Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

Study Overview
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Brief Summary
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Potential protective cardiovascular effect of Spirulina maxima supplementation was studied in a double-blind placebo-controlled trial of obese subjects with treated hypertension, each randomized to receive spirulina or a placebo.

Detailed Description
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Numerous publications have provided evidence of the effect of natural substances-supplements on improving endothelial function, and thus reducing the risk of cardiovascular diseases. Spirulina maxima (Arthrospira maxima) is a species of cyanobacterium, used as food additive because of its high levels of protein and essential nutrients, such as carotenoids, vitamins, and minerals. Various studies point to a possible beneficial effect of spirulina on the concentration of blood serum lipids and fasting glucose,body weight or blood pressure, however, the results of studies pertained to the effects of spirulina in individuals who, at the time of trial, were not taking medications. The aim of the study was to estimate an effect of Spirulina maxima supplementation on cardiovascular risk in obese Caucasians with treated hypertension. The anthropometric parameters, blood pressure, insulin sensitivity, plasma lipid levels, and stress oxidative biomarkers were measured at the baseline and after 3 months of supplementation with spirulina or placebo in the group of obese, hypertensive patients receiving standard antihypertensive treatment.

Official Title
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Effect of Spirulina Maxima Supplementation on Cardiovascular Risk in Obese Caucasians With Treated Hypertension:a Randomized Double-blind Placebo-controlled Study

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Spirulina
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) equal to or greater than 30 kg/m2 age 25 to 60 years stable body weight (< 3 kg self-reported change during the previous three months) well-controlled hypertension (meaning systolic blood pressure (SBP) less than 160 mmHg and/or diastolic blood pressure (DBP) less than 100 mmHg) with stable treatment for at least 6 months (the patients received one drug only) Exclusion Criteria: secondary obesity or secondary hypertension diabetes a history of coronary artery disease stroke congestive heart failure malignancy a history of use of any dietary supplements within the three months prior to the study a current need for modification of antihypertensive therapy abnormal liver or kidney function any clinically significant process a history of infection in the month prior to the study nicotine or alcohol abuse or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified efficacy assessments

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Obese patients with well-treated hypertension that receive placebo (pure microcrystalline cellulose) | Other: Placebo<br>* Individuals receive a placebo daily, for 3 months.<br>|
| Experimental: Spirulina group<br>Obese patients with well-treated hypertension that receive Hawaiian spirulina (Cyanotech Corporation, Hawaii, US) | Dietary Supplement: Spirulina<br>* Individuals receive 2 g of spirulina daily, for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | at baseline of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | At the baseline and following 3 months of treatment | 
| Body mass index |  | 3 months | 
| waist circumference |  | At the baseline and following 3 months of treatment | 
| serum lipids |  | At the baseline and following 3 months of treatment | 
| Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit |  | At the baseline and following 3 months of treatment | 
| insulin estimated by immunoassay (DIAsource immunoassays) |  | At the baseline and following 3 months of treatment | 
| interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit) |  | At the baseline and following 3 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spirulina, placebo, obesity,antihypertensive treatment