HealthyNCT03194620
Absorption, Metabolism and Excretion of Dietary Polyphenolic Bioactives in Humans
A study testing Thearubigins, Theaflavins and Procyanidin Dimer B2 (DB2) in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
The objectives of this study are to i) describe the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetic parameters of selected dietary (poly)phenols in humans; and ii) to compare the ADME and pharmacokinetic parameters of selected dietary (poly)phenols in humans. 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?
- Thearubigins, Theaflavins and Procyanidin Dimer B2 (DB2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 12 Jan 2017
- 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
- 25-60 years old males
- No prescription medications
- BMI 18.5 - 34.9 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
- Females
- Prisoners
- Non-English speaking*
- BMI ≥ 35 kg/m2
- Performing vigorous physical activity (i.e. more than 6 MET; metabolic equivalence of task as defined by CDC and ACSM guidelines (http://www.cdc.gov/physicalactivity/everyone/glossary/index.html#vig-intensity; and http://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA_Intensity_table_2_1.pdf ) for more than 3 days a week.
Show all 23Show fewer
- Dietary allergies including those to nuts, cocoa and chocolate products, parsley, celery and chamomile.
- Active avoidance of either 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
1 site in 1 country.
About this study
The objectives of this study are to i) describe the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetic parameters of selected dietary (poly)phenols in humans; and ii) to compare the ADME and pharmacokinetic parameters of selected dietary (poly)phenols in humans.
Read the detailed description
Dietary (poly)phenols are a large group of bioactive food constituents that can be classified in flavonoids, stilbenes, lignans and phenolic acids. Flavonoids can be subclassified in different subgroups, including but not limited to flavanols (e.g. (-)-epicatechin, (+)-catechin, procyanidins, EGCG, EGC, etc) and flavones (apigenin and luteolin). Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. Examples of flavone-containing foods and beverages are parsley, celery, and chamomile.
(Poly)phenolic bioactives are actively investigated for their putative beneficial health effects in humans. In this context, understanding the ADME of dietary (poly)phenols is recognized as a key step to gain insight into the nutritional and biomedical relevance of this group of compounds. Understanding the ADME of polyphenols may aid towards i) the identification of metabolites as potential nutritional biomarkers of (poly)phenol consumption, ii) the identification of potential active metabolites mediating the effects observed after (poly)phenol intake, and iii) the design and execution of dietary intervention studies aiming at assess safety and efficacy of (poly)phenols.
Over the last years, significant progress has been made on the description of the ADME of certain (poly)phenols. The investigators recently described the ADME of (-)-epicatechin. However, there is still need to understand the ADME of other polyphenolic bioactives as well as the importance of the role of the gut microbiome in the metabolism of these compounds. In this context, the investigators aim at describing and comparing the ADME of dietary polyphenolic bioactives in humans. To accomplish this, the investigators propose conducting a randomized, double-masked and cross-over dietary intervention study in healthy young adult males. The investigators will evaluate the concentration of polyphenol-derived metabolites in plasma and urine after single acute intakes of polyphenol-containing test materials on 8 different test days.
- Conditions
- Healthy
- Being tested
- Thearubigins, Theaflavins, Procyanidin Dimer B2 (DB2), (-)-Epigallocatechin-3-O-gallate (EGCG), (-)-Epicatechin-3-O-gallate (ECG)
- Keywords
- Flavanols, Cocoa Flavanols, Epicatechins, Polyphenols, Procyanidins, EGCG, EGC, ECG, Theaflavins, Thearubigins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThearubiginsOther
Single oral intake of 94.9 mg of therubigins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink
TheaflavinsOther
Single oral intake of 120 µmol of an equimolar mixture of theaflavins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink. The theaflavin mix includes theaflavin, theaflavin-3-gallate and theaflavin-3,3'-gallate
Procyanidin Dimer B2 (DB2)Other
Single oral intake of 120 µmol of Procyanidin Dimer B2 (DB2) (isolated from Theobroma cacao) in a flavanol-free, fruit flavored, non-dairy drink.
(-)-Epigallocatechin-3-O-gallate (EGCG)Other
Single oral intake of 120 µmol of (-)-Epigallocatechin-3-O-gallate (EGCG)(isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
(-)-Epicatechin-3-O-gallate (ECG)Other
Single oral intake of 120 µmol of (-)-Epicatechin-3-O-gallate (ECG) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
(-)-Epicatechin (EC)Other
Single oral intake of 120 µmol of (-)-Epicatechin (EC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
(-)-Epigallocatechin (EGC)Other
Single oral intake of 120 µmol of (-)-Epigallocatechin (EGC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
ControlOther
Single oral intake of a flavanol-free, fruit flavored, non-dairy drink.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Single oral intake of flavanol-free fruit-flavored non-dairy drink Receives: Other: Control |
| Theaflavins | Experimental | Single oral intake of a fruit-flavored non-dairy drink containing a mixture of theaflavins Receives: Other: Theaflavins |
| Procyanidin Dimer B2 (DB2) | Experimental | Single oral intake of a fruit-flavored non-dairy drink containing Procyanidin Dimer B2 (DB2) Receives: Other: Procyanidin Dimer B2 (DB2) |
| (-)-Epigallocatechin-3-O-gallate (EGCG) | Experimental | Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epigallocatechin-3-O-gallate (EGCG) Receives: Other: (-)-Epigallocatechin-3-O-gallate (EGCG) |
| (-)-Epicatechin-3-O-gallate (ECG) | Experimental | Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epicatechin-3-O-gallate (ECG) Receives: Other: (-)-Epicatechin-3-O-gallate (ECG) |
| (-)-Epicatechin (EC) | Active comparator | Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epicatechin (EC) Receives: Other: (-)-Epicatechin (EC) |
| (-)-Epigallocatechin (EGC) | Experimental | Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epigallocatechin (EGC) Receives: Other: (-)-Epigallocatechin (EGC) |
| Thearubigins | Experimental | Single oral intake of a fruit-flavored non-dairy drink containing thearubigins Receives: Other: Thearubigins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the concentration of flavanol metabolites in urine.
Flavanol metabolites include gut microbiome derived metabolites include conjugates of 5-(3',4'-dihydroxyphenyl)-g-valerolactone metabolites and structurally related flavanol conjugated metabolites.
Measured: Urine collected 12h previous to intervention and up to 24 h after intervention
Changes in the concentration of flavanol metabolites in plasma
Flavanol metabolites include gut microbiome-derived metabolites like 5-(3',4'-dihydroxyphenyl)-g-valerolactone and structurally related flavanol conjugated metabolites.
Measured: Plasma collected before (0h) and up to 6h post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startAug 2016
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-masked and cross-over dietary intervention study in healthy young adult males
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 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
- NCT03194620
- Sponsor's protocol ID
- 907244
- Status last verified
- Oct 2017
- First submitted
- 19 Jun 2017
- Last updated
- 6 Nov 2017
- 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 16198843Del Rio D, Rodriguez-Mateos A, Spencer JP, Tognolini M, Borges G, Crozier A. Dietary (poly)phenolics in human health: structures, bioavailability, and evidence of protective effects against chronic diseases. Antioxid Redox Signal. 2013 May 10;18(14):1818-92. doi: 10.1089/ars.2012.4581. Epub 2012 Aug 27.
PubMed 22794138Ottaviani JI, Kwik-Uribe C, Keen CL, Schroeter H. Intake of dietary procyanidins does not contribute to the pool of circulating flavanols in humans. Am J Clin Nutr. 2012 Apr;95(4):851-8. doi: 10.3945/ajcn.111.028340. Epub 2012 Feb 29.
PubMed 22378733
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Metabolism and Excretion of Dietary Polyphenolic Bioactives in Humans
- ClinicalTrials.gov ID
- NCT03194620
- Acronym / sponsor ID
- 907244
- Conditions
- Healthy
- Keywords
- Flavanols, Cocoa Flavanols, Epicatechins, Polyphenols, Procyanidins, EGCG, EGC, ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- Aug 2016 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 21 Jun 2017 (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.
The objectives of this study are to i) describe the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetic parameters of selected dietary (poly)phenols in humans; and ii) to compare the ADME and pharmacokinetic parameters of selected dietary (poly)phenols in humans.
Detailed description
Dietary (poly)phenols are a large group of bioactive food constituents that can be classified in flavonoids, stilbenes, lignans and phenolic acids. Flavonoids can be subclassified in different subgroups, including but not limited to flavanols (e.g. (-)-epicatechin, (+)-catechin, procyanidins, EGCG, EGC, etc) and flavones (apigenin and luteolin). Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. Examples of flavone-containing foods and beverages are parsley, celery, and chamomile.
(Poly)phenolic bioactives are actively investigated for their putative beneficial health effects in humans. In this context, understanding the ADME of dietary (poly)phenols is recognized as a key step to gain insight into the nutritional and biomedical relevance of this group of compounds. Understanding the ADME of polyphenols may aid towards i) the identification of metabolites as potential nutritional biomarkers of (poly)phenol consumption, ii) the identification of potential active metabolites mediating the effects observed after (poly)phenol intake, and iii) the design and execution of dietary intervention studies aiming at assess safety and efficacy of (poly)phenols.
Over the last years, significant progress has been made on the description of the ADME of certain (poly)phenols. The investigators recently described the ADME of (-)-epicatechin. However, there is still need to understand the ADME of other polyphenolic bioactives as well as the importance of the role of the gut microbiome in the metabolism of these compounds. In this context, the investigators aim at describing and comparing the ADME of dietary polyphenolic bioactives in humans. To accomplish this, the investigators propose conducting a randomized, double-masked and cross-over dietary intervention study in healthy young adult males. The investigators will evaluate the concentration of polyphenol-derived metabolites in plasma and urine after single acute intakes of polyphenol-containing test materials on 8 different test days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Randomized, double-masked and cross-over dietary intervention study in healthy young adult males
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlSingle oral intake of flavanol-free fruit-flavored non-dairy drink |
| Theaflavins | Experimental | Other: TheaflavinsSingle oral intake of a fruit-flavored non-dairy drink containing a mixture of theaflavins |
| Procyanidin Dimer B2 (DB2) | Experimental | Other: Procyanidin Dimer B2 (DB2)Single oral intake of a fruit-flavored non-dairy drink containing Procyanidin Dimer B2 (DB2) |
| (-)-Epigallocatechin-3-O-gallate (EGCG) | Experimental | Other: (-)-Epigallocatechin-3-O-gallate (EGCG)Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epigallocatechin-3-O-gallate (EGCG) |
| (-)-Epicatechin-3-O-gallate (ECG) | Experimental | Other: (-)-Epicatechin-3-O-gallate (ECG)Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epicatechin-3-O-gallate (ECG) |
| (-)-Epicatechin (EC) | Active comparator | Other: (-)-Epicatechin (EC)Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epicatechin (EC) |
| (-)-Epigallocatechin (EGC) | Experimental | Other: (-)-Epigallocatechin (EGC)Single oral intake of a fruit-flavored non-dairy drink containing (-)-Epigallocatechin (EGC) |
| Thearubigins | Experimental | Other: ThearubiginsSingle oral intake of a fruit-flavored non-dairy drink containing thearubigins |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 25-60 years old males
- No prescription medications
- BMI 18.5 - 34.9 kg/m2
- Weight ≥ 110 pounds
- previously consumed cocoa, peanut, parsley, celery and chamomile products with no adverse reactions
Key exclusion criteria (23 listed)
- Adults unable to consent
- Females
- Prisoners
- Non-English speaking*
- BMI ≥ 35 kg/m2
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 |
|---|---|---|
| ThearubiginsSingle oral intake of 94.9 mg of therubigins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink | Other | Thearubigins |
| TheaflavinsSingle oral intake of 120 µmol of an equimolar mixture of theaflavins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink. The theaflavin mix includes theaflavin, theaflavin-3-gallate and theaflavin-3,3'-gallate | Other | Theaflavins |
| Procyanidin Dimer B2 (DB2)Single oral intake of 120 µmol of Procyanidin Dimer B2 (DB2) (isolated from Theobroma cacao) in a flavanol-free, fruit flavored, non-dairy drink. | Other | Procyanidin Dimer B2 (DB2) |
| (-)-Epigallocatechin-3-O-gallate (EGCG)Single oral intake of 120 µmol of (-)-Epigallocatechin-3-O-gallate (EGCG)(isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink. | Other | (-)-Epigallocatechin-3-O-gallate (EGCG) |
| (-)-Epicatechin-3-O-gallate (ECG)Single oral intake of 120 µmol of (-)-Epicatechin-3-O-gallate (ECG) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink. | Other | (-)-Epicatechin-3-O-gallate (ECG) |
| (-)-Epicatechin (EC)Single oral intake of 120 µmol of (-)-Epicatechin (EC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink. | Other | (-)-Epicatechin (EC) |
| (-)-Epigallocatechin (EGC)Single oral intake of 120 µmol of (-)-Epigallocatechin (EGC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink. | Other | (-)-Epigallocatechin (EGC) |
| ControlSingle oral intake of a flavanol-free, fruit flavored, non-dairy drink. | Other | Control |
Primary outcome
Changes in the concentration of flavanol metabolites in urine.
Time frame: Urine collected 12h previous to intervention and up to 24 h after intervention
Flavanol metabolites include gut microbiome derived metabolites include conjugates of 5-(3',4'-dihydroxyphenyl)-g-valerolactone metabolites and structurally related flavanol conjugated metabolites.
Changes in the concentration of flavanol metabolites in plasma
Time frame: Plasma collected before (0h) and up to 6h post intervention
Flavanol metabolites include gut microbiome-derived metabolites like 5-(3',4'-dihydroxyphenyl)-g-valerolactone and structurally related flavanol conjugated metabolites.
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 6 Nov 2017.
- 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.
- Background: PubMed 22794138Del Rio D, Rodriguez-Mateos A, Spencer JP, Tognolini M, Borges G, Crozier A. Dietary (poly)phenolics in human health: structures, bioavailability, and evidence of protective effects against chronic diseases. Antioxid Redox Signal. 2013 May 10;18(14):1818-92. doi: 10.1089/ars.2012.4581. Epub 2012 Aug 27.
- Background: PubMed 22378733Ottaviani JI, Kwik-Uribe C, Keen CL, Schroeter H. Intake of dietary procyanidins does not contribute to the pool of circulating flavanols in humans. Am J Clin Nutr. 2012 Apr;95(4):851-8. doi: 10.3945/ajcn.111.028340. Epub 2012 Feb 29.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thearubigins, Theaflavins and Procyanidin Dimer B2 (DB2) in people with Healthy, run by University of California, Davis at 1 site 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 5 inclusion and 23 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Changes in the concentration of flavanol metabolites in urine. (time frame: Urine collected 12h previous to intervention and up to 24 h after intervention). 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 NCT03194620, which also lists 7 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 6 Nov 2017.