HealthyNCT03201822
Intake-dependent Effect of Cocoa Flavanol Absorption, Metabolism and Excretion in Humans
A study testing 100 mg of Cocoa Flavanols/70 kg BW, 200 mg of Cocoa Flavanols/70 kg BW and 400 mg of Cocoa Flavanols/70 kg BW in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
A randomized, double-masked and cross-over dietary intervention study in healthy young adult males to evaluate the concentration of F-derived metabolites in plasma and urine after single acute intakes of F-containing drinks on four different test days. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 100 mg of Cocoa Flavanols/70 kg BW, 200 mg of Cocoa Flavanols/70 kg BW and 400 mg of Cocoa Flavanols/70 kg BW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2013to 25 May 2013
- 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 40 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 and peanut products, with no adverse reactions
Who cannot join
- Adults unable to consent
- Prisoners
- Non-English speaking*
- BMI ≥ 30 kg/m2
- Allergies to nuts, cocoa and chocolate products
- Active avoidance of coffee and caffeinated soft drinks
Show all 25Show fewer
- 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 month, or antibiotic intake within the last month
- Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet
- Metabolic panel results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician
- Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL)
- Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL).
- (using NCEP calculator http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof)
- Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL), and a Framingham 10-year Risk Score 10-20% (Framingham risk calculated using NCEP calculator http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof)
- 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
A randomized, double-masked and cross-over dietary intervention study in healthy young adult males to evaluate the concentration of F-derived metabolites in plasma and urine after single acute intakes of F-containing drinks on four different test days.
Read the detailed description
Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods and beverages has been associated with improvements in cardiovascular health. In this context, there exists a great interest in describing the absorption, metabolism and excretion of F in humans, as it is thought that F-derived metabolites present in circulation are the mediators of F-beneficial effects in humans. Recently, we described a series of F-derived metabolites in circulation that are present after the consumption of a single acute intake amount of F in humans. A key question, however, is if the metabolites we observed after a single acute feeding are the same as those that occur in individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism of numerous other xenobiotics have shown that the profile of metabolites can greatly vary over time, as well as with the amount of xenobiotic ingested. In this context, and considering that i) the amount of F-consumed from diet greatly varies among individuals, ii) recent epidemiology studies indicate that the vascular protective effects of F diets primarily occur when daily intake of F are relatively high; and iii) there is evidence of an intake amount-dependency on the vascular effects of F in dietary intervention studies; we submit it is important to assess whether or not there are F intake amount-dependent effects on the levels and profile of F-derived metabolites in humans. This study will provide new information concerning the F-derived metabolites that may be responsible for mediating F-beneficial effects in humans. We suggest the information that will be obtained from the outlined work will be particularly timely given ongoing discussion concerning the possible generation of dietary recommendations for F-rich foods.
- Conditions
- Healthy
- Being tested
- 100 mg of Cocoa Flavanols/70 kg BW, 200 mg of Cocoa Flavanols/70 kg BW, 400 mg of Cocoa Flavanols/70 kg BW, 1000 mg of Cocoa Flavanols/70 kg BW
- Keywords
- flavanol, ADME, cocoa flavanols, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg of Cocoa Flavanols/70 kg BWOther
Fruit-flavored non-dairy drink containing 100 cocoa flavanols/70kg BW.
200 mg of Cocoa Flavanols/70 kg BWOther
Fruit-flavored non-dairy drink containing 200 cocoa flavanols/70kg BW.
400 mg of Cocoa Flavanols/70 kg BWOther
Fruit-flavored non-dairy drink containing 400 cocoa flavanols/70kg BW.
1000 mg of Cocoa Flavanols/70 kg BWOther
Fruit-flavored non-dairy drink containing 1000 cocoa flavanols/70kg BW.
| Study group | Role | What they receive |
|---|---|---|
| 100 mg of Cocoa Flavanols/70 kg BW | Experimental | Fruit flavored non-dairy drink containing 100 cocoa flavanol/70 kg BW Receives: Other: 100 mg of Cocoa Flavanols/70 kg BW |
| 200 mg of Cocoa Flavanols/70 kg BW | Experimental | Fruit flavored non-dairy drink containing 200 cocoa flavanol/70 kg BW Receives: Other: 200 mg of Cocoa Flavanols/70 kg BW |
| 400 mg of Cocoa Flavanols/70 kg BW | Experimental | Fruit flavored non-dairy drink containing 400 cocoa flavanol/70 kg BW Receives: Other: 400 mg of Cocoa Flavanols/70 kg BW |
| 1000 mg of Cocoa Flavanols/70 kg BW | Experimental | Fruit flavored non-dairy drink containing 1000 cocoa flavanol/70 kg BW Receives: Other: 1000 mg of Cocoa Flavanols/70 kg BW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of gut microbiome derived metabolites in urine
Gut microbiome derived metabolites include conjugates of 5-(3',4'-dihydroxyphenyl)-g-valerolatone metabolites
Measured: Urine collected 12h previous to intervention and up to 24 h after intervention
Change in levels of gut microbiome derived metabolites in plasma
Gut microbiome derived metabolites include conjugates of 5-(3',4'-dihydroxyphenyl)-g-valerolatone
Measured: Plasma collected before (0h) and up to 6h post intervention
Change in levels of structurally related epicatechin metabolites in urine
Structurally related epicatechin metabolites include sulfated, glucuronidated and/or methylated metabolites of epicatechin
Measured: Urine collected 12h previous to intervention and up to 24 h after intervention
Change in levels of structurally related epicatechin metabolites in plasma
Structurally related epicatechin metabolites include sulfated, glucuronidated and/or methylated metabolites of epicatechin
Measured: Plasma collected before (0h) and up to 6h post intervention
Secondary outcomes (11)
Composite of pharmacokinetic (PK) parameters of metabolites Maximum Plasma Concentration (CMax)
PK parameters: Cmax: maximum observed concentration in plasma;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Time to Maximum Plasma Concentration
tmax: time to maximum concentration in plasma;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Area Under the Curve
AUC0-t: area under the plasma concentration-time curve from hour 0 to the last measurable concentration in plasma;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Area Under the Curve extrapolated to infinity
AUC0-∞: area under the plasma concentration-time curve extrapolated to infinity;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Elimination Rate Constant
λZ: apparent terminal elimination rate constant in plasma;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Elimination Half-Life
t1/2: apparent terminal elimination half-life in plasma;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Systemic Clearance
CL/F: systemic clearance;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Renal Clearance
CLR: renal clearance;sampling interval and the total interval examined;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites cumulative Amount Excreted in Feces
Aef(0-t): Cumulative amount excreted in the feces over each sampling interval and the total interval examined.
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Volume of Distribution
Vd/F: apparent volume of distribution;
Measured: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites cumulative Amount Excreted in Urine
Aeu(0-t): cumulative amount excreted in the urine over each
Measured: Before intervention (0h) and up to 24 h after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Apr 2013
- Primary completion25 May 2013
- Study completion25 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 14 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
- NCT03201822
- Sponsor's protocol ID
- 429275
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 28 Jun 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 16198843
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intake-dependent Effect of Cocoa Flavanol Absorption, Metabolism and Excretion in Humans
- ClinicalTrials.gov ID
- NCT03201822
- Acronym / sponsor ID
- 429275
- Conditions
- Healthy
- Keywords
- flavanol, ADME, cocoa flavanols, polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 25 May 2013 (actual)
- Study completion
- 25 May 2013 (actual)
- First posted
- 28 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.
A randomized, double-masked and cross-over dietary intervention study in healthy young adult males to evaluate the concentration of F-derived metabolites in plasma and urine after single acute intakes of F-containing drinks on four different test days.
Detailed description
Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods and beverages has been associated with improvements in cardiovascular health. In this context, there exists a great interest in describing the absorption, metabolism and excretion of F in humans, as it is thought that F-derived metabolites present in circulation are the mediators of F-beneficial effects in humans. Recently, we described a series of F-derived metabolites in circulation that are present after the consumption of a single acute intake amount of F in humans. A key question, however, is if the metabolites we observed after a single acute feeding are the same as those that occur in individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism of numerous other xenobiotics have shown that the profile of metabolites can greatly vary over time, as well as with the amount of xenobiotic ingested. In this context, and considering that i) the amount of F-consumed from diet greatly varies among individuals, ii) recent epidemiology studies indicate that the vascular protective effects of F diets primarily occur when daily intake of F are relatively high; and iii) there is evidence of an intake amount-dependency on the vascular effects of F in dietary intervention studies; we submit it is important to assess whether or not there are F intake amount-dependent effects on the levels and profile of F-derived metabolites in humans. This study will provide new information concerning the F-derived metabolites that may be responsible for mediating F-beneficial effects in humans. We suggest the information that will be obtained from the outlined work will be particularly timely given ongoing discussion concerning the possible generation of dietary recommendations for F-rich foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-masked and cross-over dietary intervention study in healthy young adult males
| Arm | Type | Receives |
|---|---|---|
| 100 mg of Cocoa Flavanols/70 kg BW | Experimental | Other: 100 mg of Cocoa Flavanols/70 kg BWFruit flavored non-dairy drink containing 100 cocoa flavanol/70 kg BW |
| 200 mg of Cocoa Flavanols/70 kg BW | Experimental | Other: 200 mg of Cocoa Flavanols/70 kg BWFruit flavored non-dairy drink containing 200 cocoa flavanol/70 kg BW |
| 400 mg of Cocoa Flavanols/70 kg BW | Experimental | Other: 400 mg of Cocoa Flavanols/70 kg BWFruit flavored non-dairy drink containing 400 cocoa flavanol/70 kg BW |
| 1000 mg of Cocoa Flavanols/70 kg BW | Experimental | Other: 1000 mg of Cocoa Flavanols/70 kg BWFruit flavored non-dairy drink containing 1000 cocoa flavanol/70 kg BW |
Who may qualify
- Ages
- 25 to 40 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 and peanut products, with no adverse reactions
Key exclusion criteria (25 listed)
- Adults unable to consent
- Prisoners
- Non-English speaking*
- BMI ≥ 30 kg/m2
- Allergies to nuts, cocoa and chocolate products
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 |
|---|---|---|
| 100 mg of Cocoa Flavanols/70 kg BWFruit-flavored non-dairy drink containing 100 cocoa flavanols/70kg BW. | Other | 100 mg of Cocoa Flavanols/70 kg BW |
| 200 mg of Cocoa Flavanols/70 kg BWFruit-flavored non-dairy drink containing 200 cocoa flavanols/70kg BW. | Other | 200 mg of Cocoa Flavanols/70 kg BW |
| 400 mg of Cocoa Flavanols/70 kg BWFruit-flavored non-dairy drink containing 400 cocoa flavanols/70kg BW. | Other | 400 mg of Cocoa Flavanols/70 kg BW |
| 1000 mg of Cocoa Flavanols/70 kg BWFruit-flavored non-dairy drink containing 1000 cocoa flavanols/70kg BW. | Other | 1000 mg of Cocoa Flavanols/70 kg BW |
Primary outcome
Change in levels of gut microbiome derived metabolites in urine
Time frame: Urine collected 12h previous to intervention and up to 24 h after intervention
Gut microbiome derived metabolites include conjugates of 5-(3',4'-dihydroxyphenyl)-g-valerolatone metabolites
Change in levels of gut microbiome derived metabolites in plasma
Time frame: Plasma collected before (0h) and up to 6h post intervention
Gut microbiome derived metabolites include conjugates of 5-(3',4'-dihydroxyphenyl)-g-valerolatone
Change in levels of structurally related epicatechin metabolites in urine
Time frame: Urine collected 12h previous to intervention and up to 24 h after intervention
Structurally related epicatechin metabolites include sulfated, glucuronidated and/or methylated metabolites of epicatechin
Change in levels of structurally related epicatechin metabolites in plasma
Time frame: Plasma collected before (0h) and up to 6h post intervention
Structurally related epicatechin metabolites include sulfated, glucuronidated and/or methylated metabolites of epicatechin
11 secondary outcomes
Composite of pharmacokinetic (PK) parameters of metabolites Maximum Plasma Concentration (CMax)
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Time to Maximum Plasma Concentration
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Area Under the Curve
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Area Under the Curve extrapolated to infinity
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Elimination Rate Constant
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Elimination Half-Life
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Systemic Clearance
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Renal Clearance
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites cumulative Amount Excreted in Feces
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites Volume of Distribution
Time frame: Before intervention (0h) and up to 24 h after intervention
Composite of pharmacokinetic (PK) parameters of metabolites cumulative Amount Excreted in Urine
Time frame: Before intervention (0h) and up to 24 h after intervention
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 28 Jun 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.
- 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 100 mg of Cocoa Flavanols/70 kg BW, 200 mg of Cocoa Flavanols/70 kg BW and 400 mg of Cocoa Flavanols/70 kg BW 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 25 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 28 Jun 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. 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?
Change in levels of gut microbiome derived metabolites in urine (time frame: Urine collected 12h previous to intervention and up to 24 h after intervention). The study lists 4 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 NCT03201822, which also lists 5 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 28 Jun 2017.