Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Parsley based drink; Other: Apigenin; Other: Chamomile Tea; Other: Parsley Yogurt; Other: Parsley-based drink (II)

• Registration Number: NCT03526081
• Lead Sponsor: University of California, Davis

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.

Detailed 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.

Study Timeline

• Study Start: 2015-01-20
• Primary Completion: 2016-07-30
• Study Completion: 2016-07-30
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Parsley based drink	Parsley based drink	3.2 g dried parsley in 300mL hot water
Apigenin	Apigenin	Apigenin capsule mixed with 300mL hot water
Chamomile Tea	Chamomile Tea	Chamomile Tea in 300mL hot water
Parsley Yogurt	Parsley Yogurt	3.2 g dried parsley in 100g plain yogurt
Parsley-based drink (II)	Parsley-based drink (II)	3.2 g of dried parsley in 300 ml of hot water

Primary Outcome Measures

Name	Time	Method
Flavone metabolites in plasma	before to 6 h post test material intake	Concentration of flavone metabolites in plasma
Flavone metabolites in urine	12 h before to 24 h post test material intake	Amount of flavone metabolites excreted in urine

Trial Locations

Locations (2)

UC Davis; 🇺🇸 Davis, California, United States

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis; 🇺🇸 Davis, California, United States