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OpenTrials
Completed

NCT Number: NCT02575690

Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina

Dietary Supplement

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

Placebo

Other

Individuals receive a placebo daily, for 3 months.

Primary outcomes

  1. Body mass index

    Time frame: at baseline of the study

Secondary outcomes

  1. blood pressure

    Time frame: At the baseline and following 3 months of treatment

  2. Body mass index

    Time frame: 3 months

  3. waist circumference

    Time frame: At the baseline and following 3 months of treatment

  4. serum lipids

    Time frame: At the baseline and following 3 months of treatment

  5. Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit

    Time frame: At the baseline and following 3 months of treatment

  6. insulin estimated by immunoassay (DIAsource immunoassays)

    Time frame: At the baseline and following 3 months of treatment

  7. 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

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 15, 2015
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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