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

NCT06659523 | Completed

• 1 other identifier: CE.ECTS/P05-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Prediabetes

Keywords

prediabetes; Food supplement; beta-cell function; IAPP; Urolithins

Outcome Measures

Primary Outcomes (3)

• Targeted metabolites - urolithins profiling

  Urine sample

  12 weeks

• pro-IAPP

  Blood sample

  12 weeks

• IAPP (Islet Amiloide Polipeptide)

  Boold sample

  12 weeks

Secondary Outcomes (1)

• Short-chain fatty acids profiling

  12 weeks

Study Arms (2)

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.

Dietary Supplement: EPS supplement intervention

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).

Dietary Supplement: Placebo

Interventions

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.

Supplement Intervention Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Menezes: lead
• Universidade Lusófona de Humanidades e Tecnologias: collaborator

Study Sites (1)

Lusofona University

Lisbon, Lisbon District, 1749-024, Portugal

Location

Related Publications (5)

• 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.

  PMID: 15823385 BACKGROUND

• 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.

  PMID: 34959837 BACKGROUND

• 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.

  PMID: 25223711 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.

  PMID: 36903363 BACKGROUND

• 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.

  PMID: 36589826 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Regina Menezes, PhD

  Lusofona University - CBIOS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, placebo-controlled study

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: October 26, 2024
• Study Start: June 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)