RecruitingNot ApplicableNCT06888167

Food (Poly)Phenol Metabotypes and Beta-cell Mass and Function.

Experimental, Drug-free, Cross-sectional, Single-centre Study to Assess the Association Between Metabotypes of Dietary (Poly)Phenols and Beta-cell Mass and Function.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Enrollment

40 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer

Summary

Cross-sectional, single-centre, 'low intervention' clinical study, without drug or medical device testing, with low-risk diagnostic technique.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Having been enrolled in the OPCT study;
Ability to understand the methods, purposes and implications of the study, and to give free and informed consent.

Exclusion Criteria7

Pregnancy or breastfeeding;
Previous exposure to ionizing radiation in research programs;
History of psychiatric illness or alcohol abuse;
Head trauma;
Active neurological disease;
Claustrophobia;
Active malignant neoplastic disease.

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Interventions

OTHERStudy setting

The subjects in the study will undergo two days of visits, in random order. 1. Following a fasting period of at least 4 hours, the study participants will undergo a PET-CT examination with Ga-exadin-4. Fasting will reduce the endogenous secretion of GLP-1 by the small intestine, which can otherwise compete with exendin-4 for binding to GLP-1R. Blood glucose will be measured before the injection of the tracer and monitored at each time point. 2. On a fasting basis, the anthropometric data of the enrolled subjects will be collected and they will undergo a short interview on their lifestyle. Subsequently, at time 0, the subjects will ingest a standard mixed meal consisting of 2 commercially available "ABC Parmareggio" snacks. Venous blood samples will be taken at specific time intervals (from -20 to 300 minutes) to measure glucose, C-peptide, insulin, glucagon, GLP-1 and glucose-dependent insulinotropic (GIP) curves. An additional blood sample will be taken at time -10 in order to isolate