Glycemic and Insulinemic ResponseGR-CEPNCT06994403
Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People
A study testing Durum wheat pasta enriched with carob flour, Standard durum wheat pasta and White bread reference meal in people with Glycemic and Insulinemic Response and Type 1 Diabetes (T1D), run by Federico II University at 1 site in Italy.
Trial summary
Carob (Ceratonia siliqua) is a fruit traditionally used in various Mediterranean countries for the preparation of sweets and beverages. Its pulp, once the seeds are removed, is milled into carob flour, a nutrient-rich food containing fiber, carbohydrates, proteins, and essential minerals such as potassium, magnesium… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycemic and Insulinemic Response, Type 1 Diabetes (T1D)
- What is being tested?
- Durum wheat pasta enriched with carob flour, Standard durum wheat pasta and White bread reference meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study 1
- Healthy male volunteers
- Age between 18 and 50 years
- Body Mass Index (BMI) between 18 and 29 kg/m²
- Study 2
- Male and female individuals
Show all 9Show fewer
- Age ≥ 18 years
- Confirmed diagnosis of type 1 diabetes mellitus
- Use of a continuous glucose monitoring (CGM) system
Who cannot join
- Study 1
- Diagnosis of diabetes mellitus
- Presence of any chronic-degenerative disease
- Any acute or chronic medical condition that could seriously compromise overall health
- Diagnosis of celiac disease
- Study 2
Show all 10Show fewer
- Presence of serious chronic illnesses (e.g., coronary heart disease, renal failure, liver diseases, endocrine disorders)
- Gastrointestinal disorders
- Pregnancy or breastfeeding
- Alcohol or drug dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II University
Naples, 80131
Lutgarda Bozzetto, +393333561105, lutgarda.bozzetto@unina.it
About this study
Official title: Evaluation of the Glycemic Response to a Pasta Enriched With Carob Flour: a Study Conducted in Healthy Subjects and a Study Conducted in Subjects With Type 1 Diabetes Mellitus
Carob (Ceratonia siliqua) is a fruit traditionally used in various Mediterranean countries for the preparation of sweets and beverages. Its pulp, once the seeds are removed, is milled into carob flour, a nutrient-rich food containing fiber, carbohydrates, proteins, and essential minerals such as potassium, magnesium, sodium, phosphorus, and calcium. Carob flour is also naturally sweet and can serve as a cocoa powder substitute in desserts. Furthermore, it is a source of polyphenols with known antioxidant properties.
Clinical evidence suggests that consumption of foods rich in refined carbohydrates is associated with elevated postprandial blood glucose levels, which are recognized as an independent cardiovascular risk factor. The glycemic index (GI) is a useful parameter to assess the impact of carbohydrate-containing foods on postprandial glycemic response. Based on carbohydrate quality, foods are classified as having high, medium, or low GI. Consumption of high-GI foods leads to a stronger glycemic response and has been linked to increased risk of chronic conditions such as type 2 diabetes, obesity, and cardiovascular disease.
Read more
Given its bromatological profile, carob flour may have the potential to modulate postprandial glycemic responses. However, studies evaluating the GI of carob-based products have shown inconsistent findings. In one randomized trial involving 10 healthy adults, a carob-based snack demonstrated a lower GI (40) compared to a chocolate cookie with an equivalent carbohydrate content (GI 78), using glucose as the reference. The same study found that consuming the carob snack before a meal led to a reduced postprandial glycemic response, decreased hunger, and lower caloric intake at an ad libitum meal. Another study on 7 healthy individuals reported a GI of 39 for carob flour bars containing 26 g of available carbohydrates. Conversely, a study involving 20 healthy participants found that consuming 5 or 10 g of carob pulp with 200 mL of water and 50 g glucose increased postprandial glycemic and insulinemic responses compared to water and glucose alone. This effect was not observed with a 20 g dose of carob pulp.
Among carbohydrate-rich foods, pasta represents a key component of the Italian diet and, due to its physical structure, generally has a low-to-moderate GI. Compared to other wheat-based foods like bread, pasta tends to produce a lower postprandial glycemic response when carbohydrate content is matched. However, the impact of adding carob flour to durum wheat semolina in pasta production on postprandial glycemia remains unexplored.
The current research project consists of two studies. The first study aims to determine the glycemic index of carob-enriched durum wheat pasta in healthy adult volunteers, using white bread as the reference food. The second study investigates the postprandial glycemic response to the same carob-enriched pasta in individuals with type 1 diabetes, comparing it to traditional durum wheat pasta. These studies are designed to contribute to the understanding of carob flour's role in glycemic control, with potential implications for dietary management in both healthy individuals and patients with diabetes.
Read the detailed description
Study 1:
This randomized, controlled, crossover trial aims to determine the glycemic index (GI) of a durum wheat pasta enriched with carob flour in healthy adult males. Over a period of three months, participants will consume test meals on separate days under controlled conditions. The glycemic response will be compared to that elicited by white bread, which serves as the reference food. This study is conducted in an outpatient setting and will contribute to the evaluation of the metabolic impact of carob-enriched pasta on postprandial glycemia.
Study 2:
This controlled, crossover study is designed to assess the postprandial glycemic response to carob flour-enriched pasta in individuals with type 1 diabetes using continuous glucose monitoring (CGM). Conducted over a 12-month period, the study involves alternating consumption of carob-enriched and standard durum wheat pasta. Participants will follow their usual dietary habits while maintaining consistent meal composition and daily routines during the test days. The study aims to explore the potential of carob-enriched pasta to modulate postprandial glycemia in a population with impaired glucose regulation.
- Being tested
- Durum wheat pasta enriched with carob flour, Standard durum wheat pasta, White bread reference meal
- Keywords
- Ceratonia siliqua, Glycemic Index, Type 1 Diabetes, Functional Foods, Postprandial Glycemia
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durum wheat pasta enriched with carob flourDietary supplement
Participants will consume 68 g of durum wheat pasta enriched with carob flour (231 kcal), providing 50 g of available carbohydrates. The pasta will be served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.
Standard durum wheat pastaDietary supplement
Participants will consume 63 g of standard durum wheat pasta (221 kcal), providing 50 g of available carbohydrates. The pasta will be served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.
White bread reference mealDietary supplement
Participants will consume 84 g of white bread (225 kcal), providing 50 g of available carbohydrates. The bread will be served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.
| Study group | Role | What they receive |
|---|---|---|
| Carob-Enriched Durum Wheat Pasta | Experimental | Participants will consume 68 g of carob-enriched durum wheat pasta (231 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. Receives: Dietary Supplement: Durum wheat pasta enriched with carob flour; Dietary Supplement: Standard durum wheat pasta; Dietary Supplement: White bread reference meal |
| Durum Wheat Pasta | Sham comparator | Participants will consume 63 g of traditional durum wheat pasta (221 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. Receives: Dietary Supplement: Durum wheat pasta enriched with carob flour; Dietary Supplement: Standard durum wheat pasta; Dietary Supplement: White bread reference meal |
| White Bread (Reference Food) | Active comparator | Participants will consume 84 g of white bread (225 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. Receives: Dietary Supplement: Durum wheat pasta enriched with carob flour; Dietary Supplement: Standard durum wheat pasta; Dietary Supplement: White bread reference meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Index of Carob-Enriched Durum Wheat Pasta
The primary outcome is the determination of the glycemic index (GI) of a carob-enriched durum wheat pasta compared to white bread, used as the reference food. The glycemic response will be assessed through blood glucose concentrations measured at fasting and at 15, 30, 60, 90, and 120 minutes after consumption.
Measured: Within 2 hours after consumption of the test meal on three separate test days (each separated by at least 2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start4 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic and Insulinemic ResponseStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lutgarda Bozzetto, Federico II University
- Investigators
- Giuseppina Costabile, Study chair, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994403
- Sponsor's protocol ID
- 32/2023
- Acronym
- GR-CEP
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Glycemic Response to a Pasta Enriched With Carob Flour: a Study Conducted in Healthy Subjects and a Study Conducted in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06994403
- Acronym / sponsor ID
- GR-CEP / 32/2023
- Keywords
- Ceratonia siliqua, Glycemic Index, Type 1 Diabetes, Functional Foods, Postprandial Glycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 May 2025 (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.
Carob (Ceratonia siliqua) is a fruit traditionally used in various Mediterranean countries for the preparation of sweets and beverages. Its pulp, once the seeds are removed, is milled into carob flour, a nutrient-rich food containing fiber, carbohydrates, proteins, and essential minerals such as potassium, magnesium, sodium, phosphorus, and calcium. Carob flour is also naturally sweet and can serve as a cocoa powder substitute in desserts. Furthermore, it is a source of polyphenols with known antioxidant properties.
Clinical evidence suggests that consumption of foods rich in refined carbohydrates is associated with elevated postprandial blood glucose levels, which are recognized as an independent cardiovascular risk factor. The glycemic index (GI) is a useful parameter to assess the impact of carbohydrate-containing foods on postprandial glycemic response. Based on carbohydrate quality, foods are classified as having high, medium, or low GI. Consumption of high-GI foods leads to a stronger glycemic response and has been linked to increased risk of chronic conditions such as type 2 diabetes, obesity, and cardiovascular disease.
Given its bromatological profile, carob flour may have the potential to modulate postprandial glycemic responses. However, studies evaluating the GI of carob-based products have shown inconsistent findings. In one randomized trial involving 10 healthy adults, a carob-based snack demonstrated a lower GI (40) compared to a chocolate cookie with an equivalent carbohydrate content (GI 78), using glucose as the reference. The same study found that consuming the carob snack before a meal led to a reduced postprandial glycemic response, decreased hunger, and lower caloric intake at an ad libitum meal. Another study on 7 healthy individuals reported a GI of 39 for carob flour bars containing 26 g of available carbohydrates. Conversely, a study involving 20 healthy participants found that consuming 5 or 10 g of carob pulp with 200 mL of water and 50 g glucose increased postprandial glycemic and insulinemic responses compared to water and glucose alone. This effect was not observed with a 20 g dose of carob pulp.
Among carbohydrate-rich foods, pasta represents a key component of the Italian diet and, due to its physical structure, generally has a low-to-moderate GI. Compared to other wheat-based foods like bread, pasta tends to produce a lower postprandial glycemic response when carbohydrate content is matched. However, the impact of adding carob flour to durum wheat semolina in pasta production on postprandial glycemia remains unexplored.
The current research project consists of two studies. The first study aims to determine the glycemic index of carob-enriched durum wheat pasta in healthy adult volunteers, using white bread as the reference food. The second study investigates the postprandial glycemic response to the same carob-enriched pasta in individuals with type 1 diabetes, comparing it to traditional durum wheat pasta. These studies are designed to contribute to the understanding of carob flour's role in glycemic control, with potential implications for dietary management in both healthy individuals and patients with diabetes.
Detailed description
Study 1:
This randomized, controlled, crossover trial aims to determine the glycemic index (GI) of a durum wheat pasta enriched with carob flour in healthy adult males. Over a period of three months, participants will consume test meals on separate days under controlled conditions. The glycemic response will be compared to that elicited by white bread, which serves as the reference food. This study is conducted in an outpatient setting and will contribute to the evaluation of the metabolic impact of carob-enriched pasta on postprandial glycemia.
Study 2:
This controlled, crossover study is designed to assess the postprandial glycemic response to carob flour-enriched pasta in individuals with type 1 diabetes using continuous glucose monitoring (CGM). Conducted over a 12-month period, the study involves alternating consumption of carob-enriched and standard durum wheat pasta. Participants will follow their usual dietary habits while maintaining consistent meal composition and daily routines during the test days. The study aims to explore the potential of carob-enriched pasta to modulate postprandial glycemia in a population with impaired glucose regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carob-Enriched Durum Wheat Pasta | Experimental | Dietary Supplement: Durum wheat pasta enriched with carob flour, Dietary Supplement: Standard durum wheat pasta, Dietary Supplement: White bread reference mealParticipants will consume 68 g of carob-enriched durum wheat pasta (231 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. |
| Durum Wheat Pasta | Sham comparator | Dietary Supplement: Durum wheat pasta enriched with carob flour, Dietary Supplement: Standard durum wheat pasta, Dietary Supplement: White bread reference mealParticipants will consume 63 g of traditional durum wheat pasta (221 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. |
| White Bread (Reference Food) | Active comparator | Dietary Supplement: Durum wheat pasta enriched with carob flour, Dietary Supplement: Standard durum wheat pasta, Dietary Supplement: White bread reference mealParticipants will consume 84 g of white bread (225 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Study 1
- Healthy male volunteers
- Age between 18 and 50 years
- Body Mass Index (BMI) between 18 and 29 kg/m²
- Study 2
Key exclusion criteria (10 listed)
- Study 1
- Diagnosis of diabetes mellitus
- Presence of any chronic-degenerative disease
- Any acute or chronic medical condition that could seriously compromise overall health
- Diagnosis of celiac disease
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 |
|---|---|---|
| Durum wheat pasta enriched with carob flourParticipants will consume 68 g of durum wheat pasta enriched with carob flour (231 kcal), providing 50 g of available carbohydrates. The pasta will be served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. | Dietary supplement | Carob-Enriched Durum Wheat Pasta, Durum Wheat Pasta, White Bread (Reference Food) |
| Standard durum wheat pastaParticipants will consume 63 g of standard durum wheat pasta (221 kcal), providing 50 g of available carbohydrates. The pasta will be served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. | Dietary supplement | Carob-Enriched Durum Wheat Pasta, Durum Wheat Pasta, White Bread (Reference Food) |
| White bread reference mealParticipants will consume 84 g of white bread (225 kcal), providing 50 g of available carbohydrates. The bread will be served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil. | Dietary supplement | Carob-Enriched Durum Wheat Pasta, Durum Wheat Pasta, White Bread (Reference Food) |
Primary outcome
Glycemic Index of Carob-Enriched Durum Wheat Pasta
Time frame: Within 2 hours after consumption of the test meal on three separate test days (each separated by at least 2 days).
The primary outcome is the determination of the glycemic index (GI) of a carob-enriched durum wheat pasta compared to white bread, used as the reference food. The glycemic response will be assessed through blood glucose concentrations measured at fasting and at 15, 30, 60, 90, and 120 minutes after consumption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Giuseppina Costabile study chair
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Durum wheat pasta enriched with carob flour, Standard durum wheat pasta and White bread reference meal in people with Glycemic and Insulinemic Response and Type 1 Diabetes (T1D), run by Federico II University at 1 site in Italy.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 May 2025. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lutgarda Bozzetto (+39 3333561105, lutgarda.bozzetto@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Index of Carob-Enriched Durum Wheat Pasta (time frame: Within 2 hours after consumption of the test meal on three separate test days (each separated by at least 2 days).). 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 29 May 2025.