NCT06028659 Investigation of in Vivo Endogenous and/or Exogenous Production of Phenolic Metabolites Using (un)Targeted Metabolomics
| NCT ID | NCT06028659 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Parma |
| Condition | Individual Variability in (Poly)Phenol Metabolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-10-25 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Plant (poly)phenols is what we call a large number of substances that are produced by plants as secondary plant metabolites, which means substances that are not used for their growth and development but are necessary for them to survive. (Poly)phenols are divided in two major groups, flavonoids, and non-flavonoids, and each group contains a varied set of subgroups and substances. They are widely spread in fruit and vegetables that are part of the human diet, and, in general, studies have attributed many biological effects to the ingestion of (poly)phenols, especially in the prevention of non-communicable diseases. For this reason, research aims to understand their role in the health benefits of a diet that is rich in fruits and vegetables. When ingested, (poly)phenols are digested by both the human organism and the gut microbiota and are broken down into several smaller substances (catabolites) that are called low-molecular weight (poly)phenols (LMWP). Most of the absorbed (poly)phenols that reach our bloodstream and organs are LMWP. For the proposed study, 30 healthy adults will be recruited and, if considered able to participate, will follow a standardized diet that is restricted in (poly)phenol intake and will be randomly divided into two groups: one will receive a known source of (poly)phenols (coffee) and the other will receive water, keeping the restriction of (poly)phenol from the diet. The duration of one phase is 4 days + 12 hours, during which urine, feces, and saliva will be collected. Then, after a 2-week-interval, subjects will repeat the experiment, except that this time the group who had coffee will have water, and vice versa. Again, urine and feces will be collected. The objective of the study is to identify and quantify LMWP mainly in urine, but also in feces, and try to understand how much was produced when there was no (poly)phenols in the diet compared with when there was ingestion of coffee (poly)phenols. The production of LMWP without coffee could be because of their production from other sources, like the metabolism of amino acids, proteins, and catecholamines (i.e. dopamine). The composition of the gut microbiota and relevant genetic information can alter the metabolism of (poly)phenols and will be considered in the analyses. Knowing how much of LMWP actually comes from the diet is important to understand the relevance and health benefits of these molecules.
Eligibility Criteria
Inclusion Criteria: * Apparently healthy adults, * Age 20-40 years old, * Body mass index (BMI) between 18-28, * Regular coffee consumers (at least 1 cup a day). Exclusion Criteria: * Clinical diagnosis of metabolic diseases, * Clinical diagnosis of cardiovascular diseases, * Clinical diagnosis of renal diseases, * Clinical diagnosis of digestive diseases, * Immunodeficiency * Autoimmune diseases (other than well-compensated hypothyroidism), * Mental disorders * Regular use of medication (except birth-control pills and hormone replacement therapies), * Use of antibiotics in the last month prior to enrollment, * Food allergies or intolerances, * Pregnancy * Lactation
Contact & Investigator
Pedro M Mena Parreño, PhD
PRINCIPAL INVESTIGATOR
University of Parma
Frequently Asked Questions
Who can join the NCT06028659 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 40 Years, studying Individual Variability in (Poly)Phenol Metabolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06028659 currently recruiting?
Yes, NCT06028659 is actively recruiting participants. Contact the research team at pedromiguel.menaparreno@unipr.it for enrollment information.
Where is the NCT06028659 trial being conducted?
This trial is being conducted at Parma, Italy.
Who is sponsoring the NCT06028659 clinical trial?
NCT06028659 is sponsored by University of Parma. The principal investigator is Pedro M Mena Parreño, PhD at University of Parma. The trial plans to enroll 30 participants.