The Effect of Spirulina Platensis Algae Supplementation on Serum Concentration Macrophage Inhibitory Cytokine (MIC-1), Superoxide Dismutase (SOD) and Glutathione Peroxidase (GPX) and Appetite in Obese Individuals
Current study is performed in double blinded randomized clinical trial method in two groups of intervention and control with the aim of analyzing the effect of supplementation with Spirulina Platensis algae on serum status of Macrophage Inhibitory Cytokine-1 (MIC-1), Superoxide Dismutase (SOD) and Glutathione Peroxidase (GPX) and appetite in obese individuals. The obese individuals with BMI >30 kg/m2 and age range of 20 to 50 years will form the statistical society. Qualified individuals will enter the trial by public call. The aim and method of the study would be explained to them. After filling out the consent, individuals would be divided into two groups of intervention (recipient of two 500 mg Spirulina Platensis tablets daily) and placebo, each one including 32 people. The intervention group will consume 2 tablets of Spirulina Platensis and the control group will consume 2 tablets of placebo with the same appearance daily for 12 weeks. The attendance will be matched by age and sex. They will be asked to not to change their diet and physical activity during the supplementation. At the beginning of the study, the attendance will fill out the general information questionnaire and anthropometric assessments will be done for them. To carry out the biochemical assessment, 7 cc of venal blood will be depleted before the trial and after 12 weeks. The status of studied factors will be assessed at the beginning of the trial and 12 weeks after supplementation. 24 hours recall for 3 days of a week will be completed as well. They would be asked about consumption of the tablets once a week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071619082N8
Registration date:2015-09-30, 1394/07/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-30, 1394/07/08
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
Tabriz University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spirulina Platensis Algae Supplementation on Serum Concentration Macrophage Inhibitory Cytokine (MIC-1), Superoxide Dismutase (SOD) and Glutathione Peroxidase (GPX) and Appetite in Obese Individuals
Public title
The Effect of Spirulina Algae on Inflamation Status and Appetite in Obese Individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Tendency to attend the trial; BMI in the range of 30-39 kg/m2; age limit between 20 and 50 of years.
Exclusion criteria: History of GI disease, diabetes, infections, cancers and drug therapy; consumption of any antioxidant multi-vitamins, fiber and Omega 3 supplements 3 months before and during the trial; pregnancy and breast feeding; menopause; following weight loss diets 3 months before and during the trial; history of renal diseases, CVD and recent surgeries; consumption of weight effective drugs (hormones and antidepressant drugs), diuretics, antibiotics; effective drugs on inflammation status.
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
Tabriz University of Medical Sciences, Health and Nutrition Faculty
Street address
Health and Nutrition Faculty, Attar Street, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
TBZMED.REC.1394.429
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 Concentrtaion of Macrophage Inhibitory Cytokine-1 (MIC-1)
Timepoint
Before the intervention, 3 months after the intervention
Method of measurement
ELISA, pg/ml
2
Description
Superoxide Dismutase (SOD) status
Timepoint
Before the intervention, 3 months after the intervention
Method of measurement
Spectrophotometry, U/ml
3
Description
Glutathione Peroxidase (GPX) status
Timepoint
Before the intervention, 3 months after the intervention
Method of measurement
Spectrophotometry,Mu/ml
4
Description
Anthropometric parameters
Timepoint
Before the intervention, 3 months after the intervention
Method of measurement
Weight, kg; Height, cm
5
Description
Appetite
Timepoint
Before the intervention, 3 months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Energy intake, macronutrients
Timepoint
Before the intervention, 3 months after the intervention begins
Method of measurement
Questionnaire
2
Description
Physical activity
Timepoint
Before the intervention, 3 months after the intervention begins
Method of measurement
Questionnaire
Intervention groups
1
Description
Supplement group: Spirulina Platensis Algae supplement 500 mg, 2 tablets a day, during 12 weeks of intervention.
Category
Treatment - Other
2
Description
Placebo: The same az supplement in appearance, without chlorophyl, 500 mg, 2 tablets a day, during 12 weeks of intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sohrabali Bakhshi Public Health Center
Full name of responsible person
Street address
City
Shahriar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr Alireza Ostad Rahimi
Street address
Attar Street, 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
Tabriz University of Medical Science
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
Health and Nutrition Faculty of Tabriz University of Medical Science