Effects of Spirulina Supplementation on Overweight or Obese Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Spirulina; Other: diet therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1981619573
    • Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Spiruvit; Other: diet therapy; low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat; Other Names: 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 Names: weight reduction diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr	week 12
BMI	calculation	week 12
waist circumference	measuring with an inflexible tapeline with the precision of 0.1cm	week 12
hip circumference	measuring with an inflexible tapeline with the precision of 0.1cm	week 12
waist/hip ratio	calculation	week 12
body fat mass	bioempedance	week 12
body fat free mass	bioempedance	week 12
apetite	questionaire	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum triaylglycerol	enzymatic method	week 12
serum total cholesterol	enzymatic method	week 12
e serum HDL-C	enzymatic method	week 12
serum LDL-C	calculation	week 12
serum LDL-C/HDL-C	calculation	week 12
serum fasting glucose	enzymatic method	week 12
serum insulin	enzymatic method	week 12
HOMA-IR	calculation	week 12
serum hs-CRP	eliza	week 12
serum adiponectin	eliza	week 12
serum SGOT	enzymatic method	week12
serum SGPT	enzymatic method	week 12

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Principal Investigator: Atoosa Saidpour, Shahid Beheshti University of Medical Sciences

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: obesity; BMI; body weight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: IR.SBMU.nnftri.Rec.1395.63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Clinical Study Report
   Information identifier: 18039384
2. Clinical Study Report