Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People

NCT06994403 | Recruiting

• 1 other identifier: 32/2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Glycemic and Insulinemic Response; Type 1 Diabetes (T1D)

Keywords

Ceratonia siliqua; Glycemic Index; Type 1 Diabetes; Functional Foods; Postprandial Glycemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 2 hours after consumption of the test meal on three separate test days (each separated by at least 2 days).

Other Outcomes (1)

• Postprandial Glycemic Response (iAUC) to Carob-Enriched Pasta in Type 1 Diabetes

  6 hours post-meal on 6 different test days over a 2-week period.

Study Arms (3)

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.

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.

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.

Dietary Supplement: Durum wheat pasta enriched with carob flour; Dietary Supplement: Standard durum wheat pasta; Dietary Supplement: White bread reference meal

Interventions

Durum wheat pasta enriched with carob flour DIETARY_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.

Carob-Enriched Durum Wheat Pasta; Durum Wheat Pasta; White Bread (Reference Food)

Standard durum wheat pasta DIETARY_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.

Carob-Enriched Durum Wheat Pasta; Durum Wheat Pasta; White Bread (Reference Food)

White bread reference meal DIETARY_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.

Carob-Enriched Durum Wheat Pasta; Durum Wheat Pasta; White Bread (Reference Food)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age ≥ 18 years
• Confirmed diagnosis of type 1 diabetes mellitus
• Use of a continuous glucose monitoring (CGM) system

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

locust bean gum

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Giuseppina Costabile

  Federico II University

  STUDY CHAIR

Central Study Contacts

Lutgarda Bozzetto

CONTACT

+39 3333561105; lutgarda.bozzetto@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: September 4, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)