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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spirulina | Experimental | daily intake of spirulina tablets weight reduction diet therapy |
|
| placebo | Placebo Comparator | daily intake of placebo tablets weight reduction diet therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirulina | Dietary Supplement | 2 g(4* 500 mg tablets) daily intake of Spirulina Platensis |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| serum triaylglycerol | enzymatic method | week 12 |
| serum total cholesterol | enzymatic method | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atoosa Saidpour | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences | Tehran | 1981619573 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18039384 | Result | 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. | |
| 18714150 | Result | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 18039384 | Clinical Study Report | View IPD |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D004038 | Diet, Reducing |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
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| diet therapy | Other | low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat |
|
|
| 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 |
| 12639401 | Result | 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. |
| 26813468 | Result | 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. |
| 25331487 | Result | 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. |
| 20016733 | Result | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |