HealthyNCT03526081
Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides
A study testing Chamomile Tea, Parsley based drink and Parsley Yogurt in people with Healthy, run by University of California, Davis at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Chamomile Tea, Parsley based drink and Parsley Yogurt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jan 2015to 30 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis
Davis, California, 95616
UC Davis
Davis, California, 95616
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Chamomile Tea, Parsley based drink, Parsley Yogurt, Apigenin, Parsley-based drink (II)
- Keywords
- flavone, ADME, apigenin, parsley, chamomile, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chamomile TeaOther
Chamomile Tea in 300mL hot water
Parsley based drinkOther
3.2 g dried parsley in 300mL hot water
Parsley YogurtOther
3.2 g dried parsley in 100g plain yogurt
ApigeninOther
Apigenin capsule mixed with 300mL hot water
Parsley-based drink (II)Other
3.2 g dried parsley in 300mL hot water
| Study group | Role | What they receive |
|---|---|---|
| Chamomile Tea | Experimental | Chamomile Tea in 300mL hot water Receives: Other: Chamomile Tea |
| Parsley based drink | Experimental | 3.2 g dried parsley in 300mL hot water Receives: Other: Parsley based drink |
| Parsley Yogurt | Experimental | 3.2 g dried parsley in 100g plain yogurt Receives: Other: Parsley Yogurt |
| Apigenin | Experimental | Apigenin capsule mixed with 300mL hot water Receives: Other: Apigenin |
| Parsley-based drink (II) | Experimental | 3.2 g of dried parsley in 300 ml of hot water Receives: Other: Parsley-based drink (II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavone metabolites in plasma
Concentration of flavone metabolites in plasma
Measured: before to 6 h post test material intake
Flavone metabolites in urine
Amount of flavone metabolites excreted in urine
Measured: 12 h before to 24 h post test material intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start20 Jan 2015
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Cross-over dietary intervention study in healthy young adult males
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc.
- Responsible party
- Sponsor
- Investigators
- Carl L Keen, PhD, Principal investigator, UC DavisJavier I Ottaviani, PhD, Study director, Mars, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526081
- Sponsor's protocol ID
- 429275-10
- Status last verified
- May 2019
- First submitted
- 3 May 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only researchers listed in the protocol and approved by the IRB will have access to IPD.
Publications
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.
PubMed 20854838Ottaviani 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.
PubMed 22240152Koster 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.
PubMed 6946775McCullough 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.
PubMed 16794446Heiss 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.
PubMed 16198843Borges 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.
PubMed 35452808
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides
- ClinicalTrials.gov ID
- NCT03526081
- Acronym / sponsor ID
- 429275-10
- Conditions
- Healthy
- Keywords
- flavone, ADME, apigenin, parsley, chamomile, polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Cross-over dietary intervention study in healthy young adult males
| Arm | Type | Receives |
|---|---|---|
| Chamomile Tea | Experimental | Other: Chamomile TeaChamomile Tea in 300mL hot water |
| Parsley based drink | Experimental | Other: Parsley based drink3.2 g dried parsley in 300mL hot water |
| Parsley Yogurt | Experimental | Other: Parsley Yogurt3.2 g dried parsley in 100g plain yogurt |
| Apigenin | Experimental | Other: ApigeninApigenin capsule mixed with 300mL hot water |
| Parsley-based drink (II) | Experimental | Other: Parsley-based drink (II)3.2 g of dried parsley in 300 ml of hot water |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chamomile TeaChamomile Tea in 300mL hot water | Other | Chamomile Tea |
| Parsley based drink3.2 g dried parsley in 300mL hot water | Other | Parsley based drink |
| Parsley Yogurt3.2 g dried parsley in 100g plain yogurt | Other | Parsley Yogurt |
| ApigeninApigenin capsule mixed with 300mL hot water | Other | Apigenin |
| Parsley-based drink (II)3.2 g dried parsley in 300mL hot water | Other | Parsley-based drink (II) |
Primary outcome
Flavone metabolites in plasma
Time frame: before to 6 h post test material intake
Concentration of flavone metabolites in plasma
Flavone metabolites in urine
Time frame: 12 h before to 24 h post test material intake
Amount of flavone metabolites excreted in urine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Background: PubMed 20854838Schroeter 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.
- Background: PubMed 22240152Ottaviani 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.
- Background: PubMed 6946775Koster 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.
- Background: PubMed 16794446McCullough 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.
- Background: PubMed 16198843Heiss 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.
- Derived from this study: PubMed 35452808Borges 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.
- Individual participant dataSharing planned: Yes. Only researchers listed in the protocol and approved by the IRB will have access to IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl L Keen, PhD principal investigator
UC Davis
Javier I Ottaviani, PhD study director
Mars, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chamomile Tea, Parsley based drink and Parsley Yogurt in people with Healthy, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavone metabolites in plasma (time frame: before to 6 h post test material intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526081, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.