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ObesityNCT02993627

Effects of Spirulina Supplementation on Overweight or Obese Adults

A study testing Spirulina and diet therapy in people with Obesity, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Spirulina and diet therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteIran
Study dates
Dec 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

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

    Tehran, 1981619573

Other trials in Iran

About this study

Official title: Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers 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.

Read the 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.

Conditions
Obesity
Being tested
Spirulina, diet therapy
Keywords
obesity, BMI, body weight
Medical subject headings
Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpirulinaDietary supplement

    Also called Spiruvit

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

  • diet therapyOther

    Also called weight reduction diet

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

Study groups in NCT02993627
Study groupRoleWhat they receive
SpirulinaExperimentaldaily intake of spirulina tablets weight reduction diet therapy
Receives: Dietary Supplement: Spirulina; Other: diet therapy
placeboPlacebo comparatordaily intake of placebo tablets weight reduction diet therapy
Receives: Other: diet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight

    body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr

    Measured: week 12

  2. BMI

    calculation

    Measured: week 12

  3. waist circumference

    measuring with an inflexible tapeline with the precision of 0.1cm

    Measured: week 12

  4. hip circumference

    measuring with an inflexible tapeline with the precision of 0.1cm

    Measured: week 12

  5. waist/hip ratio

    calculation

    Measured: week 12

  6. body fat mass

    bioempedance

    Measured: week 12

  7. body fat free mass

    bioempedance

    Measured: week 12

  8. apetite

    questionaire

    Measured: week 12

Secondary outcomes (12)

  1. serum triaylglycerol

    enzymatic method

    Measured: week 12

  2. serum total cholesterol

    enzymatic method

    Measured: week 12

  3. e serum HDL-C

    enzymatic method

    Measured: week 12

  4. serum LDL-C

    calculation

    Measured: week 12

  5. serum LDL-C/HDL-C

    calculation

    Measured: week 12

  6. serum fasting glucose

    enzymatic method

    Measured: week 12

  7. serum insulin

    enzymatic method

    Measured: week 12

  8. HOMA-IR

    calculation

    Measured: week 12

  9. serum hs-CRP

    eliza

    Measured: week 12

  10. serum adiponectin

    eliza

    Measured: week 12

  11. serum SGOT

    enzymatic method

    Measured: week12

  12. serum SGPT

    enzymatic method

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJul 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993627
Sponsor's protocol ID
IR.SBMU.nnftri.Rec.1395.63
Status last verified
Apr 2019
First submitted
27 Nov 2016
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 18039384

  • 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.

    PubMed 18714150

  • 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.

    PubMed 12639401

  • 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.

    PubMed 26813468

  • 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.

    PubMed 25331487

  • 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.

    PubMed 20016733

Questions about this trial

What is this clinical trial studying?

A study testing Spirulina and diet therapy in people with Obesity, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight (time frame: week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993627, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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