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

NCT06659523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Universidade Lusófona de Humanidades e Tecnologias

    collaborator UNKNOWN

  • Regina Menezes

    lead OTHER

Principal Investigators

  • Regina Menezes, PhD · Lusofona University - CBIOS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-08-30
Completion
2024-09-30

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659523 on ClinicalTrials.gov