Exploring Unconventional Plant-Derived Metabolites for Glycemic Control: the Case of Pomegranate
Exploring Unconventional Plant-Derived Metabolites for Glycemic Control: the Case of Pomegranate
NCT ID: NCT06659523 Phase: NA Status: COMPLETED Enrollment: 60 Completion: 2024-09-30
Conditions
Prediabetes
Interventions
EPS supplement intervention, Placebo
Summary
The EXPLORER study will investigate whether supplementation with a pomegranate extract rich in ellagitannins is able to improve well-being and metabolic health in individuals without diabetes. The aim is to establish for the first time an association between the intake of ellagitanninsa and glycaemic control, the processing/aggregation of IAPP (a protein associated with diabetes), the state of the intestinal microbiota and circulating levels of urolithin B (a small bioavailable molecule resulting from the metabolism of ellagitannins).
This is a 12-week pilot study that is double-blind (neither participants nor researchers know who gets the treatment) and placebo-controlled (some people will receive a non-active substance). It will involve volunteers who do not have diabetes.
Phase 1 - Recruitment: Volunteers without diabetes, who are patients at a family health unit, will be recruited. Participants will provide informed consent and information such as sociodemographic and biochemical data.
Phase 2 - Intervention: The recruited individuals will be divided into two groups: one receiving the pomegranate extract supplement (intervention group) and the other receiving a placebo. In total, 60 participants will take part in the study.
Primary Outcome
Targeted metabolites - urolithins profiling