Effects of Spirulina Supplementation on Overweight or Obese Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993627
• Other study ID #: IR.SBMU.nnftri.Rec.1395.63
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Spirulina
2 g(4* 500 mg tablets) daily intake of Spirulina Platensis

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

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. — View 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 — View 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, plac — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr	week 12
Primary	BMI	calculation	week 12
Primary	waist circumference	measuring with an inflexible tapeline with the precision of 0.1cm	week 12
Primary	hip circumference	measuring with an inflexible tapeline with the precision of 0.1cm	week 12
Primary	waist/hip ratio	calculation	week 12
Primary	body fat mass	bioempedance	week 12
Primary	body fat free mass	bioempedance	week 12
Primary	apetite	questionaire	week 12
Secondary	serum triaylglycerol	enzymatic method	week 12
Secondary	serum total cholesterol	enzymatic method	week 12
Secondary	e serum HDL-C	enzymatic method	week 12
Secondary	serum LDL-C	calculation	week 12
Secondary	serum LDL-C/HDL-C	calculation	week 12
Secondary	serum fasting glucose	enzymatic method	week 12
Secondary	serum insulin	enzymatic method	week 12
Secondary	HOMA-IR	calculation	week 12
Secondary	serum hs-CRP	eliza	week 12
Secondary	serum adiponectin	eliza	week 12
Secondary	serum SGOT	enzymatic method	week12
Secondary	serum SGPT	enzymatic method	week 12