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Completed

NCT Number: NCT03526081

Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

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.

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Key information

Conditions

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chamomile Tea

Other

Chamomile Tea in 300mL hot water

Parsley based drink

Other

3.2 g dried parsley in 300mL hot water

Parsley Yogurt

Other

3.2 g dried parsley in 100g plain yogurt

apigenin

Other

Apigenin capsule mixed with 300mL hot water

Parsley-based drink (II)

Other

3.2 g dried parsley in 300mL hot water

Primary outcomes

  1. Flavone metabolites in plasma

    Time frame: before to 6 h post test material intake

    Concentration of flavone metabolites in plasma

  2. Flavone metabolites in urine

    Time frame: 12 h before to 24 h post test material intake

    Amount of flavone metabolites excreted in urine

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Mars, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 16, 2018
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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