Acute Effects of Spirulina on Postprandial Glycemic Responses and Arterial Blood Pressure

Blood Pressure Clinical Trial

Official title:

Acute Effects of Three Doses of Spirulina in Glucose Beverages on Postprandial Glycemic Responses, Arterial Blood Pressure, and Subjective Appetite Responses: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484336
• Other study ID #: HRBD 54 06/06/2022
• Status: Completed
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: July 26, 2022

Study information

• Verified date: July 2022
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigated the effects of three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety.

Description:

This study aimed to determine the effects of three different doses (4, 6 and 8 g) of spirulina in glucose beverages on postprandial glycemic responses, blood pressure, and subjective appetite responses in healthy young adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 26, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy

• non-smokers

• men and women

• body mass index between 18 and 24.9 kg/m2

• normal blood pressure (systolic blood pressure <120 mmHg and diastolic blood pressure <80 mmHg)

• normal fasting blood glucose concentrations (<100 mg/dL)

Exclusion Criteria:

• Medical conditions (e.g., cardiovascular diseases, diabetes mellitus, kidney or liver conditions, severe clinical depression, gastrointestinal disorders)

• Under medications known to affect glycemia (glucocorticoids, metformin, thiazide diuretics)

• Allergy to spirulina

• Pregnancy

• Lactation

• Competitive sports

• Alcohol abuse

• Drug dependency

Related Conditions & MeSH terms

• Appetitive Behavior
• Blood Pressure
• Congenital Abnormalities
• Potential Abnormality of Glucose Tolerance

Intervention

Other:
• Glucose as reference food
Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose diluted in 250ml, tested two times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
• Beverage containing 4g spirulina
Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose and 4g spirulina diluted in 250ml, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
• Beverage containing 6g spirulina
Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose and 6g spirulina diluted in 250ml, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
• Beverage containing 8g spirulina
Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose and 8g spirulina diluted in 250ml, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary blood glucose responses	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during 2hr glucose tolerance test	2 hours
Primary	Blood pressure	Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the three doses of spirulina in beverages	2 hours
Secondary	Subjective appetite ratings	Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g. hunger, satiety, desire to eat etc.	2 hours