Food Matrix Effect on Flavanol Absorption, Metabolism and Excretion: Methylxanthines
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- University of California, Davis
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Flavanol metabolites in urine
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Dietary intervention study in healthy young adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of methylxanthines.
Detailed Description
Flavonoids, including the sub groups of Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods and beverages has been associated with improvements in cardiovascular health. In this context, there exists a great interest in describing the absorption, metabolism and excretion of F in humans, as it is thought that F-derived metabolites present in circulation are the mediators of F-beneficial effects in humans. Recently, the investigators described a series of F-derived metabolites in circulation that are present after the consumption of a single acute intake amount of F in humans as well as F-metabolites derived from the metabolic activity of the gut microbiome. A key question, however, is if the metabolites the investigators observed after a single acute feeding are the same as those that occur in individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism of numerous other xenobiotics have shown that the profile of metabolites can greatly vary over time, as well as with the amount of the xenobiotic ingested. In this context, the investigators submit it is important to assess whether or not there are food matrix-dependent effects on the levels and profile of F-derived metabolites in humans. The investigators suggest the information that will be obtained from the outlined work will be particularly timely given ongoing discussion concerning the possible generation of dietary recommendations for F-rich foods and increasing interest in the putative health effects of F intake in humans. Following the beginning of the trial, an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis https://doi.org/10.1093/jaoacint/qsaa132). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of our intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to our intervention, the total cocoa flavanol content of select arms in our trials have been updated accordingly.
Investigators
Eligibility Criteria
Inclusion Criteria
- •No prescription medications
- •BMI 18.5 - 29.9 kg/m2
- •Weight ≥ 110 pounds
- •previously consumed cocoa, peanut, parsley, celery and chamomile products with no adverse reactions
Exclusion Criteria
- •Adults unable to consent
- •Prisoners
- •Non-English speaking\*
- •BMI ≥ 30 kg/m2
- •Performing vigorous physical activity (i.e. more than 6 MET; metabolic equivalence of task as defined by CDC and ACSM guidelines (http://www.cdc.gov/physicalactivity/everyone/glossary/index.html#vig-intensity; and http://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA_Intensity_table_2_1.pdf ) for more than 3 days a week.
- •Dietary allergies including those to nuts, cocoa and chocolate products, parsley, celery and chamomile.
- •Active avoidance of coffee and caffeinated soft drinks
- •Under current medical supervision
- •A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
- •History of clinically significant depression, anxiety or other psychiatric condition
Outcomes
Primary Outcomes
Flavanol metabolites in urine
Time Frame: 12 h before to 24 h post test material intake
Amount of flavanols metabolites excreted in urine
Flavanol metabolites in plasma
Time Frame: Before to 6 h post test material intake
Plasma concentration of flavanol metabolites
Secondary Outcomes
- Methylxanthines in urine(12 h before to 24 h post test material intake)
- Methylxanthines in plasma(Before to 6 h post test material intake)