Potential Abnormality of Glucose ToleranceNCT05197283
Determining the Glycemic Effects of Three Types of Spaghetti
A study testing Glucose as reference food, White bread and Regular spaghetti 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 thee types of spaghetti No7 on the glycemic response 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, White bread and Regular spaghetti
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGreece
- Study dates
- 15 Oct 2021to 30 Dec 2021
- 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 disease (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: Determining the Effect of Three Types of Spaghetti (Regular, Whole Wheat and High Fiber-low Carbohydrates) on Glycemic Responses in Healthy Humans
This study investigated the effects of thee types of spaghetti No7 on the glycemic response
Read the detailed description
This study aimed to 1. determine the glycemic index and glycemic load of thee spaghetti No7 types (regular, whole wheat and high fiber-low carbohydrates) and 2. investigate the effects of these spaghetti types on postprandial glycemic response in healthy subjects
- Being tested
- Glucose as reference food, White bread, Regular spaghetti, Whole wheat spaghetti, High fibre - low carbohydrates spaghetti
- Keywords
- blood glucose, spaghetti, 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
Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested two times, in different visits, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
White breadOther
Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from white bread, along with 300ml water, tested two times, in different visits, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Regular spaghettiOther
Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from regular spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Whole wheat spaghettiOther
Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from whole wheat spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
High fibre - low carbohydrates spaghettiOther
Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from high fibre - low carbohydrate spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
| Study group | Role | What they receive |
|---|---|---|
| Glucose as reference food | Experimental | Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Glucose as reference food; Other: White bread; Other: Regular spaghetti; Other: Whole wheat spaghetti; Other: High fibre - low carbohydrates spaghetti |
| White bread | Experimental | Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Glucose as reference food; Other: White bread; Other: Regular spaghetti; Other: Whole wheat spaghetti; Other: High fibre - low carbohydrates spaghetti |
| Regular spaghetti No 7 | Experimental | Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Glucose as reference food; Other: White bread; Other: Regular spaghetti; Other: Whole wheat spaghetti; Other: High fibre - low carbohydrates spaghetti |
| Whole wheat spaghetti | Experimental | Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Glucose as reference food; Other: White bread; Other: Regular spaghetti; Other: Whole wheat spaghetti; Other: High fibre - low carbohydrates spaghetti |
| High fiber - low carbohydrate spaghetti | Experimental | Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. Receives: Other: Glucose as reference food; Other: White bread; Other: Regular spaghetti; Other: Whole wheat spaghetti; Other: High fibre - low carbohydrates spaghetti |
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 2hr glucose tolerance test
Measured: 2 hours
Secondary outcomes (3)
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
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 products
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 posted19 Jan 2022
- Study start15 Oct 2021
- Primary completion15 Dec 2021
- Study completion30 Dec 2021
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 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, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197283
- Sponsor's protocol ID
- HRBD 49 11/10/2021
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 19 Jan 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Three Types of Spaghetti (Regular, Whole Wheat and High Fiber-low Carbohydrates) on Glycemic Responses in Healthy Humans
- ClinicalTrials.gov ID
- NCT05197283
- Acronym / sponsor ID
- HRBD 49 11/10/2021
- Keywords
- blood glucose, spaghetti, glycemic index, glycemic load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 Jan 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 thee types of spaghetti No7 on the glycemic response
Detailed description
This study aimed to 1. determine the glycemic index and glycemic load of thee spaghetti No7 types (regular, whole wheat and high fiber-low carbohydrates) and 2. investigate the effects of these spaghetti types on postprandial glycemic response in healthy subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference food, Other: White bread, Other: Regular spaghetti, Other: Whole wheat spaghetti, Other: High fibre - low carbohydrates spaghettiFourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. |
| White bread | Experimental | Other: Glucose as reference food, Other: White bread, Other: Regular spaghetti, Other: Whole wheat spaghetti, Other: High fibre - low carbohydrates spaghettiFourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. |
| Regular spaghetti No 7 | Experimental | Other: Glucose as reference food, Other: White bread, Other: Regular spaghetti, Other: Whole wheat spaghetti, Other: High fibre - low carbohydrates spaghettiFourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. |
| Whole wheat spaghetti | Experimental | Other: Glucose as reference food, Other: White bread, Other: Regular spaghetti, Other: Whole wheat spaghetti, Other: High fibre - low carbohydrates spaghettiFourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink. |
| High fiber - low carbohydrate spaghetti | Experimental | Other: Glucose as reference food, Other: White bread, Other: Regular spaghetti, Other: Whole wheat spaghetti, Other: High fibre - low carbohydrates spaghettiFourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin 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 disease (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 foodFourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested two times, in different visits, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. | Other | Glucose as reference food, High fiber - low carbohydrate spaghetti, Regular spaghetti No 7, White bread, Whole wheat spaghetti |
| White breadFourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from white bread, along with 300ml water, tested two times, in different visits, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. | Other | Glucose as reference food, High fiber - low carbohydrate spaghetti, Regular spaghetti No 7, White bread, Whole wheat spaghetti |
| Regular spaghettiFourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from regular spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. | Other | Glucose as reference food, High fiber - low carbohydrate spaghetti, Regular spaghetti No 7, White bread, Whole wheat spaghetti |
| Whole wheat spaghettiFourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from whole wheat spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. | Other | Glucose as reference food, High fiber - low carbohydrate spaghetti, Regular spaghetti No 7, White bread, Whole wheat spaghetti |
| High fibre - low carbohydrates spaghettiFourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from high fibre - low carbohydrate spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. | Other | Glucose as reference food, High fiber - low carbohydrate spaghetti, Regular spaghetti No 7, White bread, Whole wheat spaghetti |
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 2hr glucose tolerance test
3 secondary outcomes
Salivary insulin responses
Time frame: 2 hours
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 19 Jan 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 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 Regular spaghetti 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 19 Jan 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 19 Jan 2022.