Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

Healthy Clinical Trial

Official title:

Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526081
• Other study ID #: 429275-10
• Status: Completed
• Phase: N/A
• Start date: January 20, 2015
• Est. completion date: July 30, 2016

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Probe dietary intervention study in healthy young adult males to evaluate the concentration of apigenin derived metabolites in plasma and urine after single acute intakes of different apigenin-containing test materials.

Description:

Flavonoids, including the sub groups of Flavones (FO) are plant-derived compounds commonly present in the human diet. Examples of FO-containing foods and beverages are parsley, celery, and chamomile. The study described below will provide initial information of apigenin derived metabolites in humans. The investigators suggest the information that will be obtained from the outlined work will be particularly timely given increasing interest in the putative health effects of FO intake in humans.

This study consisted of two parts. The first part consisted of a probe study in which the investigators investigated the absorption and metabolism from four flavone-containing test products. The second phase investigated absorption and metabolism after the intake of a flavone-containing parsley drink.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 30, 2016
• Est. primary completion date: July 30, 2016
• 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 metabolic equivalence of task (MET) as defined by Centers for Disease Control and Prevention (CDC) and American College of Sports Medicine (ACSM) guidelines) 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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Chamomile Tea
Chamomile Tea in 300mL hot water
• Parsley based drink
3.2 g dried parsley in 300mL hot water
• Parsley Yogurt
3.2 g dried parsley in 100g plain yogurt
• Apigenin
Apigenin capsule mixed with 300mL hot water
• Parsley-based drink (II)
3.2 g dried parsley in 300mL hot water

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Mars, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flavone metabolites in plasma	Concentration of flavone metabolites in plasma	before to 6 h post test material intake
Primary	Flavone metabolites in urine	Amount of flavone metabolites excreted in urine	12 h before to 24 h post test material intake