Food (Poly)Phenol Metabotypes and Beta-cell Mass and Function.
ConditionHealthy Volunteer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Parma
About this trial
Cross-sectional, single-centre, 'low intervention' clinical study, without drug or medical device testing, with low-risk diagnostic technique.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy or breastfeeding;
Previous exposure to ionizing radiation in research programs;
History of psychiatric illness or alcohol abuse;
Head trauma;
Trial design
Design model
Parallel
Treatments tested in this trial
Study setting
Other interventionThe 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
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Participants in the OPCT study - MT 'A', low disposition index (n=10)Other 1 intervention
Group B: Participants in the OPCT study - MT 'A', high disposition index (n=10)Other 1 intervention
Group C: Participants of the OPCT study - MT 'B', low disposition index (n=10)Other 1 intervention
Group D: Participants of the OPCT study - MT 'B', high disposition index (n=10)Other 1 intervention
Trial outcomes
Primary outcomes
1
Specific metabotypes (MTs) that associate with different pancreatic beta-cell mass and function (BCFxM).
BCFxM=parametes derived from mixed meal test Beta cell function (BCF)=BCFxM/BCM
Time frame
through study completion, an average of 3 months after enrolmentSecondary outcomes
1
Pancreatic beta cell mass (BCM)
Beta cell mass index (BCM)=68GA-exendin-4-Standard Uptake Value (SUV)\*pancreatic volume
Time frame
through study completion, an average of 3 months after enrolment2
Pancreatic beta cell function (BCF)
BCFxM/BCM
Time frame
through study completion, an average of 3 months after enrolment3
Specific MTs that exhibit different beta-cell mass (BCM) in vivo.
Time frame
through study completion, an average of 3 months after enrolment4
Personalized nutritional interventions.
Lay the foundation for the design of personalized nutritional interventions that can reduce the risk of specific diseases, such as the risk of developing type 2 diabetes and the consequences of diabetes-related organ damage (including cardiovascular system) depending on one's MT.
Time frame
through study completion, an average of 3 months after enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda Ospedaliero-Universitaria di Parma
Lead sponsor
University of Parma
Collaborator
Source ClinicalTrials.gov