Potential Abnormality of Glucose ToleranceNCT05484323
Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses
A study testing Glucose as reference food, White bread and Cookie containing 0 g spirulina in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.
Trial summary
This study investigated the effects of cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Potential Abnormality of Glucose Tolerance, Appetitive Behavior, Blood Pressure
- What is being tested?
- Glucose as reference food, White bread and Cookie containing 0 g spirulina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jan 2022to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoking
- men and women
- body mass index between 18 and 24.9 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Glucose as reference food, White bread, Cookie containing 0 g spirulina, Cookie containing 2.5 g spirulina
- Keywords
- blood glucose responses, spirulina, blood glucose concentrations, glycemic index
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose as reference foodOther
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 breadOther
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.
Cookie containing 0 g spirulinaDiagnostic test
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.
Cookie containing 2.5 g spirulinaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucose as reference food | Experimental | 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. Receives: Other: Glucose as reference food; Other: White bread; Diagnostic Test: Cookie containing 0 g spirulina; Other: Cookie containing 2.5 g spirulina |
| White bread | Experimental | 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. Receives: Other: Glucose as reference food; Other: White bread; Diagnostic Test: Cookie containing 0 g spirulina; Other: Cookie containing 2.5 g spirulina |
| Cookie containing 0 g spirulina | Experimental | 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. Receives: Other: Glucose as reference food; Other: White bread; Diagnostic Test: Cookie containing 0 g spirulina; Other: Cookie containing 2.5 g spirulina |
| Cookie containing 2.5 g spirulina | Experimental | 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. Receives: Other: Glucose as reference food; Other: White bread; Diagnostic Test: Cookie containing 0 g spirulina; Other: Cookie containing 2.5 g spirulina |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (1)
Salivary insulin responses
Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 2hr glucose tolerance test
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start15 Jan 2022
- Primary completion28 Feb 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potential Abnormality of Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover, double blind, randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
- Investigators
- Emilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484323
- Sponsor's protocol ID
- HRBD 50 12/10/2021
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses: A Randomized Clinical Trial in Healthy Humans
- ClinicalTrials.gov ID
- NCT05484323
- Acronym / sponsor ID
- HRBD 50 12/10/2021
- Keywords
- blood glucose responses, spirulina, blood glucose concentrations, glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the effects of cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Crossover, double blind, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference food, Other: White bread, Diagnostic Test: Cookie containing 0 g spirulina, Other: Cookie containing 2.5 g spirulinaThirteen 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 | Experimental | Other: Glucose as reference food, Other: White bread, Diagnostic Test: Cookie containing 0 g spirulina, Other: Cookie containing 2.5 g spirulinaThirteen 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. |
| Cookie containing 0 g spirulina | Experimental | Other: Glucose as reference food, Other: White bread, Diagnostic Test: Cookie containing 0 g spirulina, Other: Cookie containing 2.5 g spirulinaThirteen 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. |
| Cookie containing 2.5 g spirulina | Experimental | Other: Glucose as reference food, Other: White bread, Diagnostic Test: Cookie containing 0 g spirulina, Other: Cookie containing 2.5 g spirulinaThirteen 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- non-smoking
- men and women
- body mass index between 18 and 24.9 kg/m2
Key exclusion criteria (7 listed)
- severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endrocrine conditions)
- gastrointestinal diseases
- pregnancy
- lactation
- competitive sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose as reference foodThirteen 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 0 g spirulina, Cookie containing 2.5 g spirulina, Glucose as reference food, White bread |
| White breadThirteen 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 0 g spirulina, Cookie containing 2.5 g spirulina, Glucose as reference food, White bread |
| Cookie containing 0 g spirulinaThirteen 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, Cookie containing 2.5 g spirulina, Glucose as reference food, White bread |
| Cookie containing 2.5 g spirulinaTThirteen 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 0 g spirulina, Cookie containing 2.5 g spirulina, Glucose as reference food, White bread |
Primary outcome
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
1 secondary outcome
Salivary insulin responses
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Papakonstantinou, PhD principal investigator
Agricultural University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose as reference food, White bread and Cookie containing 0 g spirulina in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood glucose responses (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.