Effects of Spirulina Supplementation on Overweight or Obese Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Spirulina
* Other: diet therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirulina<br>daily intake of spirulina tablets weight reduction diet therapy | Dietary Supplement: Spirulina<br>* 2 g(4* 500 mg tablets) daily intake of Spirulina Platensis<br>* Other names: Spiruvit;Other: diet therapy<br>* low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat<br>* Other names: weight reduction diet;|
| Placebo Comparator: placebo<br>daily intake of placebo tablets weight reduction diet therapy | Other: diet therapy<br>* low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat<br>* Other names: weight reduction diet;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, obesity, body weight