Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People
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, s
| Condition(s) | Glycemic and Insulinemic Response, Type 1 Diabetes (T1D) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 impac |
| Who can participate | Inclusion Criteria: 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 Exclusion Criteria: 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 |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Federico II University |
| Locations | Naples, Italy |
| Start date | 2023-09-04 |
| NCT ID | NCT06994403 |
| Official listing | https://clinicaltrials.gov/study/NCT06994403 |