Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People
Launched by FEDERICO II UNIVERSITY · May 20, 2025
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how pasta made with carob flour affects blood sugar levels in both healthy individuals and those with type 1 diabetes. Carob is a nutritious fruit often used in Mediterranean cooking, and its flour may help manage blood sugar better than regular pasta. The research consists of two parts: one study will look at healthy volunteers to see how carob-enriched pasta compares to white bread, while the other will evaluate the same pasta in people with type 1 diabetes to see how it affects their blood sugar after eating.
To participate, healthy male volunteers need to be between 18 and 50 years old and have a body mass index (BMI) between 18 and 29. For the second study, both men and women aged 18 and older with a confirmed diagnosis of type 1 diabetes who use a continuous glucose monitoring system can enroll. Participants can expect to try the carob-enriched pasta and have their blood sugar levels monitored after eating. This study aims to provide valuable insights into how carob flour can influence blood sugar control, which could be helpful for managing diets in people with diabetes.
Gender
MALE
Eligibility criteria
- 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
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Napoli, , Italy
Patients applied
Trial Officials
Giuseppina Costabile
Study Chair
Federico II University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported