Clinical trial NCT02575690: Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension
Official title: Effect of Spirulina Maxima Supplementation on Cardiovascular Risk in Obese Caucasians With Treated Hypertension:a Randomized Double-blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: spirulina, placebo, obesity,antihypertensive treatment
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body mass index
timeFrame: at baseline of the study
Secondary outcomes:
measure: blood pressure
timeFrame: At the baseline and following 3 months of treatment
measure: Body mass index
timeFrame: 3 months
measure: waist circumference
timeFrame: At the baseline and following 3 months of treatment
measure: serum lipids
timeFrame: At the baseline and following 3 months of treatment
measure: Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
timeFrame: At the baseline and following 3 months of treatment
measure: insulin estimated by immunoassay (DIAsource immunoassays)
timeFrame: At the baseline and following 3 months of treatment
measure: interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)
timeFrame: At the baseline and following 3 months of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Poznan University of Medical Sciences
name: Pawel Bogdanski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: