- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484323
Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses
July 30, 2022 updated by: Aimilia Papakonstantinou, Agricultural University of Athens
Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses: A Randomized Clinical Trial in Healthy Humans
This study investigated the effects of cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses.
Study Overview
Status
Completed
Detailed 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
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Athens, Greece, 11855
- Agricultural University of Athens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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.
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.
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.
|
Experimental: 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.
|
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.
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.
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.
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.
|
Experimental: 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.
|
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.
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.
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.
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.
|
Experimental: Cookie containing 2.5 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.
|
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capillary blood glucose responses
Time Frame: 2 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary insulin responses
Time Frame: 2 hours
|
Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 2hr glucose tolerance test
|
2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite ratings
Time Frame: 2 hours
|
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
|
Blood pressure
Time Frame: 2 hours
|
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the cookie products
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2022
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
March 2, 2022
Study Registration Dates
First Submitted
July 30, 2022
First Submitted That Met QC Criteria
July 30, 2022
First Posted (Actual)
August 2, 2022
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 30, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRBD 50 12/10/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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