Effects of Spirulina Supplementation on Overweight or Obese Adults
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Spirulina
diet therapy
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, BMI, body weight
Eligibility Criteria
Inclusion Criteria:
- BMI>25 kg/m2
- No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study
- No history of vitamin or antioxidant supplementation within 3 months before the study
- Giving written informed consent for participation
Exclusion Criteria:
- Having chronic kidney or hepatic disease except NAFLD
- Havig hypo or hyperthyroidism
- Having autoimmune and infectious disease
- weight reduction diet therapy within 6 month from the intervention
- Having more than 3kg weight change in recent 2 months
- Having recent surgery
- Taking anticoagulant drugs
Sites / Locations
- Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Spirulina
placebo
Arm Description
daily intake of spirulina tablets weight reduction diet therapy
daily intake of placebo tablets weight reduction diet therapy
Outcomes
Primary Outcome Measures
body weight
body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr
BMI
calculation
waist circumference
measuring with an inflexible tapeline with the precision of 0.1cm
hip circumference
measuring with an inflexible tapeline with the precision of 0.1cm
waist/hip ratio
calculation
body fat mass
bioempedance
body fat free mass
bioempedance
apetite
questionaire
Secondary Outcome Measures
serum triaylglycerol
enzymatic method
serum total cholesterol
enzymatic method
e serum HDL-C
enzymatic method
serum LDL-C
calculation
serum LDL-C/HDL-C
calculation
serum fasting glucose
enzymatic method
serum insulin
enzymatic method
HOMA-IR
calculation
serum hs-CRP
eliza
serum adiponectin
eliza
serum SGOT
enzymatic method
serum SGPT
enzymatic method
Full Information
NCT ID
NCT02993627
First Posted
November 27, 2016
Last Updated
April 10, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02993627
Brief Title
Effects of Spirulina Supplementation on Overweight or Obese Adults
Official Title
Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this double-blind Randomized Controlled Clinical Trial investigators are going to study the effects of Spirulina supplementation on anthropometric measurements, lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese adults.
Detailed Description
A sample of 40 obese and overweight subjects will be recruited from Nutrition And Diet Therapy Clinic Of Shahid Beheshti Medical University.
This study is a double-blind Randomized Controlled Clinical Trial, that subjects will be randomly allocated to spirulina or placebo group according to the Random permuted blocks within strata method based on BMI. Subjects will consume 2 g spirulina daily (4 tablets of 500mg), whereas the control group are going to receive identical placebo tablets. Subjects are asked to maintain their usual physical activity level during the intervention period and also avoid taking any other supplements or medications without consulting the investigators. Intervention period is designed to be 12 weeks that has been determined sufficient to record changes of study parameters. At the beginning of the study and after 12 weeks of intervention, morning blood samples will be collected after 12 h of fasting. Anthropometric parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention. Subjects will be followed through social network to ensure their compliance with the study. Furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, BMI, body weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spirulina
Arm Type
Experimental
Arm Description
daily intake of spirulina tablets weight reduction diet therapy
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
daily intake of placebo tablets weight reduction diet therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Spirulina
Other Intervention Name(s)
Spiruvit
Intervention Description
2 g(4* 500 mg tablets) daily intake of Spirulina Platensis
Intervention Type
Other
Intervention Name(s)
diet therapy
Other Intervention Name(s)
weight reduction diet
Intervention Description
low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
Primary Outcome Measure Information:
Title
body weight
Description
body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr
Time Frame
week 12
Title
BMI
Description
calculation
Time Frame
week 12
Title
waist circumference
Description
measuring with an inflexible tapeline with the precision of 0.1cm
Time Frame
week 12
Title
hip circumference
Description
measuring with an inflexible tapeline with the precision of 0.1cm
Time Frame
week 12
Title
waist/hip ratio
Description
calculation
Time Frame
week 12
Title
body fat mass
Description
bioempedance
Time Frame
week 12
Title
body fat free mass
Description
bioempedance
Time Frame
week 12
Title
apetite
Description
questionaire
Time Frame
week 12
Secondary Outcome Measure Information:
Title
serum triaylglycerol
Description
enzymatic method
Time Frame
week 12
Title
serum total cholesterol
Description
enzymatic method
Time Frame
week 12
Title
e serum HDL-C
Description
enzymatic method
Time Frame
week 12
Title
serum LDL-C
Description
calculation
Time Frame
week 12
Title
serum LDL-C/HDL-C
Description
calculation
Time Frame
week 12
Title
serum fasting glucose
Description
enzymatic method
Time Frame
week 12
Title
serum insulin
Description
enzymatic method
Time Frame
week 12
Title
HOMA-IR
Description
calculation
Time Frame
week 12
Title
serum hs-CRP
Description
eliza
Time Frame
week 12
Title
serum adiponectin
Description
eliza
Time Frame
week 12
Title
serum SGOT
Description
enzymatic method
Time Frame
week12
Title
serum SGPT
Description
enzymatic method
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>25 kg/m2
No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study
No history of vitamin or antioxidant supplementation within 3 months before the study
Giving written informed consent for participation
Exclusion Criteria:
Having chronic kidney or hepatic disease except NAFLD
Havig hypo or hyperthyroidism
Having autoimmune and infectious disease
weight reduction diet therapy within 6 month from the intervention
Having more than 3kg weight change in recent 2 months
Having recent surgery
Taking anticoagulant drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atoosa Saidpour
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences
City
Tehran
ZIP/Postal Code
1981619573
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18039384
Citation
Torres-Duran PV, Ferreira-Hermosillo A, Juarez-Oropeza MA. Antihyperlipemic and antihypertensive effects of Spirulina maxima in an open sample of Mexican population: a preliminary report. Lipids Health Dis. 2007 Nov 26;6:33. doi: 10.1186/1476-511X-6-33.
Results Reference
result
PubMed Identifier
18714150
Citation
Park HJ, Lee YJ, Ryu HK, Kim MH, Chung HW, Kim WY. A randomized double-blind, placebo-controlled study to establish the effects of spirulina in elderly Koreans. Ann Nutr Metab. 2008;52(4):322-8. doi: 10.1159/000151486. Epub 2008 Aug 19.
Results Reference
result
PubMed Identifier
12639401
Citation
Parikh P, Mani U, Iyer U. Role of Spirulina in the Control of Glycemia and Lipidemia in Type 2 Diabetes Mellitus. J Med Food. 2001 Winter;4(4):193-199. doi: 10.1089/10966200152744463.
Results Reference
result
PubMed Identifier
26813468
Citation
Miczke A, Szulinska M, Hansdorfer-Korzon R, Kregielska-Narozna M, Suliburska J, Walkowiak J, Bogdanski P. Effects of spirulina consumption on body weight, blood pressure, and endothelial function in overweight hypertensive Caucasians: a double-blind, placebo-controlled, randomized trial. Eur Rev Med Pharmacol Sci. 2016;20(1):150-6.
Results Reference
result
PubMed Identifier
25331487
Citation
Mazokopakis EE, Papadomanolaki MG, Fousteris AA, Kotsiris DA, Lampadakis IM, Ganotakis ES. The hepatoprotective and hypolipidemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population with non-alcoholic fatty liver disease: a prospective pilot study. Ann Gastroenterol. 2014;27(4):387-394.
Results Reference
result
PubMed Identifier
20016733
Citation
Lee EH, Park JE, Choi YJ, Huh KB, Kim WY. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients. Nutr Res Pract. 2008 Winter;2(4):295-300. doi: 10.4162/nrp.2008.2.4.295. Epub 2008 Dec 31.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://lipidworld.biomedcentral.com/articles/10.1186/1476-511X-6-33/
Available IPD/Information Identifier
18039384
Learn more about this trial
Effects of Spirulina Supplementation on Overweight or Obese Adults
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