Effect of Spirulina Maxima Supplementation on Cardiovascular Risk in Obese Caucasians With Treated Hypertension:a Randomized Double-blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Body mass index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •secondary obesity or secondary hypertension
- •a history of coronary artery disease
- •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
结局指标
主要结局
Body mass index
时间窗: at baseline of the study
次要结局
- blood pressure(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)
- Body mass index(3 months)
- 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)
- waist circumference(At the baseline and following 3 months of treatment)
- insulin estimated by immunoassay (DIAsource immunoassays)(At the baseline and following 3 months of treatment)
研究者
Pawel Bogdanski
Associate professor
Poznan University of Medical Sciences