NCT06659523

Exploring Unconventional Plant-Derived Metabolites for Glycemic Control: the Case of Pomegranate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Regina Menezes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

A double-blinded, randomized, placebo-controlled pilot study was designed to assess the effect of Ellagitannins Pomegranate Supplements (EPS) in metabolic health of participants. Participants will be recruited at the family health unit USF São Martinho de Alcabideche from the grouping of health centres ACES Cascais, and the study will be conducted according to universal bioethical principles. At least 60 individuals with pre-diabetes will be included in the study. After the fulfilment of the inclusion criteria, they will be randomly assigned to the intervention group (IG) and the placebo group (PG). Equal distribution of gender, age and BMI will be ensured between the groups.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EPS supplement intervention	31 healthy individuals, male and female, were recruted at one family health unit, and randomly assigned to the intervention group, and were given for 12 weeks of one daily dose of 1.5 g powdered capsules of EPS.
DIETARY_SUPPLEMENT	Placebo	29 healthy individuals, male and female, were recruted at one family health unit, and randomly assigned to the placebo group, and were given for 12 weeks of one daily dose of placebo.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-08-30
• Completion: 2024-09-30
• First posted: 2024-10-26
• Last updated: 2024-10-29

Locations

1 site across 1 country: Portugal