Comparison of the Bioavailability of the Flavanol of Grape Extracts

NCT06665958 | Enrolling By Invitation

• 1 other identifier: REC/24/0047
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Polyphenols are a group of naturally occurring compounds found in cocoa, teas, and grape seed extracts (GSE) that have been linked to various health benefits. This study will provide a greater insight into the relationship between polyphenol consumption and health, and could be used to help with the development of functional food products and novel supplements. Although the advantages of a polyphenol-rich diet are well-established, the bioavailability of GSE (a source of polyphenols) in the context of human digestion and beneficial properties are poorly understood. The investigators will conduct an open-label, randomized, 4-way crossover design with the aim to explore the bioavailability of GSE-derived flavan-3-ols from GSE and their related microbial metabolites and advance understanding of the bioactive properties of flavan-3-ols contributing to the development of more effective dietary strategies and functional food products.

Conditions

Healthy Nutrition

Keywords

Flavan-3-ols, grape seed extracts; microbial metabolites; bioavailability; Flavan-3-ols; grape seed extracts

Outcome Measures

Primary Outcomes (1)

• Plasma concentration (µM) of flavan-3-ols monomer (poly)phenols.

  Quantification by LC-MS/MS

  Change over 24 hours compared across treatments

Secondary Outcomes (4)

• Plasma concentration (µM) of main flavan-3-ol metabolites.

  Change over 24 hours compared across treatments

• Total excretion of primary flavanol metabolites (µM).

  Change over 24 hours compared across treatments.

• Systolic Blood Pressure (mmHg)

  Measured at 8 hours post-ingestion compared across treatments.

• Diastolic Blood Pressure (mmHg)

  Measured at 8 hours post-ingestion compared across treatments.

Other Outcomes (1)

• Tolerance/Acceptability Questionnaire

  Measured at 8 hours post-ingestion compared across treatments.

Study Arms (4)

Experimental: Polyphenol extract low dose (hard capsule)

EXPERIMENTAL

\<2% flavanol monomer hard capsule

Dietary Supplement: Polyphenol extract

Experimental: Polyphenol extract medium dose (hard capsule)

EXPERIMENTAL

15% flavanol monomer hard capsule

Dietary Supplement: Polyphenol extract

Experimental: Polyphenol extract medium dose (gummy)

EXPERIMENTAL

15% flavanol monomer x2 gummy

Dietary Supplement: Polyphenol extract

Experimental: Polyphenol extract high dose (hard capsule)

EXPERIMENTAL

26% flavanol monomer hard capsule

Dietary Supplement: Polyphenol extract

Interventions

Polyphenol extract DIETARY_SUPPLEMENT

Single dose

Experimental: Polyphenol extract high dose (hard capsule); Experimental: Polyphenol extract low dose (hard capsule); Experimental: Polyphenol extract medium dose (gummy); Experimental: Polyphenol extract medium dose (hard capsule)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Biological males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males
• Aged 18-40 years at recruitment
• BMI ≥ 20 and \< 30kg/m2
• Considered healthy based on their medical history and physical examination.
• Subjects capable of and willing to comply with the protocol and to give their written informed consent.

You may not qualify if:

• Existing chronic disease including any; cardiovascular, neurological, gastric/intestinal, hepatic/pancreatic, renal or hematological diseases, obstructive cardiomyopathy, myocardial infarction, intracranial hypertension, diabetes mellitus (type I or II), chronic kidney disease, clinically significant arrhythmia, metabolic anomaly, ischaemia heart disease.
• Uncontrolled Hypertension (\>160/100 mm Hg) or hypotension (\<100/60mm Hg)
• Current use of any medication or narcotics within 2 weeks prior to study entry.
• Currently on a clinically prescribed diet regimen.
• Self-reported alcohol intake of \>10 units/ week
• Have taken antibiotic therapy within the last 3 months
• Following any specific diet (vegetarian, vegan, etc.)
• Consumption of dietary supplement(s) currently or within 4 weeks prior to study entry (i.e. botanicals, vitamins, minerals, amino acids).
• Weight change \> 10% of total body weight within the 6 months before entry to study.
• Any intolerance or allergy documented or suspected to one of the components of the study products.
• Having a psychological or linguistic inability to sign the informed consent; Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
• Subject participating in another biomedical study or participation in another study within the 3 months before entry into this study.

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Ulster University,Human Intervention Studies UnitColeraine, Co. Londonderry BT521SA

Coleraine, Co. Londonderry, BT52 1SA, United Kingdom

Location

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chris Gill

  Ulster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 30, 2024
• Study Start: October 28, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)