Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses

Blood Pressure Clinical Trial

Official title:

Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses: A Randomized Clinical Trial in Healthy Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484323
• Other study ID #: HRBD 50 12/10/2021
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: March 2, 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 cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses.

Description:

This study examined the short-term effects of cookies containing 0 and 2.5 g Spirulina on postprandial glycemic and insulin responses, arterial blood pressure and subjective appetite

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy

• non-smoking

• men and women

• body mass index between 18 and 24.9 kg/m2

Exclusion Criteria:

• severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endrocrine conditions)

• gastrointestinal diseases

• 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 participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.
• White bread
Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

Diagnostic Test:
• Cookie containing 0 g spirulina
Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

Other:
• Cookie containing 2.5 g spirulina
TThirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective appetite ratings	Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120min. 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
Other	Blood pressure	Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the cookie products	2 hours
Primary	Capillary blood glucose responses	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2 hr glucose tolerance test	2 hours
Secondary	Salivary insulin responses	Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 2hr glucose tolerance test	2 hours