Effects of food containing spirulina algae consumption on blood pressure, antropometric parameters, serum lipid profile and inflammation and oxidative stress indices on patients with hypertension
Determining effects of consumption of food containing spirulina algae on blood pressure, antropometric parameters, serum lipid profile and inflammation and oxidative stress indices on patients with hypertension
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 48 patients. Randomization based on the method of reversible blocks
Settings and conduct
Place of the study in Fars province, Shiraz city
Participants/Inclusion and exclusion criteria
Inclusion criteria included: Adults aged 24 to 65 years with 130 mmHg or more for Systolic blood pressure and 80 mmHg or more for Diastolic blood pressure were included
Exclusion criteria included: Any history of cardiovascular, hepatic, renal, inflammatory bowel disease, diabetes, and thyroid disorders.
Intervention groups
First group: Individuals receiving the product containing Spirulina
Second group (Control group): Individuals receiving the product without Spirulina
Main outcome variables
Blood pressure;
Antropometric parameters;
Serum lipid profile;
Serum level of hs-CRP;
Serum level of MDA.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200404046940N1
Registration date:2020-06-07, 1399/03/18
Registration timing:retrospective
Last update:2020-06-07, 1399/03/18
Update count:0
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Zohreh Ghaem Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 8693
Email address
zohreh.ghaemfar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
2020-01-16, 1398/10/26
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-18, 1398/12/28
Scientific title
Effects of food containing spirulina algae consumption on blood pressure, antropometric parameters, serum lipid profile and inflammation and oxidative stress indices on patients with hypertension
Public title
Effects of Spirulina consumption on patients with hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic blood pressure 130 mm Hg or more
Diastolic blood pressure 80 mm Hg or more
Both of the above
Between the age of 24 and 65 years
Exclusion criteria:
Suffering from cardiovascular, liver, kidney, inflammatory bowel disease, diabetes and thyroid disorders
History of cardiac surgery
Weight loss of more than 5% in the last 3 months
Participate in other studies in the last 6 months
Use any supplements or diets
Pregnancy and lactation
History of inflammation in the past two weeks (including infection, fracture, etc.)
Age
From 24 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on the method of reversible blocks
In this scheme, randomization based on the method of reversible blocks is carried out In the way that 4 blocks of 12 people will be created. These blocks are then randomly placed in two rows, male and female. Through classifying blocks by the gender, at the end of sampling we will have an equal number of male and female participants in both groups (A and B), thereby modifying the effect of gender distortion.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the first step is to allocate a specific pilot that will be used to produce products containing Spirulina and without Spirulina in a factory and will be monitored by the project scientific consultant (food industry specialist) and the researcher to ensure optimal production conditions. After that, the factory is asked to produce a sufficient number of products in the same packaging and different labels A or B. Consultant of the project and production manager are the only people who are aware of the type of packaged products. As a result, the researcher and participants will be blinded. The products are delivered from the factory after production and are given to the patients immediately. In order to concealment, all code predicted by random allocation software is placed in pockets respectively. Pockets related to a women's accidental block are placed in the first box and pockets related to a men's accidental block are placed in the second box. The lids of the boxes are designed so that only the top pocket can be removed each time. The first pocket taken from the women's box will be assigned to the first female client, who will determine which group (A or B) this person will be after opening.
The same goes for men. By doing so, the researcher cannot predict which group the next clients will fall into and the interviewer's bias will be curbed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Sciences Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.SUMS.REC.1398.1193
Health conditions studied
1
Description of health condition studied
Primary Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
Measurement of blood pressure before and 60 days after the intervention
Method of measurement
Digital Arm Sphygmomanometer
2
Description
Serum lipid profile
Timepoint
Before and 60 days after the intervention
Method of measurement
By the means of Pars Azmoon Company kit and auto analyzer BT 1500
3
Description
hs-CRP (high-sensitivity C-reactive protein)
Timepoint
Before and 60 days after the intervention
Method of measurement
By Enzyme-linked immunosorbent assay (ELISA) kit
4
Description
Malondialdehyde
Timepoint
Before and 60 days after the intervention
Method of measurement
Thiobarbituric acid method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group receiving the food product containing spirulina algae would use the product containing 2 grams of Spirulina per day up to 2 months. The products were produced in Tiondasht Keshto Sanaat company
Category
Treatment - Devices
2
Description
Control group: The group receiving the food without Spirulina algae
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Professor Kojuri clinic
Full name of responsible person
Mohammad Hosein Rahmani
Street address
Niayesh Blvd,Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7189793167
Phone
+98 71 3654 0068
Email
info@kojuriclinic.com
Web page address
http://kojuriclinic.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2884
Fax
+98 71 3235 6996
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Ghaem Far
Position
Student of master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Unit 10, Floor 4, Pakdaman Bldg, 17th Alley, Felestin St, Khajeh Ata Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916785418
Phone
+98 76 3334 8693
Email
zohreh.ghaemfar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Ghaem Far
Position
Student of master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Unit 10, Floor 4, Pakdaman Bldg, 17th Alley, Felestin St, Khajeh Ata Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916785418
Phone
+98 76 3334 8693
Email
zohreh.ghaemfar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Ghaem Far
Position
Student of master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Unit 10, Floor 4, Pakdaman Bldg, 17th Alley, Felestin St, Khajeh Ata Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916785418
Phone
+98 76 3334 8693
Email
zohreh.ghaemfar@gmail.com
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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I haven't decided yet. The release schedule is not clear yet.
When the data will become available and for how long
I haven't decided yet. The release schedule is not clear yet.
To whom data/document is available
I haven't decided yet. The release schedule is not clear yet.
Under which criteria data/document could be used
I haven't decided yet. The release schedule is not clear yet.
From where data/document is obtainable
I haven't decided yet. The release schedule is not clear yet.
What processes are involved for a request to access data/document
I haven't decided yet. The release schedule is not clear yet.