Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

Study Overview
=================
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.

Official Title
-----------------
Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Chamomile Tea
* Other: Parsley based drink
* Other: Parsley Yogurt
* Other: Apigenin
* Other: Parsley-based drink (II)


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over dietary intervention study in healthy young adult males
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chamomile Tea<br>Chamomile Tea in 300mL hot water | Other: Chamomile Tea<br>* Chamomile Tea in 300mL hot water<br>|
| Experimental: Parsley based drink<br>3.2 g dried parsley in 300mL hot water | Other: Parsley based drink<br>* 3.2 g dried parsley in 300mL hot water<br>|
| Experimental: Parsley Yogurt<br>3.2 g dried parsley in 100g plain yogurt | Other: Parsley Yogurt<br>* 3.2 g dried parsley in 100g plain yogurt<br>|
| Experimental: Apigenin<br>Apigenin capsule mixed with 300mL hot water | Other: Apigenin<br>* Apigenin capsule mixed with 300mL hot water<br>|
| Experimental: Parsley-based drink (II)<br>3.2 g of dried parsley in 300 ml of hot water | Other: Parsley-based drink (II)<br>* 3.2 g dried parsley in 300mL hot water<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flavone, chamomile, polyphenols, ADME, apigenin, parsley