Survey and Comparison of the effect of fortified yogurt enriched with fermented and non-fermented Spirulina Platensis extract on reducing oxidative stress in patients with type 2 diabetes mellitus
investigating the effect of yogurt enriched with spirulina platensis extract fermented with lactobacillus plantarium on reducing oxidative stress in patients with type 2 diabetes mellitus and comparing its results with the effect of yogurt enriched with unfermented spirulina platensis extract
Design
Clinical trial without control group - laboratory test before and after the intervention. , parallel groups, double-blind, randomized on 100 patients. The rand function of Excel software will used for randomization.
Settings and conduct
In this study, the effect of low-fat yogurt enriched with oral spirulina platensis algae on type 2 diabetic patients is investigated, and the effect of fermented and non-fermented types of spirulina used in low-fat yogurt in these patients is investigated. The location of the project in Iran is the city of Arak - diabetes clinics. 100 type 2 diabetic patients in the age group of 40 to 70 years enter the project and are randomly assigned to the first and second groups. Patients do not know the type of food powder used in low-fat yogurt.
Participants/Inclusion and exclusion criteria
Entry requirements: having type 2 diabetes for at least 2 years - age between 40 and 70 years
Exit conditions: insulin injection
Intervention groups
100 people with diabetes participate in the plan. 50 people are randomly given yogurt containing spirulina algae extract for consumption and 50 people are given yogurt containing fermented spirulina extract. The laboratory criteria are evaluated before the intervention and after the intervention.
Main outcome variables
Examination of changes in fasting blood sugar; Malon dialdehyde level changes; changes in total antioxidant capacity; Changes in the level of glutathione regeneration and changes in the level of high-sensitivity active protein C in the blood serum of type 2 diabetes patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220108053663N1
Registration date:2022-10-09, 1401/07/17
Registration timing:registered_while_recruiting
Last update:2022-10-09, 1401/07/17
Update count:0
Registration date
2022-10-09, 1401/07/17
Registrant information
Name
Ayda Ghafari Ashtiani
Name of organization / entity
Islamic Azad University, Science and Research Branch
Country
Iran (Islamic Republic of)
Phone
+98 86 3276 0036
Email address
aida_gh60@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey and Comparison of the effect of fortified yogurt enriched with fermented and non-fermented Spirulina Platensis extract on reducing oxidative stress in patients with type 2 diabetes mellitus
Public title
Investigating the effect of Spirulina platensis algae in the treatment of diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes mellitus
Exclusion criteria:
Type1 diabetes mellitus
Patients injecting insulin
Age less than 40 and more than 70 years
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a double-blind randomized clinical trial study, which was considered by the diabetes clinic affiliated to Arak University of Medical Sciences to select patients with type 2 diabetes in the age group of 40-70 years. After voluntarily choosing 100 patients to participate in the study and providing explanations about the goals of the project and after obtaining their informed consent to participate in the study, a list of participants is prepared and coded. And the codes are entered in SPSS statistical software and using simple randomization method, people are divided into two groups of 50 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention is a type of double-blind randomized clinical trial. None of the participants and examiners will know about the allocation of groups to the intervention under study. The intended intervention is similar in terms of appearance (smell, color, appearance, etc.).
Placebo
Not used
Assignment
Parallel
Other design features
In this study, spirulina algae is fermented and the effect of fermented type of algae is compared with non-fermented algae.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Science and Research Unit
Street address
Islamic Azad University, Department of Science and Research - Sattari Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2022-08-22, 1401/05/31
Ethics committee reference number
IR.IAU.SRB.REC.1401.094
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
Average changes in reduced glutathione levels in the blood serum of type 2 diabetics
Timepoint
Measurement of blood reduced glutathione levels before the intervention and 21 days after the intervention
Method of measurement
reduced glutathione blood level measurement kit
2
Description
Average changes in fasting blood sugar levels in the blood serum of type 2 diabetics
Timepoint
Measurement of fasting blood sugar before the intervention and 21 days after the intervention
Method of measurement
fasting blood sugar measurement kit
3
Description
Average changes in high reactive protein C level in blood serum of type 2 diabetic patients
Timepoint
Measurement of C protein with high reactivity in blood serum before the intervention and 21 days after the intervention
Method of measurement
C- Reactive protein measurement kit
Secondary outcomes
1
Description
malondialdehyde( MDA)
Timepoint
Malondialdehyde content is measured before and 21 days after consumption of yogurt enriched with fermented and non-fermented Spirulina Platensis.
Method of measurement
diagnostic malondialdehyde assay kit
2
Description
Ferric Reducing Ability of Plasma( FRAP)
Timepoint
Before starting consumption and 21 days after starting consumption of yogurt enriched with fermented and non-fermented spirulina platensis, the antioxidant capacity of total plasma is measured.
Method of measurement
FRAP Detection Assay Kit
Intervention groups
1
Description
Intervention group: After the patients visited the diabetes clinic for the plan, full explanations about the objectives of the study will be given to them during a one-hour training session. Then, after obtaining their informed written permission and consent to voluntarily participate in the study, people are randomly divided into two groups of 50 people, 50 type 2 diabetic patients, daily 200 grams of low-fat yogurt containing 20 grams of non-fermented spirulina algae powder. It is suggested that the patient consumes 100 grams of yogurt in two meals for 21 days. Algae powder manufacturer is Berkeh Sabz Mad Asia Company, and it is one of the factories in the country and has a health license from the Vice-Chancellor of Food and Medicine of Arak University of Medical Sciences.
Category
Treatment - Other
2
Description
Intervention group: After the patients visited the diabetes clinic for the plan, full explanations about the objectives of the study will be given to them during a one-hour training session. Then, after obtaining their informed written permission and consent to voluntarily participate in the study, people are randomly divided into two groups of 50 people, 50 type 2 diabetic patients, daily 200 grams of low-fat yogurt containing 20 grams of fermented spirulina algae powder. It is suggested that the patient consumes 100 grams of yogurt in two meals for 21 days. Algae powder manufacturer is Berkeh Sabz Mad Asia Company, and it is one of the factories in the country and has a health license from the Vice-Chancellor of Food and Medicine of Arak University of Medical Sciences.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aida Ghaffari Nutrition and Diet Therapy Center
Full name of responsible person
Aida Ghaffari
Street address
no201- Dr Neysanian dulding- Dr Neysanian Street
City
Arak
Province
Markazi
Postal code
3813754417
Phone
+98 86 3221 3474
Email
aida_gh60@yahoo.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
Sardasht Square, Arak Medical University
City
Arak
Province
Markazi
Postal code
3815937458
Phone
+98 86 3313 6055
Email
kalantari_neda@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak Medical University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anoosheh Sharifan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Food Technology and Quality Control
Street address
Science and Research branch, Islamic Azad University
City
tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
a_sharifan2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ayda Ghaffari
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
no108- Sefid Tower, Mirza Shirazi street
City
Arak
Province
Markazi
Postal code
3815937458
Phone
+98 86 3276 0036
Fax
Email
AIDA_GH60@YAHOO.COM
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ayda Ghaffari
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
no108- Sefid Tower, Mirza Shirazi street
City
Arak
Province
Markazi
Postal code
3815937458
Phone
+98 86 3276 0036
Fax
Email
AIDA_GH60@YAHOO.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
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
The individual information of the participants without the names of the people, the spss file includes the results of fasting blood sugar, malondialdehyde, glutathione regeneration and the total antioxidant level of the blood serum of the patients can be shared. Statistical tests cannot be delegated.
When the data will become available and for how long
starting in september 2023
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 required.
From where data/document is obtainable
Refer to the email below.
aida_gh60@yahoo.com
What processes are involved for a request to access data/document