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

Primary Purpose

Potential Abnormality of Glucose Tolerance, Appetitive Behavior, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Glucose as reference food
Beverage containing 4g spirulina
Beverage containing 6g spirulina
Beverage containing 8g spirulina
Sponsored by
Agricultural University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Potential Abnormality of Glucose Tolerance focused on measuring blood glucose responses, blood pressure, spirulina, subjective appetite, blood glucose concentrations

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Agricultural University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Glucose as reference food

Glucose beverage containing 4 g spirulina

Glucose beverage containing 6 g spirulina

Glucose beverage containing 8 g spirulina

Arm Description

Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.

Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.

Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.

Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.

Outcomes

Primary Outcome Measures

Capillary blood glucose responses
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during 2hr glucose tolerance test
Blood pressure
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the three doses of spirulina in beverages

Secondary Outcome Measures

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.

Full Information

First Posted
July 30, 2022
Last Updated
July 30, 2022
Sponsor
Agricultural University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05484336
Brief Title
Acute Effects of Spirulina on Postprandial Glycemic Responses and Arterial Blood Pressure
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agricultural University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Abnormality of Glucose Tolerance, Appetitive Behavior, Blood Pressure
Keywords
blood glucose responses, blood pressure, spirulina, subjective appetite, blood glucose concentrations

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.
Arm Title
Glucose beverage containing 4 g spirulina
Arm Type
Experimental
Arm Description
Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.
Arm Title
Glucose beverage containing 6 g spirulina
Arm Type
Experimental
Arm Description
Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.
Arm Title
Glucose beverage containing 8 g spirulina
Arm Type
Experimental
Arm Description
Thirteen healthy young adults, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, two times, in different weeks as reference food along with 300 mL water; and 50 g available carbohydrates from beverages containing 4, 6 and 8 g spirulina, tested once, in different visits, along with 300 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120min postmeal. The first glucose sample was taken exactly 15min after the beginning of the consumption of the tested food.
Intervention Type
Other
Intervention Name(s)
Glucose as reference food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Beverage containing 4g spirulina
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Beverage containing 6g spirulina
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Beverage containing 8g spirulina
Intervention Description
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.
Primary Outcome Measure Information:
Title
Capillary blood glucose responses
Description
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during 2hr glucose tolerance test
Time Frame
2 hours
Title
Blood pressure
Description
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the three doses of spirulina in beverages
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Subjective appetite ratings
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia Papakonstantinou, PhD
Organizational Affiliation
Agricultural University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agricultural University of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11855
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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

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