NCT03526107

Food Matrix Effect on Flavanol Absorption, Metabolism and Excretion: Methylxanthines

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	CF Control	CF Control: 587 mg of cocoa flavanols, \<1 mg caffeine and \<1 mg theobromine
OTHER	CF-Theobromine	CF-Theobromine: 575 mg of cocoa flavanols, 11 mg caffeine and 93 mg theobromine
OTHER	CF-Caffeine	CF-Caffeine: 587 mg of cocoa flavanols, 112 mg caffeine and \<1 mg theobromine

Timeline

• Start date: 2017-02-16
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2018-05-16
• Last updated: 2022-10-10

Locations

2 sites across 1 country: United States