Obesity
Conditions
Keywords
spirulina, placebo, obesity,antihypertensive treatment
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTSpirulina
Individuals receive 2 g of spirulina daily, for 3 months.
OTHERPlacebo
Individuals receive a placebo daily, for 3 months.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index | at baseline of the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| blood pressure | 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 |
| Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit | At the baseline and following 3 months of treatment |
Outcome results
None listed