HealthyNCT01483508
Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans
A study testing Flavanol- and procyanidins-containing drink, Procyanidins-containing drink and Flavanol-containing drink in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not the intake of dietary procyanidins (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flavanol- and procyanidins-containing drink, Procyanidins-containing drink and Flavanol-containing drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2008
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A normal blood chemistry and liver function
- Fasting blood cholesterol and triglycerides < 300 mg/dl and < 3.0 mmol/l, respectively
- BMI < 30 kg/m2 will be considered.
- Volunteers must be able to read and speak English fluently, and thus, fully understand the researchers, research protocols, and their rights as a research volunteer.
Who cannot join
- A history of cardiovascular disease, stroke, uncontrolled hypertension (> 160/90 mm), renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
- A history of psychiatric illness or an allergy to peanuts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Dietary Cocoa Procyanidins to the Systemic Presence of Flavanols Metabolites in Humans
The purpose of this study is to determine whether or not the intake of dietary procyanidins (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.
Read the detailed description
Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds normally present in the human diet. Accumulating data demonstrate a causal role for flavanols in mediating the cardiovascular benefits associated with the consumption of flavanol-/procyanidin-containing foods. Evidence for a direct, causal role for procyanidins in this context is far less profound. As this is often based on the poor absorption of procyanidins, it has been proposed that procyanidins may indirectly contribute to the systemic presence of bioactive compounds via derivatives generated from the breakdown or catabolism of procyanidins in the gastrointestinal tract. These postulated 'breakdown products' include: i) flavanols, putatively generated by acid hydrolysis in the stomach, and ii) series of phenolic compounds, including 5-(3,4-dihydroxyphenyl)-gamma-valerolactone, that are produced from procyanidin catabolism by the gut microbiome. Verification or rejection of these suppositions could significantly impact the interpretation of epidemiological-/dietary intervention data, and the design of food-content data bases. To address this question, healthy volunteers will consume specially designed cocoa-based dairy drinks containing flavanols and procyanidins (dimers to decamers) either together or individually.
- Conditions
- Healthy
- Being tested
- Flavanol- and procyanidins-containing drink, Procyanidins-containing drink, Flavanol-containing drink
- Keywords
- flavanols, procyanidins, absorption, cocoa polyphenols, Flavanol and procyanidin absorption in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol- and procyanidins-containing drinkOther
Also called Cocoa-based dairy drink
Single oral intake of a cocoa-based dairy drink containing flavanols [monomer] and procyanidins [dimers to decamers]
Procyanidins-containing drinkOther
Also called Cocoa-based dairy drink
Single oral intake of a ocoa-based dairy drink containing procyanidins [dimers to decamers]
Flavanol-containing drinkOther
Also called cocoa-based dairy drink
Single oral intake of a cocoa-based dairy drink containing flavanols [monomers]
| Study group | Role | What they receive |
|---|---|---|
| Flavanol and procyanidins | Active comparator | Not described Receives: Other: Flavanol- and procyanidins-containing drink |
| Flavanols only | Experimental | Not described Receives: Other: Flavanol-containing drink |
| Procyanidins only | Experimental | Not described Receives: Other: Procyanidins-containing drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve described by the concentration of flavanol metabolites in plasma versus time
The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
Measured: After consumption at time points 0, 1, 2 and 4 h
Peak plasma concentration of flavanol metabolites
The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
Measured: After consumption at time points 0, 1, 2 and 4 h
Secondary outcomes (2)
Amount of flavanol metabolites excreted in urine
The amount of flavanol metabolites excreted in urine is expressed in µmol. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
Measured: urine collected up to 24h post-consumption
Amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites in urine
The amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites excreted in urine is expressed in µmol. 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites encompass a series of O-sulfonated and O-glucuronidated derivatives generated in the gastrointestinal tract and liver after 5-(3,4-dihydroxyphenyl)-gamma-valerolactone absorption.
Measured: urine collected up to 24 h post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl L Keen, PhD, Study chair, Department of Nutition, University of California DavisJavier I Ottaviani, PhD, Principal investigator, Department of Nutrition, University of California Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483508
- Sponsor's protocol ID
- 200513038
- Status last verified
- Oct 2012
- First submitted
- 28 Nov 2011
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Heiss C, Keen CL, Kelm M. Flavanols and cardiovascular disease prevention. Eur Heart J. 2010 Nov;31(21):2583-92. doi: 10.1093/eurheartj/ehq332. Epub 2010 Sep 18.
PubMed 20852295Manach C, Williamson G, Morand C, Scalbert A, Remesy C. Bioavailability and bioefficacy of polyphenols in humans. I. Review of 97 bioavailability studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):230S-242S. doi: 10.1093/ajcn/81.1.230S.
PubMed 15640486Crozier A, Del Rio D, Clifford MN. Bioavailability of dietary flavonoids and phenolic compounds. Mol Aspects Med. 2010 Dec;31(6):446-67. doi: 10.1016/j.mam.2010.09.007. Epub 2010 Sep 18.
PubMed 20854839Rios LY, Bennett RN, Lazarus SA, Remesy C, Scalbert A, Williamson G. Cocoa procyanidins are stable during gastric transit in humans. Am J Clin Nutr. 2002 Nov;76(5):1106-10. doi: 10.1093/ajcn/76.5.1106.
PubMed 12399286Holt RR, Lazarus SA, Sullards MC, Zhu QY, Schramm DD, Hammerstone JF, Fraga CG, Schmitz HH, Keen CL. Procyanidin dimer B2 [epicatechin-(4beta-8)-epicatechin] in human plasma after the consumption of a flavanol-rich cocoa. Am J Clin Nutr. 2002 Oct;76(4):798-804. doi: 10.1093/ajcn/76.4.798.
PubMed 12324293Gonthier MP, Donovan JL, Texier O, Felgines C, Remesy C, Scalbert A. Metabolism of dietary procyanidins in rats. Free Radic Biol Med. 2003 Oct 15;35(8):837-44. doi: 10.1016/s0891-5849(03)00394-0.
PubMed 14556848Ottaviani 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 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Dietary Cocoa Procyanidins to the Systemic Presence of Flavanols Metabolites in Humans
- ClinicalTrials.gov ID
- NCT01483508
- Acronym / sponsor ID
- 200513038
- Conditions
- Healthy
- Keywords
- flavanols, procyanidins, absorption, cocoa polyphenols, Flavanol and procyanidin absorption in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 1 Dec 2011 (estimated)
- 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 purpose of this study is to determine whether or not the intake of dietary procyanidins (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.
Detailed description
Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds normally present in the human diet. Accumulating data demonstrate a causal role for flavanols in mediating the cardiovascular benefits associated with the consumption of flavanol-/procyanidin-containing foods. Evidence for a direct, causal role for procyanidins in this context is far less profound. As this is often based on the poor absorption of procyanidins, it has been proposed that procyanidins may indirectly contribute to the systemic presence of bioactive compounds via derivatives generated from the breakdown or catabolism of procyanidins in the gastrointestinal tract. These postulated 'breakdown products' include: i) flavanols, putatively generated by acid hydrolysis in the stomach, and ii) series of phenolic compounds, including 5-(3,4-dihydroxyphenyl)-gamma-valerolactone, that are produced from procyanidin catabolism by the gut microbiome. Verification or rejection of these suppositions could significantly impact the interpretation of epidemiological-/dietary intervention data, and the design of food-content data bases. To address this question, healthy volunteers will consume specially designed cocoa-based dairy drinks containing flavanols and procyanidins (dimers to decamers) either together or individually.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flavanol and procyanidins | Active comparator | Other: Flavanol- and procyanidins-containing drink |
| Flavanols only | Experimental | Other: Flavanol-containing drink |
| Procyanidins only | Experimental | Other: Procyanidins-containing drink |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A normal blood chemistry and liver function
- Fasting blood cholesterol and triglycerides < 300 mg/dl and < 3.0 mmol/l, respectively
- BMI < 30 kg/m2 will be considered.
- Volunteers must be able to read and speak English fluently, and thus, fully understand the researchers, research protocols, and their rights as a research volunteer.
Key exclusion criteria (2 listed)
- A history of cardiovascular disease, stroke, uncontrolled hypertension (> 160/90 mm), renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
- A history of psychiatric illness or an allergy to peanuts.
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 |
|---|---|---|
| Flavanol- and procyanidins-containing drinkAlso: Cocoa-based dairy drinkSingle oral intake of a cocoa-based dairy drink containing flavanols [monomer] and procyanidins [dimers to decamers] | Other | Flavanol and procyanidins |
| Procyanidins-containing drinkAlso: Cocoa-based dairy drinkSingle oral intake of a ocoa-based dairy drink containing procyanidins [dimers to decamers] | Other | Procyanidins only |
| Flavanol-containing drinkAlso: cocoa-based dairy drinkSingle oral intake of a cocoa-based dairy drink containing flavanols [monomers] | Other | Flavanols only |
Primary outcome
Area under the curve described by the concentration of flavanol metabolites in plasma versus time
Time frame: After consumption at time points 0, 1, 2 and 4 h
The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
Peak plasma concentration of flavanol metabolites
Time frame: After consumption at time points 0, 1, 2 and 4 h
The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.
2 secondary outcomes
Amount of flavanol metabolites excreted in urine
Time frame: urine collected up to 24h post-consumption
Amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites in urine
Time frame: urine collected up to 24 h post-consumption
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 25 Oct 2012.
- Background: PubMed 20852295Heiss C, Keen CL, Kelm M. Flavanols and cardiovascular disease prevention. Eur Heart J. 2010 Nov;31(21):2583-92. doi: 10.1093/eurheartj/ehq332. Epub 2010 Sep 18.
- Background: PubMed 15640486Manach C, Williamson G, Morand C, Scalbert A, Remesy C. Bioavailability and bioefficacy of polyphenols in humans. I. Review of 97 bioavailability studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):230S-242S. doi: 10.1093/ajcn/81.1.230S.
- Background: PubMed 20854839Crozier A, Del Rio D, Clifford MN. Bioavailability of dietary flavonoids and phenolic compounds. Mol Aspects Med. 2010 Dec;31(6):446-67. doi: 10.1016/j.mam.2010.09.007. Epub 2010 Sep 18.
- Background: PubMed 12399286Rios LY, Bennett RN, Lazarus SA, Remesy C, Scalbert A, Williamson G. Cocoa procyanidins are stable during gastric transit in humans. Am J Clin Nutr. 2002 Nov;76(5):1106-10. doi: 10.1093/ajcn/76.5.1106.
- Background: PubMed 12324293Holt RR, Lazarus SA, Sullards MC, Zhu QY, Schramm DD, Hammerstone JF, Fraga CG, Schmitz HH, Keen CL. Procyanidin dimer B2 [epicatechin-(4beta-8)-epicatechin] in human plasma after the consumption of a flavanol-rich cocoa. Am J Clin Nutr. 2002 Oct;76(4):798-804. doi: 10.1093/ajcn/76.4.798.
- Background: PubMed 14556848Gonthier MP, Donovan JL, Texier O, Felgines C, Remesy C, Scalbert A. Metabolism of dietary procyanidins in rats. Free Radic Biol Med. 2003 Oct 15;35(8):837-44. doi: 10.1016/s0891-5849(03)00394-0.
- Derived from this study: 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.
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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 study chair
Department of Nutition, University of California Davis
Javier I Ottaviani, PhD principal investigator
Department of Nutrition, University of California Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavanol- and procyanidins-containing drink, Procyanidins-containing drink and Flavanol-containing drink 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 4 inclusion and 2 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 25 Oct 2012. 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. 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?
Area under the curve described by the concentration of flavanol metabolites in plasma versus time (time frame: After consumption at time points 0, 1, 2 and 4 h). 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 NCT01483508, 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 25 Oct 2012.