1-Objectives: The effect of supplementation with Spirulina Platensis algae on serum vascular endothelial growth factor (VEGF) and lipid profile in obese individuals
2-Design: Double blinded randomized clinical trial
3-Setting and conduct: The individuals will enter the intervention by public call. Individuals would be divided into two groups of intervention and control, each one including 32 people and matched by age and sex. The participants would be asked not to make change in their diet and physical activity during the supplementation. At the beginning of intervention, the participants will fill the general information questionnaire and anthropometric assessment would be performed for them. To execute biochemical tests, 7 cc of venal blood would be taken from the individuals before the trail and after 12 weeks of supplementation. The serum status of VEGF and lipid profile would be assessed at the beginning of trail and after 12 weeks of supplement usage. 24 hour recall questionnaire would be completed for 3 days of week and the end of intervention.
4-Participants: Obese people with BMI ≥ 30 kg/m2 and in the age group of 20 to 50 who tend to co-operate in this research.
5-Intervention: 2 groups of intervention (receiver of Spirulina Platensis 500 mg tablet supplement for 12 weeks and 2 times a day) and control (receiver of placebo 500 mg tablet including starch with the same appearance of Spirulina supplement for 12 weeks and 2 times a day) each group including 32 people
6-Main outcome: 1- Serum status of vascular endothelial growth factor (VEGF) 2-serum lipid profile
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071219082N7
Registration date:2015-09-12, 1394/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-12, 1394/06/21
Registrant information
Name
Mahdieh Abbasalizad Farhangi
Name of organization / entity
Department of Community Nutrition School of Nutrition
Country
Iran (Islamic Republic of)
Phone
+98 413357580
Email address
abbasalizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supplementation with Spirulina Platensis Algae on Serum Vascular Endothelial Growth Factor (VEGF) and Lipid Profile in Obese Individuals
Public title
The Effect of Supplementation with Spirulina Algae on Growth Factor (VEGF) and Lipid Profile in Obese Individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
tendency to attend; obese individuals with BMI ≥ 30 kg/m2; age group of 20 to 50.
Exclusion criteria: history of renal disease; history of CVD; cancers; acute infections; recent surgeries; usage of weight effective drugs (hormone drugs); antidepressant drugs; diuretic drugs; antibiotics; glucocorticoids; usage of any supplements in the past 3 months; pregnancy; breast feeding; menopause; following weight loss diets in 3 months before and during the intervention.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Nutrition Faculty, Tabriz University of Medical Sciences
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Street, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2015-09-01, 1394/06/10
Ethics committee reference number
TBZMED.REC.1494.4.61
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
obesity,unspecified
Primary outcomes
1
Description
Serum vascular endothelial growth factor
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
ELISA
2
Description
Serum lipid profile
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
spectrophotometry,immunoturbidimetry
Secondary outcomes
1
Description
Energy intake, Macronutrients
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
24 hours recall questionnaire
Intervention groups
1
Description
Intervention group spirulina platensis algae supplement 500 mg, 2 tablets a day, during 12 weeks of intervention
Category
Treatment - Other
2
Description
Control group, placebo: 500 mg tablet containing starch with the same appearance of the Spiruina supplement, 2 times daily for12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik laboratory
Full name of responsible person
Hamidreza Hodjatzadeh
Street address
Nik laboratory, Mellat Square, Northern Ostad Hasan Banna Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical sciences
Full name of responsible person
Dr Alireza Ostad Rahimi
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, AttarSstreet, Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
faculty member
Other areas of specialty/work
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar Street, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 2292
Fax
Email
abbasalizadm@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
Ph.D
Other areas of specialty/work
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Street, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 2292
Fax
Email
Abbasalizam@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)