Effects of Carob-Enriched Pasta on Blood Sugar Levels in Healthy Individuals and Those with Type 1 Diabetes
Evaluation of the Glycemic Response to a Pasta Enriched With Carob Flour: a Study Conducted in Healthy Subjects and a Study Conducted in Subjects With Type 1 Diabetes Mellitus
This study is testing if eating pasta made with carob flour can help control blood sugar levels in both healthy people and those with type 1 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06994403 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the glycemic response to durum wheat pasta enriched with carob flour in both healthy adults and individuals with type 1 diabetes. The study employs a randomized, controlled, crossover design, where participants will consume carob-enriched pasta and standard pasta under controlled conditions. The glycemic response will be measured using continuous glucose monitoring in participants with type 1 diabetes, comparing the effects of the enriched pasta to a reference food, white bread. The goal is to evaluate the potential of carob flour to improve postprandial glycemia and overall metabolic health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of type 1 diabetes or healthy males aged 18 to 50 with a BMI between 18 and 29.
Not a fit: Patients with serious chronic illnesses, gastrointestinal disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary option that helps manage blood sugar levels in individuals with type 1 diabetes.
How similar studies have performed: Previous studies have shown promising results with similar dietary interventions, suggesting potential benefits of carob in glycemic control.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Naples
- Federico II University — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Lutgarda Bozzetto
- Email: lutgarda.bozzetto@unina.it
- Phone: +39 3333561105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.