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Completed

NCT Number: NCT02993627

Effects of Spirulina Supplementation on Overweight or Obese Adults

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences

Tehran, 1981619573, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina

Dietary Supplement

2 g(4* 500 mg tablets) daily intake of Spirulina Platensis

Other names: Spiruvit

Diet therapy

Other

low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat

Other names: weight reduction diet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2016
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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