Method of measurement
Through special clinical assessment kits
2
Description
HS-CRP
Timepoint
Day before and eight day after starting the study
Method of measurement
Through special clinical assessment kits
3
Description
Malondialdehyde
Timepoint
Day before and eight days after starting the study
Method of measurement
Through special clinical assessment kits
4
Description
Reduced Glutathione
Timepoint
Day before and eight days after starting the study
Method of measurement
Through special clinical assessment kits
5
Description
Non-enzymatic antioxidant capacity
Timepoint
Day before and eight days after starting the study
Method of measurement
Through special clinical assessment kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Presenting 8 g of oral Spirulina platensis algae powder in two meals of 4 g per day to the patient for 7 days continuously
Category
Treatment - Other
2
Description
Intervention group: Presenting 8 g of Spirulina platensis algae powder fermented with Lactobacillus plantarum in two meals of 4 g / day for 7 days
Category
Treatment - Other
3
Description
Control group: Presenting 8 grams of edible wheat bran powder in two 4 gram meals per day to the patient for 7 days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Dr Faezeh Soufian
Street address
Shahid Shiroodi street
City
Arak
Province
Markazi
Postal code
3813899589
Phone
+98 86 3402 0021
Fax
+98 86 3402 0030
Email
faezesoufiyan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ali Kamali
Street address
Payambar University Complex- Basij Square - Sardasht
City
Arak
Province
Markazi
Postal code
6341738481
Phone
+98 86 3417 3520
Fax
+98 86 3147 3521
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Morteza Gharibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
University Complex of the Great Prophet (PBUH)-Basij Square- Sardasht- Arak- Iran
City
Arak
Province
Markazi
Postal code
6341738481
Phone
+98 86 3276 0036
Email
morteza.qaribi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Morteza Gharibi
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
University Complex of the Great Prophet (PBUH)-Basij Square- Sardasht- Arak- Iran
City
Arak
Province
Markazi
Postal code
3815937458
Phone
+98 86 3276 0036
Email
morteza.qaribi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Morteza Gharibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
University Complex of the Great Prophet (PBUH)-Basij Square- Sardasht- Arak- Iran
City
Arak
Province
Markazi
Postal code
3815937458
Phone
+98 86 3276 0036
Email
morteza.qaribi@gmail.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Articles extracted from the project are shared in a reputable journal. The article contains clinical trial data and will not refer to a specific person.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
No special conditions are considered
From where data/document is obtainable
Applicants should send an email to Dr. Morteza Gharibi to receive information/ morteza.qaribi@gmail.com
What processes are involved for a request to access data/document
The applicant must send an e-mail to Dr. Morteza Gharibi stating his intentions in requesting information. The sent email will be checked and answered within a week.