Clinical trial NCT02993627: Effects of Spirulina Supplementation on Overweight or Obese Adults
Official title: Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
BMI
body weight
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: body weight
timeFrame: week 12
measure: BMI
timeFrame: week 12
measure: waist circumference
timeFrame: week 12
measure: hip circumference
timeFrame: week 12
measure: waist/hip ratio
timeFrame: week 12
measure: body fat mass
timeFrame: week 12
measure: body fat free mass
timeFrame: week 12
measure: apetite
timeFrame: week 12
Secondary outcomes:
measure: serum triaylglycerol
timeFrame: week 12
measure: serum total cholesterol
timeFrame: week 12
measure: e serum HDL-C
timeFrame: week 12
measure: serum LDL-C
timeFrame: week 12
measure: serum LDL-C/HDL-C
timeFrame: week 12
measure: serum fasting glucose
timeFrame: week 12
measure: serum insulin
timeFrame: week 12
measure: HOMA-IR
timeFrame: week 12
measure: serum hs-CRP
timeFrame: week 12
measure: serum adiponectin
timeFrame: week 12
measure: serum SGOT
timeFrame: week12
measure: serum SGPT
timeFrame: week 12
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Atoosa Saidpour
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1186/1476-511X-6-33.
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.
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. doi: 10.1089/10966200152744463.
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, placebo-controlled, randomized trial. Eur Rev Med Pharmacol Sci. 2016;20(1):150-6.
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 prospective pilot study. Ann Gastroenterol. 2014;27(4):387-394.
citation: 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.