Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Placebo; Dietary supplement: Spirulina

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Pawel Bogdanski, MD, PhD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: spirulina, placebo, obesity,antihypertensive treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 599/12