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Completed

NCT Number: NCT06659523

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lusofona University

Lisbon, Lisbon District, 1749-024, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals without diabetes
  • Both sexes
  • Aged between 18 and 65
  • Body Mass Index (BMI) less than 29.9 kg/m2
  • Fasting plasma glucose levels below 126 mg/dL
  • Haemoglobin A1C levels between 5.7 - 6.5%

Exclusion criteria

  • Not agreeing to take part in the study
  • BMI>30 kg/m2
  • Being diagnosed with diabetes
  • Having any type of cognitive disorder
  • Using anti-diabetic medication
  • Alcohol or drug abuse
  • Pomegranate allergy
  • Regular use of food supplements
  • Difficulty swallowing tablets
  • Being on, or planning to be on during the study period, a different diet than usual
  • Pregnancy, planning to become pregnant during the study, breastfeeding 1 year before or during the study
  • Oncological, cardiac, hepatic, renal, thyroid or other endocrine diseases
  • Medical or social conditions that may affect adherence
  • Participating in another study at the same time.

Treatment and study plan

EPS supplement intervention

Dietary Supplement

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.

Placebo

Dietary Supplement

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.

Primary outcomes

  1. Targeted metabolites - urolithins profiling

    Time frame: 12 weeks

    Urine sample

  2. pro-IAPP

    Time frame: 12 weeks

    Blood sample

  3. IAPP (Islet Amiloide Polipeptide)

    Time frame: 12 weeks

    Boold sample

Secondary outcomes

  1. Short-chain fatty acids profiling

    Time frame: 12 weeks

    Blood sample

Sponsors and collaborators

Lead sponsor

Regina Menezes

Other

Collaborators

  • Universidade Lusófona de Humanidades e Tecnologias

Registry information

Acronym: EXPLORER

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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