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Clinical Trials/NCT03526094
NCT03526094
Completed
Not Applicable

Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes

University of California, Davis2 sites in 1 country23 target enrollmentMay 5, 2016
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of California, Davis
Enrollment
23
Locations
2
Primary Endpoint
Flavanol metabolites in plasma
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Dietary intervention study in healthy adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of flavanols from different fruit-based drinks.

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 we 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. This study consisted of two parts. One part investigated flavanols absorption and metabolism from different fruit-based drinks and other food matrixes. The second part investigated flavanol absorption and metabolism after the intake of a flavanol drink alone and simultaneously consumed with a banana-based drink. 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.

Registry
clinicaltrials.gov
Start Date
May 5, 2016
End Date
February 9, 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

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 plasma

Time Frame: Before to 6 h post test material intake

Plasma concentration of flavanol metabolites

Secondary Outcomes

  • Flavanol metabolites in urine(12 h before to 24 h post test material intake)

Study Sites (2)

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