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The Effect of Spirulina Platensis on fasting blood Glucose, Glycosylated Hemoglobin (HbA1c) and Lipid Profile in Type 2 diabetic Patients in Mashhad

Protocol summary

Study aim
Effect of spirulina alga on blood glucose, reducing glycosylated hemoglobin and improving lipid profiles
Design
Clinical trials with a control and intervention group (60 patients in total) will be studied in parallel, one blind and randomized Conditions.
Settings and conduct
60 patients referred to Shahid Ghodsi diabetes Center in Mashhad will be randomly assigned into two intervention and control groups. The control group, which will receive conventional anti-diabetes treatment and placebo, and the treatment group, in addition to its usual treatment, will receive Spirulina powder in two divided doses of 1 g, 12 hours apart. The study lasts for 90 days. Hb A1c is evaluated as an initial outcome immediately before intervention and at the end of the intervention. Lipid profiles (TG, HDL, LDL, Cholesterol) and fasting blood glucose levels are recorded on days 0, 30, 60 and 90. Patients, physicians and data analyst team will be blind on one side.
Participants/Inclusion and exclusion criteria
People entering the study will have type 2 diabetes, ranging in age from 30 to 60 years old, and have been treated with anti-diabetes drugs for less than 5 years. Non-arrival conditions: Not having diabete Having diabete but: Pregnancy and lactation, Patients with phenylketonuria, Patients with autoimmune diseases, Patients with kidney or liver failure Use of antioxidant supplements and vitamins (especially B groups)
Intervention groups
To evaluate the effect of spirulina algae in the both control and treatment groups, HbA1c was evaluated as an initial outcome immediately before the intervention and at the end of the intervention. Also, lipid profiles (TG, HDL, LDL, Cholesterol) and fasting blood glucose levels are recorded on days 0, 30, 60 and 90.
Main outcome variables
Measured variables to assess the effect of intervention: HbA1c, lipid profiles (TG, HDL, LDL, Cholesterol) and FBS levels in patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180418039348N1
Registration date: 2018-06-02, 1397/03/12
Registration timing: registered_while_recruiting

Last update: 2018-06-02, 1397/03/12
Update count: 0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Javad Boskabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3657 9723
Email address
boskabadij901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spirulina Platensis on fasting blood Glucose, Glycosylated Hemoglobin (HbA1c) and Lipid Profile in Type 2 diabetic Patients in Mashhad
Public title
The Effect of Spirulina Platensis on fasting blood Glucose and Lipid Profile in Type 2 diabetic Patients in Mashhad
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 Diabetes Mellitus Fasting plasma glucoseis equal to or greater than 100 to 125 mg / dl The OGTT test equal to or greater than 140 to 199 mg / dl Hb1c: 4.6 to 7.5 Less than 5 years of treatment with anti-diabetes drugs
Exclusion criteria:
Not having diabetes Pregnancy and lactation Patients with phenylketonuria 36/5000Patients with autoimmune diseases Patients with kidney or liver failure Use of antioxidant supplements and vitamins (especially B vitamin groups)
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After completing the consent form, at least 60 patients will be randomly assigned to two groups of control and intervention. The control group, which will receive conventional anti-diabetes treatment and placebo, and the treatment group, in addition to its usual treatment, will receive Spirulina concentrate powder at a dose of 2 g per day (in two divided doses of 1 g, 12 hours apart).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study, the physician and the clinical team evaluating the side effects and efficacy of the drug and the data analyst have been kept blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Knowledge and Science Town, Fakori Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2016-11-06, 1395/08/16
Ethics committee reference number
IR.MUMS.SP.1395.64

Health conditions studied

1

Description of health condition studied
The Effect of Spirulina Platensis on fasting blood Glucose, Glycosylated Hemoglobin (HbA1c) and Lipid Profile in Type 2 diabetic Patients
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
The primary outcome is the change in hemoglobin beta-glycosylated (HbA1c) levels.
Timepoint
The timing is measured at the beginning of the study and the days 30, 60, and 90 of the study.
Method of measurement
Chromatography will be used to measure HbA1c.

Secondary outcomes

1

Description
ّFasting blood Glucoseand Lipid Profile
Timepoint
The timing is measured at the beginning of the study and the days 30, 60, and 90 of the study.
Method of measurement
Blood glucose analysis and use of lipid profile kits

Intervention groups

1

Description
Intervention group: Patients enrolled in the study will be in control and intervention groups. In addition to conventional anti-diabetic treatment, the intervention group will receive Spirulina concentrate powder at a dose of 2 g / day (in two divided doses of 1 g / 12 hours and powders will be supplied in gelatin capsules of 500 mg). These patients are monitored for 90 days.
Category
Treatment - Drugs

2

Description
Control group: Patients enrolled in the study will be in control and intervention groups. The control group will receive conventional anti-diabetic treatment that has been prescribed and will receive placebo. These patients are monitored for 90 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Ghodsi Health Center
Full name of responsible person
Sousan Dolatabadi
Street address
Sanabad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3844 0077
Email
dolatabadis1@mums.ac.ir
Web page address
http://behdasht3.mums.ac.ir/index.php/43-persian-category/229-ghodsi

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah Street Mashhad Khorasan Razavi Iran, Islamic Republic of Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Phone
+98 51 3882 3255
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Taherzadeh
Position
Associated Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Province
Razavi Khorasan
Postal code
1365-91775
Phone
+98 51 3882 3255
Email
Taherzadehzh@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Taherzadeh
Position
Associated Proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Email
Taherzadehzh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Boskabadi
Position
Lack scientific grade - Pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad University of Medical Sciences, Azadi Square, Mashhad, Khorasan Razavi, Islamic Republic of Iran
City
Masshad
Province
Razavi Khorasan
Postal code
9766167367
Phone
+98 51 3657 9723
Email
boskabadij901@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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