Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

Poznan University of Medical Sciences (PUMS)

Status

Completed

Conditions

Obesity

Treatments

Other: Placebo

Dietary Supplement: Spirulina

Study type

Interventional

Funder types

Other

Identifiers

NCT02575690

599/12

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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