HealthyNCT03526094
Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes
A study testing Flavanols-capsules, Flavanol-banana blend and Flavanol-high protein drink in people with Healthy, run by University of California, Davis at 2 sites in United States.
Trial summary
Dietary intervention study in healthy adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of flavanols from different fruit-based drinks. 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?
- Flavanols-capsules, Flavanol-banana blend and Flavanol-high protein drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2016to 9 Feb 2018
- 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 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.
- 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
Dietary intervention study in healthy adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of flavanols from different fruit-based drinks.
Read the detailed description
Flavonoids, including the sub groups of 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, the investigators 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 as well as F-metabolites derived from the metabolic activity of the gut microbiome. 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 the xenobiotic ingested. In this context, the investigators submit it is important to assess whether or not there are food matrix-dependent effects on the levels and profile of F-derived metabolites in humans. The investigators 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 and increasing interest in the putative health effects of F intake in humans.
This study consisted of two parts. One part investigated flavanols absorption and metabolism from different fruit-based drinks and other food matrixes. The second part investigated flavanol absorption and metabolism after the intake of a flavanol drink alone and simultaneously consumed with a banana-based drink.
Following the beginning of the trial, an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis https://doi.org/10.1093/jaoacint/qsaa132). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of our intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to our intervention, the total cocoa flavanol content of select arms in our trials have been updated accordingly.
- Conditions
- Healthy
- Being tested
- Flavanols-capsules, Flavanol-banana blend, Flavanol-high protein drink, Flavanol-berry blend, Flavanol-sports drink
- Keywords
- flavanol, ADME, polyphenols, Cocoa, Banana, epicatechin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanols-capsulesOther
Capsules containing 456 mg cocoa flavanols and 315 g of milk (1% fat)
Flavanol-banana blendOther
Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 626 mg cocoa flavanols
Flavanol-high protein drinkOther
Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 533 mg cocoa flavanols
Flavanol-berry blendOther
Flavanol-berry blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 561 mg cocoa flavanols
Flavanol-sports drinkOther
Drink prepared by mixing 488 g of a sports drink with a CF powder containing 533 mg cocoa flavanols
Flavanol-peanut butter toastOther
Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 602 mg cocoa flavanols and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries
Flavanol-oatsOther
Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 602 mg cocoa flavanols
Flavanol-yogurtOther
Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 561 mg cocoa flavanols
II- Flavanol drinkOther
Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 626 mg cocoa flavanols
II- Flavanol drink + banana blendOther
Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 626 mg cocoa flavanols Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas
| Study group | Role | What they receive |
|---|---|---|
| Flavanols-capsules | Active comparator | Capsules containing 541 mg cocoa flavanols (75 mg epicatechin) and 315 g of milk (1% fat) Receives: Other: Flavanols-capsules |
| Flavanol-banana blend | Experimental | Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin) Receives: Other: Flavanol-banana blend |
| Flavanol-high protein drink | Experimental | Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin) Receives: Other: Flavanol-high protein drink |
| Flavanol-berry blend | Experimental | Fruit blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin) Receives: Other: Flavanol-berry blend |
| Flavanol-sports drink | Experimental | Drink prepared by mixing 488 g of a sports drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin) Receives: Other: Flavanol-sports drink |
| Flavanol-peanut butter toast | Experimental | Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin) and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries Receives: Other: Flavanol-peanut butter toast |
| Flavanol-oats | Experimental | Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin) Receives: Other: Flavanol-oats |
| Flavanol-yogurt | Experimental | Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin) Receives: Other: Flavanol-yogurt |
| II- Flavanol drink | Active comparator | Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin) Receives: Other: II- Flavanol drink |
| II- Flavanol drink + banana blend | Experimental | Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 638 mg cocoa flavanols (88 mg epicatechin) Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas Receives: Other: II- Flavanol drink + banana blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavanol metabolites in plasma
Plasma concentration of flavanol metabolites
Measured: Before to 6 h post test material intake
Secondary outcomes (1)
Flavanol metabolites in urine
Amount of flavanols 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 start5 May 2016
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
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
- Cross-over dietary intervention study in healthy young adult males
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 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
- NCT03526094
- Sponsor's protocol ID
- 429275-D
- Status last verified
- Oct 2022
- First submitted
- 3 May 2018
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes
- ClinicalTrials.gov ID
- NCT03526094
- Acronym / sponsor ID
- 429275-D
- Conditions
- Healthy
- Keywords
- flavanol, ADME, polyphenols, Cocoa, Banana, epicatechin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- 5 May 2016 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (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.
Dietary intervention study in healthy adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of flavanols from different fruit-based drinks.
Detailed description
Flavonoids, including the sub groups of 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, the investigators 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 as well as F-metabolites derived from the metabolic activity of the gut microbiome. 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 the xenobiotic ingested. In this context, the investigators submit it is important to assess whether or not there are food matrix-dependent effects on the levels and profile of F-derived metabolites in humans. The investigators 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 and increasing interest in the putative health effects of F intake in humans.
This study consisted of two parts. One part investigated flavanols absorption and metabolism from different fruit-based drinks and other food matrixes. The second part investigated flavanol absorption and metabolism after the intake of a flavanol drink alone and simultaneously consumed with a banana-based drink.
Following the beginning of the trial, an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis https://doi.org/10.1093/jaoacint/qsaa132). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of our intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to our intervention, the total cocoa flavanol content of select arms in our trials have been updated accordingly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 10
- Model description
- Cross-over dietary intervention study in healthy young adult males
| Arm | Type | Receives |
|---|---|---|
| Flavanols-capsules | Active comparator | Other: Flavanols-capsulesCapsules containing 541 mg cocoa flavanols (75 mg epicatechin) and 315 g of milk (1% fat) |
| Flavanol-banana blend | Experimental | Other: Flavanol-banana blendFruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin) |
| Flavanol-high protein drink | Experimental | Other: Flavanol-high protein drinkDrink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin) |
| Flavanol-berry blend | Experimental | Other: Flavanol-berry blendFruit blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin) |
| Flavanol-sports drink | Experimental | Other: Flavanol-sports drinkDrink prepared by mixing 488 g of a sports drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin) |
| Flavanol-peanut butter toast | Experimental | Other: Flavanol-peanut butter toastPrepared by mixing 32 g peanut butter with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin) and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries |
| Flavanol-oats | Experimental | Other: Flavanol-oatsPrepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin) |
| Flavanol-yogurt | Experimental | Other: Flavanol-yogurtPrepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin) |
| II- Flavanol drink | Active comparator | Other: II- Flavanol drinkDrink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin) |
| II- Flavanol drink + banana blend | Experimental | Other: II- Flavanol drink + banana blendDrink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 638 mg cocoa flavanols (88 mg epicatechin) Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas |
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 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.
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 |
|---|---|---|
| Flavanols-capsulesCapsules containing 456 mg cocoa flavanols and 315 g of milk (1% fat) | Other | Flavanols-capsules |
| Flavanol-banana blendFruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 626 mg cocoa flavanols | Other | Flavanol-banana blend |
| Flavanol-high protein drinkDrink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 533 mg cocoa flavanols | Other | Flavanol-high protein drink |
| Flavanol-berry blendFlavanol-berry blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 561 mg cocoa flavanols | Other | Flavanol-berry blend |
| Flavanol-sports drinkDrink prepared by mixing 488 g of a sports drink with a CF powder containing 533 mg cocoa flavanols | Other | Flavanol-sports drink |
| Flavanol-peanut butter toastPrepared by mixing 32 g peanut butter with a chocolate flavored powder containing 602 mg cocoa flavanols and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries | Other | Flavanol-peanut butter toast |
| Flavanol-oatsPrepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 602 mg cocoa flavanols | Other | Flavanol-oats |
| Flavanol-yogurtPrepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 561 mg cocoa flavanols | Other | Flavanol-yogurt |
| II- Flavanol drinkDrink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 626 mg cocoa flavanols | Other | II- Flavanol drink |
| II- Flavanol drink + banana blendDrink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 626 mg cocoa flavanols Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas | Other | II- Flavanol drink + banana blend |
Primary outcome
Flavanol metabolites in plasma
Time frame: Before to 6 h post test material intake
Plasma concentration of flavanol metabolites
1 secondary outcome
Flavanol metabolites in urine
Time frame: 12 h before to 24 h post test material intake
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 10 Oct 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavanols-capsules, Flavanol-banana blend and Flavanol-high protein drink 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 10 Oct 2022. 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?
Flavanol metabolites in plasma (time frame: Before to 6 h post test material intake). 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 NCT03526094, 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 10 Oct 2022; AzTrials last refreshed its copy on 4 Nov 2026.