Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

NCT ID: NCT02575690

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

Obese patients with well-treated hypertension that receive placebo (pure microcrystalline cellulose)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Individuals receive a placebo daily, for 3 months.

Spirulina group

Obese patients with well-treated hypertension that receive Hawaiian spirulina (Cyanotech Corporation, Hawaii, US)

Group Type: EXPERIMENTAL

Spirulina

Intervention Type: DIETARY_SUPPLEMENT

Individuals receive 2 g of spirulina daily, for 3 months.

Interventions

Spirulina

Individuals receive 2 g of spirulina daily, for 3 months.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Individuals receive a placebo daily, for 3 months.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Pawel Bogdanski

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pawel Bogdanski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Medical Sciences

Other Identifiers

599/12

Identifier Type: -

Identifier Source: org_study_id