Potential Abnormality of Glucose ToleranceNCT05484336
Acute Effects of Spirulina on Postprandial Glycemic Responses and Arterial Blood Pressure
A study testing Glucose as reference food, Beverage containing 4g spirulina and Beverage containing 6g 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 three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety. 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, Beverage containing 4g spirulina and Beverage containing 6g spirulina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jun 2022to 26 Jul 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-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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Three Doses of Spirulina in Glucose Beverages on Postprandial Glycemic Responses, Arterial Blood Pressure, and Subjective Appetite Responses: A Randomized Clinical Trial
This study investigated the effects of three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety.
Read the detailed description
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.
- Being tested
- Glucose as reference food, Beverage containing 4g spirulina, Beverage containing 6g spirulina, Beverage containing 8g spirulina
- Keywords
- blood glucose responses, blood pressure, spirulina, subjective appetite, blood glucose concentrations
- 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, 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 spirulinaOther
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 spirulinaOther
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 spirulinaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Glucose as reference food; Other: Beverage containing 4g spirulina; Other: Beverage containing 6g spirulina; Other: Beverage containing 8g 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 2hr glucose tolerance test
Measured: 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
Measured: 2 hours
Secondary outcomes (1)
Subjective appetite ratings
Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120. 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.
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 start7 Jun 2022
- Primary completion15 Jul 2022
- Study completion26 Jul 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 Assignment
- 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
- NCT05484336
- Sponsor's protocol ID
- HRBD 54 06/06/2022
- 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 Three Doses of Spirulina in Glucose Beverages on Postprandial Glycemic Responses, Arterial Blood Pressure, and Subjective Appetite Responses: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05484336
- Acronym / sponsor ID
- HRBD 54 06/06/2022
- Keywords
- blood glucose responses, blood pressure, spirulina, subjective appetite, blood glucose concentrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 26 Jul 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 three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference food, Other: Beverage containing 4g spirulina, Other: Beverage containing 6g spirulina, Other: Beverage containing 8g spirulinaThirteen 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. |
| Glucose beverage containing 4 g spirulina | Experimental | Other: Glucose as reference food, Other: Beverage containing 4g spirulina, Other: Beverage containing 6g spirulina, Other: Beverage containing 8g spirulinaThirteen 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. |
| Glucose beverage containing 6 g spirulina | Experimental | Other: Glucose as reference food, Other: Beverage containing 4g spirulina, Other: Beverage containing 6g spirulina, Other: Beverage containing 8g spirulinaThirteen 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. |
| Glucose beverage containing 8 g spirulina | Experimental | Other: Glucose as reference food, Other: Beverage containing 4g spirulina, Other: Beverage containing 6g spirulina, Other: Beverage containing 8g spirulinaThirteen 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
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, 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. | Other | 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 spirulinaThirteen 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. | Other | 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 spirulinaThirteen 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. | Other | 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 spirulinaThirteen 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. | Other | Glucose as reference food, Glucose beverage containing 4 g spirulina, Glucose beverage containing 6 g spirulina, Glucose beverage containing 8 g spirulina |
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 2hr glucose tolerance test
Blood pressure
Time frame: 2 hours
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the three doses of spirulina in beverages
1 secondary outcome
Subjective appetite ratings
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, Beverage containing 4g spirulina and Beverage containing 6g 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 6 inclusion and 8 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). The study lists 2 primary outcomes in all. 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.