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HealthyNCT03526107

Food Matrix Effect on Flavanol Absorption, Metabolism and Excretion: Methylxanthines

A study testing CF-Theobromine and CF-Caffeine in people with Healthy, run by University of California, Davis at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dietary intervention study in healthy young adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of methylxanthines. 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?
CF-Theobromine and CF-Caffeine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
16 Feb 2017to 31 May 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

  • 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

Other trials in United States

About this study

Dietary intervention study in healthy young adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of methylxanthines.

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 the investigators 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.

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
CF Control, CF-Theobromine, CF-Caffeine
Keywords
flavanol, ADME, polyphenols, cocoa, epicatechin, methylxanthine, caffeine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF ControlOther

    CF Control: 587 mg of cocoa flavanols, <1 mg caffeine and <1 mg theobromine

  • CF-TheobromineOther

    CF-Theobromine: 575 mg of cocoa flavanols, 11 mg caffeine and 93 mg theobromine

  • CF-CaffeineOther

    CF-Caffeine: 587 mg of cocoa flavanols, 112 mg caffeine and <1 mg theobromine

Study groups in NCT03526107
Study groupRoleWhat they receive
CF ControlActive comparatorCF Control: 587 mg of cocoa flavanols (101 mg epicatechin), <1 mg caffeine and <1 mg theobromine
Receives: Other: CF Control
CF-TheobromineExperimentalCF-Theobromine: 575 mg of cocoa flavanols (102 mg epicatechin), 11 mg caffeine and 93 mg theobromine
Receives: Other: CF-Theobromine
CF-CaffeineExperimentalCF-Caffeine: 587 mg of cocoa flavanols (101 mg epicatechin), 112 mg caffeine and <1 mg theobromine(Experimental)
Receives: Other: CF-Caffeine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flavanol metabolites in plasma

    Plasma concentration of flavanol metabolites

    Measured: Before to 6 h post test material intake

  2. Flavanol metabolites in urine

    Amount of flavanols metabolites excreted in urine

    Measured: 12 h before to 24 h post test material intake

Secondary outcomes (2)

  1. Methylxanthines in plasma

    Plasma concentration of methylxanthines and methylxanthine metabolites

    Measured: Before to 6 h post test material intake

  2. Methylxanthines in urine

    Amount of methylxanthines and methylxanthine 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.

  1. First posted16 May 2018
  2. Study start16 Feb 2017
  3. Primary completion31 May 2017
  4. Study completion31 May 2017

Resources

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
Dietary intervention study in healthy young adult males
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03526107
Sponsor's protocol ID
429275-T
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
No: 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 20854838

  • Ottaviani 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 22240152

  • Koster 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 6946775

  • McCullough 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 16794446

  • Heiss 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

  • Ottaviani JI, Fong RY, Borges G, Kimball J, Ensunsa JL, Medici V, Pourshahidi LK, Kane E, Ward K, Durkan R, Dobani S, Lawther R, O'Connor G, Gill CIR, Schroeter H, Crozier A. Flavan-3-ol-methylxanthine interactions: Modulation of flavan-3-ol bioavailability in volunteers with a functional colon and an ileostomy. Free Radic Biol Med. 2023 Feb 20;196:1-8. doi: 10.1016/j.freeradbiomed.2023.01.003. Epub 2023 Jan 5.

    PubMed 36621554

Questions about this trial

What is this clinical trial studying?

A study testing CF-Theobromine and CF-Caffeine 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). 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 NCT03526107, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.

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