Differential Absorption Kinetics of Grape Seed Extract Polyphenols

NCT07886385 | Not Yet Recruiting

• 1 other identifier: IRB2027_0062
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Grape seed extracts (GSEs) contain (poly)phenols that vary in their degree of polymerization, which may lead to differences in absorption, metabolism, and biological efficacy. This pilot study will evaluate how GSEs with varying degrees of polymerization are absorbed, cleared, and metabolized in healthy adults. Two separate pilot studies will be conducted. Study 1 will evaluate MN-BP compared to another commercially available GSE. Study 2 will evaluate four next-generation (Gen 2) GSE preparations enriched in monomers, oligomers, polymers, or a mixture. Blood and urine samples will be collected at multiple time points following GSE consumption to assess bioavailability and metabolic profiles of the different GSE preparations.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of GSE-derived (poly)phenols and their metabolites

  Plasma concentrations of parent GSE-derived (poly)phenolic compounds and their metabolites will be measured using ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS) at different time points following each GSE intervention.

  Baseline through 24 hours after GSE consumption

• Urinary concentrations of GSE-derived (poly)phenols and their metabolites

  Urine samples will be analyzed using ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS) to quantify GSE-derived (poly)phenolic compounds and their metabolites following each GSE intervention

  Baseline through 24 hours after GSE consumption

Secondary Outcomes (3)

• Bioavailability of GSE-derived (poly)phenols and their metabolites

  Baseline through 24 hours after GSE consumption

• Plasma metabolite profiles following GSE consumption

  Baseline through 24 hours after each GSE intervention

• Urinary metabolite profiles following GSE consumption

  Baseline through 24 hours after each GSE intervention

Study Arms (2)

Study 1 - MN-BP and Commercially Available GSE

EXPERIMENTAL

Participants in Study 1 will receive MN-BP and another commercially available grape seed extract (GSE) during separate intervention periods in a randomized, double-blinded, crossover design. GSEs will be administered in capsule form.

Dietary Supplement: MN-BP Grape Seed Extract; Dietary Supplement: Commercially Available Grape Seed Extract

Study 2 - Gen 2 GSE Preparations

EXPERIMENTAL

Participants in Study 2 will receive next-generation (Gen 2) grape seed extract (GSE) preparations enriched in monomers, oligomers, polymers, or a mixture during separate intervention periods in a randomized, double-blinded, crossover design

Dietary Supplement: Gen 2 GSE - Monomer-Enriched; Dietary Supplement: Gen 2 GSE - Oligomer-Enriched; Dietary Supplement: Gen 2 GSE - Polymer-Enriched; Dietary Supplement: Gen 2 GSE - Mixture

Interventions

Commercially Available Grape Seed Extract DIETARY_SUPPLEMENT

Study 1 - MN-BP and Commercially Available GSE

Study 1 - MN-BP and Commercially Available GSE

Gen 2 GSE - Oligomer-Enriched DIETARY_SUPPLEMENT

Study 2 - Gen 2 GSE Preparations

Study 2 - Gen 2 GSE Preparations

MN-BP Grape Seed Extract DIETARY_SUPPLEMENT

Study 1 - MN-BP and Commercially Available GSE

Study 1 - MN-BP and Commercially Available GSE

Gen 2 GSE - Monomer-Enriched DIETARY_SUPPLEMENT

Study 2 - Gen 2 GSE Preparations

Study 2 - Gen 2 GSE Preparations

Gen 2 GSE - Polymer-Enriched DIETARY_SUPPLEMENT

Study 2 - Gen 2 GSE Preparations

Study 2 - Gen 2 GSE Preparations

Gen 2 GSE - Mixture DIETARY_SUPPLEMENT

Study 2 - Gen 2 GSE Preparations

Study 2 - Gen 2 GSE Preparations

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women, 18-45 years of age
• Willing to maintain their usual dietary habits with low (poly)phenol intake and physical activity patterns 3 days before the study visits. Willing and able to comply with all study requirements, including:
• Consumption of standardized low-(poly)phenol meals and study treatments.
• Completion of all scheduled clinic visits and biological sample collections.
• Compliance with dietary restrictions and study instructions.
• Able to provide informed consent
• Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study; able to come to the clinic up to 5 times during the study
• Able to maintain usual physical activity pattern
• Able to avoid/abstain from alcohol/and vigorous physical activity for 24 hours prior to and during the study visit

You may not qualify if:

• Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions
• Fasting blood sugar \>125 mg/dL
• Men and women with blood pressure \>160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit
• Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year
• Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years
• Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints
• Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.)
• Men and women who are not weight stable (+/-10lbs in previous 2 months)
• Men and women who have excessive use of drugs or alcohol (i.e.., addictions) within the past 2 years
• Men and women with documented physical or mental disease/condition, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study
• Women who are lactating
• Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI.
• Has used antibiotics within the previous 2 months
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman

  708-563-8276

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indika Edirisinghe

CONTACT

708-563-8178; iedirisi@illinoistech.edu

Chelsesa Preiss

CONTACT

303-567-5308; cpreiss@illinoistech.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded to the assigned GSE intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two separate randomized, double-blinded, crossover pilot studies will evaluate the absorption and clearance kinetics and metabolite profiles of GSEs with varying degrees of polymerization in healthy adults. Study 1 will compare MN-BP with another commercially available GSE. Study 2 will evaluate next-generation (Gen 2) GSE preparations enriched in monomers, oligomers, polymers, or a mixture.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 21, 2026
• Study Start: October 20, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)