Status:
RECRUITING
Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People
Lead Sponsor:
Federico II University
Conditions:
Glycemic and Insulinemic Response
Type 1 Diabetes (T1D)
Eligibility:
MALE
18-50 years
Phase:
NA
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...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06994403
Start Date
September 4 2023
End Date
December 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
Federico II University
Napoli, Italy, 80131