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

Regina Menezes

Status: Completed

Conditions: Prediabetes

Treatments: Dietary Supplement: EPS supplement intervention; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06659523

CE.ECTS/P05-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Supplement Intervention Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: EPS supplement intervention

Placebo Group

Placebo Comparator group

Description:

29 individuals with pre-diabetes, 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 placebo supplement (cellulose).

Treatment:

Dietary Supplement: Placebo