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| Name | Class |
|---|---|
| Universidade Lusófona de Humanidades e Tecnologias | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement Intervention Group | Experimental | 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. |
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| Placebo Group | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Targeted metabolites - urolithins profiling | Urine sample | 12 weeks |
| pro-IAPP | Blood sample | 12 weeks |
| IAPP (Islet Amiloide Polipeptide) | Boold sample | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short-chain fatty acids profiling | Blood sample | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regina Menezes, PhD | Lusofona University - CBIOS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lusofona University | Lisbon | Lisbon District | 1749-024 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36903363 | Background | Mansoor K, Bardees R, Alkhawaja B, Mallah E, AbuQatouseh L, Schmidt M, Matalka K. Impact of Pomegranate Juice on the Pharmacokinetics of CYP3A4- and CYP2C9-Mediated Drugs Metabolism: A Preclinical and Clinical Review. Molecules. 2023 Feb 24;28(5):2117. doi: 10.3390/molecules28052117. | |
| 36589826 | Background |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Double-blind, placebo-controlled study
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| 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. |
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| Raimundo AF, Ferreira S, Pobre V, Lopes-da-Silva M, Brito JA, Dos Santos DJVA, Saraiva N, Dos Santos CN, Menezes R. Urolithin B: Two-way attack on IAPP proteotoxicity with implications for diabetes. Front Endocrinol (Lausanne). 2022 Dec 15;13:1008418. doi: 10.3389/fendo.2022.1008418. eCollection 2022. |
| 15823385 | Result | Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. doi: 10.1016/S0140-6736(05)61032-X. |
| 34959837 | Result | Raimundo AF, Ferreira S, Tomas-Barberan FA, Santos CN, Menezes R. Urolithins: Diet-Derived Bioavailable Metabolites to Tackle Diabetes. Nutrients. 2021 Nov 27;13(12):4285. doi: 10.3390/nu13124285. |
| 25223711 | Result | Banihani SA, Makahleh SM, El-Akawi Z, Al-Fashtaki RA, Khabour OF, Gharibeh MY, Saadah NA, Al-Hashimi FH, Al-Khasieb NJ. Fresh pomegranate juice ameliorates insulin resistance, enhances beta-cell function, and decreases fasting serum glucose in type 2 diabetic patients. Nutr Res. 2014 Oct;34(10):862-7. doi: 10.1016/j.nutres.2014.08.003. Epub 2014 Aug 20. |
| D004700 | Endocrine System Diseases |