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Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spirulina
Placebo
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring spirulina, placebo, obesity,antihypertensive treatment

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo group

    Spirulina group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Body mass index

    Secondary Outcome Measures

    blood pressure
    Body mass index
    waist circumference
    serum lipids
    Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
    insulin estimated by immunoassay (DIAsource immunoassays)
    interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)

    Full Information

    First Posted
    October 8, 2015
    Last Updated
    May 4, 2020
    Sponsor
    Poznan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02575690
    Brief Title
    Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension
    Official Title
    Effect of Spirulina Maxima Supplementation on Cardiovascular Risk in Obese Caucasians With Treated Hypertension:a Randomized Double-blind Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Poznan University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    spirulina, placebo, obesity,antihypertensive treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Obese patients with well-treated hypertension that receive placebo (pure microcrystalline cellulose)
    Arm Title
    Spirulina group
    Arm Type
    Experimental
    Arm Description
    Obese patients with well-treated hypertension that receive Hawaiian spirulina (Cyanotech Corporation, Hawaii, US)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Spirulina
    Intervention Description
    Individuals receive 2 g of spirulina daily, for 3 months.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Individuals receive a placebo daily, for 3 months.
    Primary Outcome Measure Information:
    Title
    Body mass index
    Time Frame
    at baseline of the study
    Secondary Outcome Measure Information:
    Title
    blood pressure
    Time Frame
    At the baseline and following 3 months of treatment
    Title
    Body mass index
    Time Frame
    3 months
    Title
    waist circumference
    Time Frame
    At the baseline and following 3 months of treatment
    Title
    serum lipids
    Time Frame
    At the baseline and following 3 months of treatment
    Title
    Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
    Time Frame
    At the baseline and following 3 months of treatment
    Title
    insulin estimated by immunoassay (DIAsource immunoassays)
    Time Frame
    At the baseline and following 3 months of treatment
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pawel Bogdanski, MD, PhD
    Organizational Affiliation
    Poznan University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

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