Healthy Clinical Trial
Official title:
Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes
NCT number | NCT03526094 |
Other study ID # | 429275-D |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2016 |
Est. completion date | February 9, 2018 |
Verified date | October 2022 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 9, 2018 |
Est. primary completion date | February 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 60 Years |
Eligibility | 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 - History of Raynaud's disease - History of difficult blood draws - Indications of substance or alcohol abuse within the last 3 years - Current use of herbal, plant or botanical supplements (multi-vitamin/mineral supplements are allowed) - Blood Pressure > 140/90 mm Hg - GI tract disorders, previous GI surgery (except appendectomy) - Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas) - Diarrhea within the last 3 months, or antibiotic intake within the last 3 months - Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individuals following diets with significant deviations from the average diet - Metabolic panel and cholesterol results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician - Cold, flu, or upper respiratory condition at screening - Currently participating in a clinical or dietary intervention study |
Country | Name | City | State |
---|---|---|---|
United States | Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis | Davis | California |
United States | UC Davis | Davis | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Mars, Inc. |
United States,
Heiss C, Kleinbongard P, Dejam A, Perré S, Schroeter H, Sies H, Kelm M. Acute consumption of flavanol-rich cocoa and the reversal of endothelial dysfunction in smokers. J Am Coll Cardiol. 2005 Oct 4;46(7):1276-83. — View Citation
Koster H, Halsema I, Scholtens E, Knippers M, Mulder GJ. Dose-dependent shifts in the sulfation and glucuronidation of phenolic compounds in the rat in vivo and in isolated hepatocytes. The role of saturation of phenolsulfotransferase. Biochem Pharmacol. 1981 Sep 15;30(18):2569-75. — View Citation
McCullough ML, Chevaux K, Jackson L, Preston M, Martinez G, Schmitz HH, Coletti C, Campos H, Hollenberg NK. Hypertension, the Kuna, and the epidemiology of flavanols. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S103-9; discussion 119-21. — View Citation
Ottaviani JI, Momma TY, Kuhnle GK, Keen CL, Schroeter H. Structurally related (-)-epicatechin metabolites in humans: assessment using de novo chemically synthesized authentic standards. Free Radic Biol Med. 2012 Apr 15;52(8):1403-12. doi: 10.1016/j.freeradbiomed.2011.12.010. Epub 2011 Dec 23. — View Citation
Schroeter H, Heiss C, Spencer JP, Keen CL, Lupton JR, Schmitz HH. Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs. Mol Aspects Med. 2010 Dec;31(6):546-57. doi: 10.1016/j.mam.2010.09.008. Epub 2010 Sep 18. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flavanol metabolites in plasma | Plasma concentration of flavanol metabolites | Before to 6 h post test material intake | |
Secondary | Flavanol metabolites in urine | Amount of flavanols metabolites excreted in urine | 12 h before to 24 h post test material intake |
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