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

NCT06994403 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-29

No results posted yet for this study

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)

Interventions

DIETARY_SUPPLEMENT

Durum wheat pasta enriched with carob flour

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.

DIETARY_SUPPLEMENT

Standard durum wheat pasta

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.

DIETARY_SUPPLEMENT

White bread reference meal

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.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Giuseppina Costabile · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994403 on ClinicalTrials.gov