Potential Abnormality of Glucose ToleranceNCT05702372
Acute Glycemic Effects of Crackers Made by Different Flours
A study testing Glucose as reference food, Cracker made by wheat flour and Cracker made by rye flour 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 acute effects of cracker consumption made by different flours on glycemic 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
- What is being tested?
- Glucose as reference food, Cracker made by wheat flour and Cracker made by rye flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGreece
- Study dates
- 19 Sep 2022to 19 Jan 2023
- 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
- non-diabetic men and women
- body mass index between 18 and 25 kg/m2
Who cannot join
- severe chronic diseases (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
- gastrointestinal disorders
- pregnancy
- lactation
- competitive sports
- alcohol abuse
- drug dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Crackers on Glycemic Index and Glycemic Responses. A Randomized Trial in Healthy Adults
This study investigated the acute effects of cracker consumption made by different flours on glycemic responses.
Read the detailed description
This study aimed to determine the glycemic index and glycemic load of crackers made by different flours (wheat, whole wheat, and 30% sunflower seed flour substitution) and to investigate the effects of these types of crackers on postprandial glycemic responses in healthy humans. Moreover, blood pressure levels and subjective appetite were evaluated.
- Being tested
- Glucose as reference food, Cracker made by wheat flour, Cracker made by rye flour, Cracker made by sunflower flour
- Keywords
- blood glucose, crackers, glycemic index, glycemic load
- 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
Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Cracker made by wheat flourOther
Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by wheat flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Cracker made by rye flourOther
Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by rye flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Cracker made by sunflower flourOther
Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from sunflower flour, along with 300ml water, tested once, within 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 | Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Glucose as reference food |
| Cracker made by wheat flour | Experimental | Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Cracker made by wheat flour |
| Cracker made by rye flour | Experimental | Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Cracker made by rye flour |
| Cracker made by sunflower flour | Experimental | Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Cracker made by sunflower flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index
Glucose solution (50 g) was the reference food (GI = 100%) against which all test foods were compared. Subjects arrived at the laboratory at eight to nine o'clock in the morning after 10-12 h overnight fast. Each subject was fed equivalent 50 g available carbohydrate of test foods or reference food in random order. To minimize day to day variation of glucose tolerance, the reference food was tested in triplicate in each subject. All test and reference foods were served with 250 mL of water. An automatic lancet device and glucometer (calibrated MediSmart Ruby glucose meter with a lancing device, Lilly-PHARMASERV SA, Greece) was used for finger capillary blood samples. Blood samples were taken immediately before the start of the study (0 min) and 15, 30, 45, 60, 90 and 120 min after the start of eating.
Measured: 2 hours
Capillary blood glucose responses
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test
Measured: 2 hours
Secondary outcomes (2)
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
Measured: 2 hours
Blood pressure
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the spaghetti productws
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 posted27 Jan 2023
- Study start19 Sep 2022
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Technology and Agricultural Products
- 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
- NCT05702372
- Sponsor's protocol ID
- HRBD 80/12.10.2022
- Status last verified
- Jun 2024
- First submitted
- 19 Jan 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papakonstantinou E, Alsab V, Lympaki F, Chanioti S, Giannoglou M, Katsaros G. The acute effects of variations in the flour composition of crackers on the glycemic index and glycemic responses in healthy adults. Eur J Clin Nutr. 2024 Dec;78(12):1051-1057. doi: 10.1038/s41430-024-01482-0. Epub 2024 Aug 5.
PubMed 39103546
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Crackers on Glycemic Index and Glycemic Responses. A Randomized Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT05702372
- Acronym / sponsor ID
- HRBD 80/12.10.2022
- Keywords
- blood glucose, crackers, glycemic index, glycemic load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- Institute of Technology and Agricultural Products
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 27 Jan 2023 (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 acute effects of cracker consumption made by different flours on glycemic responses.
Detailed description
This study aimed to determine the glycemic index and glycemic load of crackers made by different flours (wheat, whole wheat, and 30% sunflower seed flour substitution) and to investigate the effects of these types of crackers on postprandial glycemic responses in healthy humans. Moreover, blood pressure levels and subjective appetite were evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference foodEleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
| Cracker made by wheat flour | Experimental | Other: Cracker made by wheat flourEleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
| Cracker made by rye flour | Experimental | Other: Cracker made by rye flourEleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
| Cracker made by sunflower flour | Experimental | Other: Cracker made by sunflower flourEleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min 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
- non-diabetic men and women
- body mass index between 18 and 25 kg/m2
Key exclusion criteria (7 listed)
- severe chronic diseases (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
- gastrointestinal disorders
- 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 foodEleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested three 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 |
| Cracker made by wheat flourEleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by wheat flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Cracker made by wheat flour |
| Cracker made by rye flourEleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by rye flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Cracker made by rye flour |
| Cracker made by sunflower flourEleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from sunflower flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Cracker made by sunflower flour |
Primary outcome
Glycemic index
Time frame: 2 hours
Glucose solution (50 g) was the reference food (GI = 100%) against which all test foods were compared. Subjects arrived at the laboratory at eight to nine o'clock in the morning after 10-12 h overnight fast. Each subject was fed equivalent 50 g available carbohydrate of test foods or reference food in random order. To minimize day to day variation of glucose tolerance, the reference food was tested in triplicate in each subject. All test and reference foods were served with 250 mL of water. An automatic lancet device and glucometer (calibrated MediSmart Ruby glucose meter with a lancing device, Lilly-PHARMASERV SA, Greece) was used for finger capillary blood samples. Blood samples were taken immediately before the start of the study (0 min) and 15, 30, 45, 60, 90 and 120 min after the start of eating.
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 2hr glucose tolerance test
2 secondary outcomes
Subjective appetite ratings
Time frame: 2 hours
Blood pressure
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 14 Jun 2024.
- Derived from this study: PubMed 39103546Papakonstantinou E, Alsab V, Lympaki F, Chanioti S, Giannoglou M, Katsaros G. The acute effects of variations in the flour composition of crackers on the glycemic index and glycemic responses in healthy adults. Eur J Clin Nutr. 2024 Dec;78(12):1051-1057. doi: 10.1038/s41430-024-01482-0. Epub 2024 Aug 5.
- 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, Cracker made by wheat flour and Cracker made by rye flour 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 14 Jun 2024. 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?
Glycemic index (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?
On the ClinicalTrials.gov record for NCT05702372, which also lists 1 linked publication.
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 14 Jun 2024.