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

NCT ID: NCT05484336

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2022-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Potential Abnormality of Glucose Tolerance Appetitive Behavior Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glucose beverage containing 8 g spirulina

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Glucose as reference 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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Glucose beverage containing 4 g spirulina

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Glucose beverage containing 6 g spirulina

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agricultural University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aimilia Papakonstantinou

Assistant Professor in Nutrition and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emilia Papakonstantinou, PhD

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Agricultural University of Athens

Athens, Attica, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRBD 54 06/06/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Green Tea on Cardiometabolic Outcomes
NCT06795438 NOT_YET_RECRUITING NA