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

NCT05484336 | Completed DMC

• 1 other identifier: HRBD 54 06/06/2022
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Potential Abnormality of Glucose Tolerance; Appetitive Behavior; Blood Pressure

Keywords

blood glucose responses; blood pressure; spirulina; subjective appetite; blood glucose concentrations

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Subjective appetite ratings

  2 hours

Study Arms (4)

Glucose as reference food

EXPERIMENTAL

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.

Other: Glucose as reference food; Other: Beverage containing 4g spirulina; Other: Beverage containing 6g spirulina; Other: Beverage containing 8g spirulina

Glucose beverage containing 4 g spirulina

EXPERIMENTAL

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.

Other: Glucose as reference food; Other: Beverage containing 4g spirulina; Other: Beverage containing 6g spirulina; Other: Beverage containing 8g spirulina

Glucose beverage containing 6 g spirulina

EXPERIMENTAL

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.

Other: Glucose as reference food; Other: Beverage containing 4g spirulina; Other: Beverage containing 6g spirulina; Other: Beverage containing 8g spirulina

Glucose beverage containing 8 g spirulina

EXPERIMENTAL

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.

Other: Glucose as reference food; Other: Beverage containing 4g spirulina; Other: Beverage containing 6g spirulina; Other: Beverage containing 8g spirulina

Interventions

Glucose as reference food 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.

Glucose as reference food; Glucose beverage containing 4 g spirulina; Glucose beverage containing 6 g spirulina; Glucose beverage containing 8 g spirulina

Beverage containing 4g spirulina 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.

Glucose as reference food; Glucose beverage containing 4 g spirulina; Glucose beverage containing 6 g spirulina; Glucose beverage containing 8 g spirulina

Beverage containing 6g spirulina 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.

Glucose as reference food; Glucose beverage containing 4 g spirulina; Glucose beverage containing 6 g spirulina; Glucose beverage containing 8 g spirulina

Beverage containing 8g spirulina 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; Glucose beverage containing 4 g spirulina; Glucose beverage containing 6 g spirulina; Glucose beverage containing 8 g spirulina

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Emilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Nutrition and Metabolism

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: June 7, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 26, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)