Starting soon
Not applicable
Differential Absorption Kinetics of Grape Seed Extract Polyphenols
Condition(s) studied
Healthy Adults
Investigational drug(s) / intervention(s)
MN-BP Grape Seed ExtractCommercially Available Grape Seed ExtractGen 2 GSE - Monomer-EnrichedGen 2 GSE - Oligomer-EnrichedGen 2 GSE - Polymer-EnrichedGen 2 GSE - Mixture
MN-BP Grape Seed Extract: Study 1 - MN-BP and Commercially Available GSE
Commercially Available Grape Seed Extract: Study 1 - MN-BP and Commercially Available GSE
Gen 2 GSE - Monomer-Enriched: Study 2 - Gen 2 GSE Preparations
Gen 2 GSE - Oligomer-Enriched: Study 2 - Gen 2 GSE Preparations
Gen 2 GSE - Polymer-Enriched: Study 2 - Gen 2 GSE Preparations
Gen 2 GSE - Mixture: Study 2 - Gen 2 GSE Preparations
Study 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.
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Excessive coffee and tea consumers (\> 4 cups/d)
* Donated blood within the last 3 months
* Women who are taking an unstable dose and brand of hormonal contraceptives and/or a stable dose and brand for less than 6 months
* Unusual working hours i.e., working overnight (e.g., 3rd shift)
* Participant who is a current smoker and unable to be smoke-free for 24 h.
Primary outcome measure(s)
- Plasma concentrations of GSE-derived (poly)phenols and their metabolites — Baseline through 24 hours after GSE consumption
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.
- Urinary concentrations of GSE-derived (poly)phenols and their metabolites — Baseline through 24 hours after GSE consumption
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
Trial sites (1)
| Facility | City | Region | Status |
| Clinical Nutrition Research Center |
Chicago |
Illinois |
|
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