<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993627</url>
  </required_header>
  <id_info>
    <org_study_id>IR.SBMU.nnftri.Rec.1395.63</org_study_id>
    <nct_id>NCT02993627</nct_id>
  </id_info>
  <brief_title>Effects of Spirulina Supplementation on Overweight or Obese Adults</brief_title>
  <official_title>Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this double-blind Randomized Controlled Clinical Trial investigators are going to study&#xD;
      the effects of Spirulina supplementation on anthropometric measurements, lipid profile,&#xD;
      appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A sample of 40 obese and overweight subjects will be recruited from Nutrition And Diet&#xD;
      Therapy Clinic Of Shahid Beheshti Medical University.&#xD;
&#xD;
      This study is a double-blind Randomized Controlled Clinical Trial, that subjects will be&#xD;
      randomly allocated to spirulina or placebo group according to the Random permuted blocks&#xD;
      within strata method based on BMI. Subjects will consume 2 g spirulina daily (4 tablets of&#xD;
      500mg), whereas the control group are going to receive identical placebo tablets. Subjects&#xD;
      are asked to maintain their usual physical activity level during the intervention period and&#xD;
      also avoid taking any other supplements or medications without consulting the investigators.&#xD;
      Intervention period is designed to be 12 weeks that has been determined sufficient to record&#xD;
      changes of study parameters. At the beginning of the study and after 12 weeks of&#xD;
      intervention, morning blood samples will be collected after 12 h of fasting. Anthropometric&#xD;
      parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention.&#xD;
      Subjects will be followed through social network to ensure their compliance with the study.&#xD;
      Furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or&#xD;
      -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body weight</measure>
    <time_frame>week 12</time_frame>
    <description>body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>week 12</time_frame>
    <description>calculation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>waist circumference</measure>
    <time_frame>week 12</time_frame>
    <description>measuring with an inflexible tapeline with the precision of 0.1cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hip circumference</measure>
    <time_frame>week 12</time_frame>
    <description>measuring with an inflexible tapeline with the precision of 0.1cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>waist/hip ratio</measure>
    <time_frame>week 12</time_frame>
    <description>calculation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body fat mass</measure>
    <time_frame>week 12</time_frame>
    <description>bioempedance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body fat free mass</measure>
    <time_frame>week 12</time_frame>
    <description>bioempedance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>apetite</measure>
    <time_frame>week 12</time_frame>
    <description>questionaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum triaylglycerol</measure>
    <time_frame>week 12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum total cholesterol</measure>
    <time_frame>week 12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>e serum HDL-C</measure>
    <time_frame>week 12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum LDL-C</measure>
    <time_frame>week 12</time_frame>
    <description>calculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum LDL-C/HDL-C</measure>
    <time_frame>week 12</time_frame>
    <description>calculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum fasting glucose</measure>
    <time_frame>week 12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum insulin</measure>
    <time_frame>week 12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>week 12</time_frame>
    <description>calculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum hs-CRP</measure>
    <time_frame>week 12</time_frame>
    <description>eliza</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum adiponectin</measure>
    <time_frame>week 12</time_frame>
    <description>eliza</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum SGOT</measure>
    <time_frame>week12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum SGPT</measure>
    <time_frame>week 12</time_frame>
    <description>enzymatic method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Spirulina</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>daily intake of spirulina tablets weight reduction diet therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>daily intake of placebo tablets weight reduction diet therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Spirulina</intervention_name>
    <description>2 g(4* 500 mg tablets) daily intake of Spirulina Platensis</description>
    <arm_group_label>Spirulina</arm_group_label>
    <other_name>Spiruvit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diet therapy</intervention_name>
    <description>low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat</description>
    <arm_group_label>Spirulina</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
    <other_name>weight reduction diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;25 kg/m2&#xD;
&#xD;
          -  No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease&#xD;
             within 3 months before the study&#xD;
&#xD;
          -  No history of vitamin or antioxidant supplementation within 3 months before the study&#xD;
&#xD;
          -  Giving written informed consent for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having chronic kidney or hepatic disease except NAFLD&#xD;
&#xD;
          -  Havig hypo or hyperthyroidism&#xD;
&#xD;
          -  Having autoimmune and infectious disease&#xD;
&#xD;
          -  weight reduction diet therapy within 6 month from the intervention&#xD;
&#xD;
          -  Having more than 3kg weight change in recent 2 months&#xD;
&#xD;
          -  Having recent surgery&#xD;
&#xD;
          -  Taking anticoagulant drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Atoosa Saidpour</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences</name>
      <address>
        <city>Tehran</city>
        <zip>1981619573</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>18039384</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>18714150</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>12639401</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>26813468</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>25331487</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>20016733</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Atoosa Saidpour</investigator_full_name>
    <investigator_title>Assistant Professor of Nutrition Science</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>BMI</keyword>
  <keyword>body weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>18039384</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://lipidworld.biomedcentral.com/articles/10.1186/1476-511X-6-33/</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993627
org study id: IR.SBMU.nnftri.Rec.1395.63
nct id: NCT02993627
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: body weight
time frame: week 12
description: body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr
measure: BMI
time frame: week 12
description: calculation
measure: waist circumference
time frame: week 12
description: measuring with an inflexible tapeline with the precision of 0.1cm
measure: hip circumference
time frame: week 12
description: measuring with an inflexible tapeline with the precision of 0.1cm
measure: waist/hip ratio
time frame: week 12
description: calculation
measure: body fat mass
time frame: week 12
description: bioempedance
measure: body fat free mass
time frame: week 12
description: bioempedance
measure: apetite
time frame: week 12
description: questionaire
measure: serum triaylglycerol
time frame: week 12
description: enzymatic method
measure: serum total cholesterol
time frame: week 12
description: enzymatic method
measure: e serum HDL-C
time frame: week 12
description: enzymatic method
measure: serum LDL-C
time frame: week 12
description: calculation
measure: serum LDL-C/HDL-C
time frame: week 12
description: calculation
measure: serum fasting glucose
time frame: week 12
description: enzymatic method
measure: serum insulin
time frame: week 12
description: enzymatic method
measure: HOMA-IR
time frame: week 12
description: calculation
measure: serum hs-CRP
time frame: week 12
description: eliza
measure: serum adiponectin
time frame: week 12
description: eliza
measure: serum SGOT
time frame: week12
description: enzymatic method
measure: serum SGPT
time frame: week 12
description: enzymatic method
arm group label: Spirulina
arm group type: Experimental
description: daily intake of spirulina tablets weight reduction diet therapy
arm group label: placebo
arm group type: Placebo Comparator
description: daily intake of placebo tablets weight reduction diet therapy
intervention type: Dietary Supplement
intervention name: Spirulina
description: 2 g(4* 500 mg tablets) daily intake of Spirulina Platensis
arm group label: Spirulina
other name: Spiruvit
intervention type: Other
intervention name: diet therapy
description: low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
arm group label: Spirulina
arm group label: placebo
other name: weight reduction diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Atoosa Saidpour
role: Principal Investigator
affiliation: Shahid Beheshti University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
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.
PMID: 18039384
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.
PMID: 18714150
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.
PMID: 12639401
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.
PMID: 26813468
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.
PMID: 25331487
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.
PMID: 20016733
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Atoosa Saidpour
investigator title: Assistant Professor of Nutrition Science
mesh term: Overweight
sharing ipd: No
study doc: 