Overview

This trial is active, not recruiting.

Condition obesity
Treatments spirulina, placebo
Sponsor Poznan University of Medical Sciences
Start date January 2013
End date May 2015
Trial size 150 participants
Trial identifier NCT02575690, 599/12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Obese patients with well-treated hypertension that receive placebo (pure microcrystalline cellulose)
placebo
Individuals receive a placebo daily, for 3 months.
(Experimental)
Obese patients with well-treated hypertension that receive Hawaiian spirulina (Cyanotech Corporation, Hawaii, US)
spirulina
Individuals receive 2 g of spirulina daily, for 3 months.

Primary Outcomes

Measure
Body mass index
time frame: at baseline of the study

Secondary Outcomes

Measure
blood pressure
time frame: At the baseline and following 3 months of treatment
Body mass index
time frame: 3 months
waist circumference
time frame: At the baseline and following 3 months of treatment
serum lipids
time frame: At the baseline and following 3 months of treatment
Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
time frame: At the baseline and following 3 months of treatment
insulin estimated by immunoassay (DIAsource immunoassays)
time frame: 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)
time frame: At the baseline and following 3 months of treatment

Eligibility Criteria

Male or female participants from 25 years up to 60 years old.

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

Additional Information

Official title Effect of Spirulina Maxima Supplementation on Cardiovascular Risk in Obese Caucasians With Treated Hypertension:a Randomized Double-blind Placebo-controlled Study
Principal investigator Pawel Bogdanski, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Poznan University of Medical Sciences.