Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

NCT02575690 | Completed

• 1 other identifier: 599/12
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

spirulina, placebo, obesity,antihypertensive treatment

Outcome Measures

Primary Outcomes (1)

• Body mass index

  at baseline of the study

Secondary Outcomes (7)

• blood pressure

  At the baseline and following 3 months of treatment

• Body mass index

  3 months

• waist circumference

  At the baseline and following 3 months of treatment

• 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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Spirulina group

EXPERIMENTAL

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

Dietary Supplement: Spirulina

Interventions

Spirulina DIETARY_SUPPLEMENT

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

Spirulina group

Placebo OTHER

Individuals receive a placebo daily, for 3 months.

Placebo group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pawel Bogdanski, MD, PhD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 15, 2015
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 5, 2020

Record last verified: 2020-05