Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

NCT03526081 | Completed

• 1 other identifier: 429275-10
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Keywords

flavone; ADME; apigenin; parsley; chamomile; polyphenols

Outcome Measures

Primary Outcomes (2)

• Flavone metabolites in plasma

  Concentration of flavone metabolites in plasma

  before to 6 h post test material intake

• Flavone metabolites in urine

  Amount of flavone metabolites excreted in urine

  12 h before to 24 h post test material intake

Study Arms (5)

Chamomile Tea

EXPERIMENTAL

Chamomile Tea in 300mL hot water

Other: Chamomile Tea

Parsley based drink

EXPERIMENTAL

3.2 g dried parsley in 300mL hot water

Other: Parsley based drink

Parsley Yogurt

EXPERIMENTAL

3.2 g dried parsley in 100g plain yogurt

Other: Parsley Yogurt

Apigenin

EXPERIMENTAL

Apigenin capsule mixed with 300mL hot water

Other: Apigenin

Parsley-based drink (II)

EXPERIMENTAL

3.2 g of dried parsley in 300 ml of hot water

Other: Parsley-based drink (II)

Interventions

Chamomile Tea OTHER

Chamomile Tea in 300mL hot water

Chamomile Tea

Parsley based drink OTHER

3.2 g dried parsley in 300mL hot water

Parsley based drink

Parsley Yogurt OTHER

3.2 g dried parsley in 100g plain yogurt

Parsley Yogurt

Apigenin OTHER

Apigenin capsule mixed with 300mL hot water

Apigenin

Parsley-based drink (II) OTHER

3.2 g dried parsley in 300mL hot water

Parsley-based drink (II)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Mars, Inc.: collaborator

Study Sites (2)

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis

Davis, California, 95616, United States

Location

UC Davis

Davis, California, 95616, United States

Location

Related Publications (6)

• 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.

  PMID: 20854838 BACKGROUND

• 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.

  PMID: 22240152 BACKGROUND

• 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. doi: 10.1016/0006-2952(81)90584-0. No abstract available.

  PMID: 6946775 BACKGROUND

• 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. doi: 10.1097/00005344-200606001-00003.

  PMID: 16794446 BACKGROUND

• Heiss C, Kleinbongard P, Dejam A, Perre 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. doi: 10.1016/j.jacc.2005.06.055.

  PMID: 16198843 BACKGROUND

• Borges G, Fong RY, Ensunsa JL, Kimball J, Medici V, Ottaviani JI, Crozier A. Absorption, distribution, metabolism and excretion of apigenin and its glycosides in healthy male adults. Free Radic Biol Med. 2022 May 20;185:90-96. doi: 10.1016/j.freeradbiomed.2022.04.007. Epub 2022 Apr 20.

  PMID: 35452808 DERIVED

MeSH Terms

Interventions

Chamomile extract; Apigenin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Carl L Keen, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

• Javier I Ottaviani, PhD

  Mars, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator doing data analysis and statistical analyses
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over dietary intervention study in healthy young adult males

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: January 20, 2015
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)