Effects of Carob-Enriched Pasta on Blood Sugar Levels in Healthy Individuals and Those with Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Federico II University
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Lutgarda Bozzetto
• Email: lutgarda.bozzetto@unina.it
• Phone: +39 3333561105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.