Healthy
Conditions
Keywords
flavone, ADME, apigenin, parsley, chamomile, polyphenols
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.
Interventions
OTHERChamomile Tea
Chamomile Tea in 300mL hot water
OTHERParsley based drink
3.2 g dried parsley in 300mL hot water
OTHERParsley Yogurt
3.2 g dried parsley in 100g plain yogurt
OTHERApigenin
Apigenin capsule mixed with 300mL hot water
OTHERParsley-based drink (II)
3.2 g dried parsley in 300mL hot water
Sponsors
Mars, Inc.
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Masking description
Investigator doing data analysis and statistical analyses
Intervention model description
Cross-over dietary intervention study in healthy young adult males
Eligibility
Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed