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Effects of Spirulina Supplementation on Overweight or Obese Adults

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ClinicalTrials.gov Identifier: NCT02993627
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Atoosa Saidpour, Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Spirulina Other: diet therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Spirulina
daily intake of spirulina tablets weight reduction diet therapy
Dietary Supplement: Spirulina
2 g(4* 500 mg tablets) daily intake of Spirulina Platensis
Other Name: Spiruvit

Other: diet therapy
low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
Other Name: weight reduction diet

Placebo Comparator: placebo
daily intake of placebo tablets weight reduction diet therapy
Other: diet therapy
low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
Other Name: weight reduction diet




Primary Outcome Measures :
  1. body weight [ Time Frame: week 12 ]
    body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr

  2. BMI [ Time Frame: week 12 ]
    calculation

  3. waist circumference [ Time Frame: week 12 ]
    measuring with an inflexible tapeline with the precision of 0.1cm

  4. hip circumference [ Time Frame: week 12 ]
    measuring with an inflexible tapeline with the precision of 0.1cm

  5. waist/hip ratio [ Time Frame: week 12 ]
    calculation

  6. body fat mass [ Time Frame: week 12 ]
    bioempedance

  7. body fat free mass [ Time Frame: week 12 ]
    bioempedance

  8. apetite [ Time Frame: week 12 ]
    questionaire


Secondary Outcome Measures :
  1. serum triaylglycerol [ Time Frame: week 12 ]
    enzymatic method

  2. serum total cholesterol [ Time Frame: week 12 ]
    enzymatic method

  3. e serum HDL-C [ Time Frame: week 12 ]
    enzymatic method

  4. serum LDL-C [ Time Frame: week 12 ]
    calculation

  5. serum LDL-C/HDL-C [ Time Frame: week 12 ]
    calculation

  6. serum fasting glucose [ Time Frame: week 12 ]
    enzymatic method

  7. serum insulin [ Time Frame: week 12 ]
    enzymatic method

  8. HOMA-IR [ Time Frame: week 12 ]
    calculation

  9. serum hs-CRP [ Time Frame: week 12 ]
    eliza

  10. serum adiponectin [ Time Frame: week 12 ]
    eliza

  11. serum SGOT [ Time Frame: week12 ]
    enzymatic method

  12. serum SGPT [ Time Frame: week 12 ]
    enzymatic method



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993627


Locations
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Iran, Islamic Republic of
Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of, 1981619573
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Atoosa Saidpour Shahid Beheshti University of Medical Sciences
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 18039384

Publications of Results:

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Responsible Party: Atoosa Saidpour, Assistant Professor of Nutrition Science, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02993627    
Other Study ID Numbers: IR.SBMU.nnftri.Rec.1395.63
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Atoosa Saidpour, Shahid Beheshti University of Medical Sciences:
obesity
BMI
body weight
Additional relevant MeSH terms:
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Overweight
Body Weight