HealthyNCT03587883
Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans
A study testing Cocoa flavanols I and Cocoa flavanols II 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 to investigate the effects of diet supplementation with cocoa flavanols on arterial stiffness in healthy adult human subjects. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cocoa flavanols I and Cocoa flavanols II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 6 Aug 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25-65 years old
- BMI 18.5 - 34.9 kg/m2
- Weight ≥ 110 pounds
- Previously consumed cocoa and peanut products, with no adverse reactions
- Having completed physical exercise similar to 5 MET within the last 2 months without having any physical limitations [e.g. i) Brisk walking (at 4 mph); ii) Mowing lawn; iii) Bicycling-light effort (10 mph) and iv) Playing tennis-doubles.]
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Non-English speaking*
- BMI ≥ 35 kg/m2
Show all 25Show fewer
- More than 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous-intensity aerobic activity weekly and more than two days a week of muscle strengthening activities that work all major muscle groups (CDC recommended physical activity guidelines for adults)
- Allergies to nuts, cocoa and chocolate products
- Active avoidance of coffee and caffeinated soft drinks
- A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
- History of clinically significant depression, anxiety or other psychiatric condition
- History of difficult blood draws
- History of Raynaud's disease
- 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
- Blood Pressure < 100/60 mm Hg, or heart rate < 50 bpm (due to limitations in the assessment of arterial stiffness
- 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 individuals 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
- Cold, flu, or upper respiratory condition at screening
- Currently participating in a clinical or dietary intervention study
- *Non-English speaking volunteers will be excluded for safety reasons, as we do not have staff that can adequately provide interpretation services that can explain and answer questions with regard to study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis
Davis, California, 95616
About this study
A randomized, double-masked and cross-over dietary intervention study to investigate the effects of diet supplementation with cocoa flavanols on arterial stiffness in healthy adult human subjects.
Read the detailed description
Cocoa flavanols (CF) are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. Flavanols encompass a group of different compounds, and the final profile of flavanols in foods will depend on multiple factors including plant origin, time of harvesting, storage, food processing, and cooking techniques. The term "cocoa flavanols" (CF) as used here refers to the particular profile of flavanols and procyanidins naturally found in cocoa beans, and CF mainly consist of the monomeric flavanol (-)-epicatechin and its oligomeric derivatives (procyanidins) containing up to 10 monomer subunits.
Accumulating data resulting from dietary intervention studies suggest that the intake of diets rich in flavanols can exert a beneficial cardiovascular health effect in humans. However, most of these investigations have been conducted with patients with diverse health complications (e.g. hypertension, diabetes and coronary heart disease) rather than healthy subjects. Thus, the interpretation of these data in the context of nutrition, primary prevention, and dietary recommendations is limited. In the current study, the investigators propose to investigate the effects of cocoa flavanol intake on arterial stiffness in a healthy population of adults. The investigators submit that this investigation will provide novel insights into the potential health benefits of dietary flavanols and procyanidins in the context of cardiovascular health in humans. The data resulting from this study will be key to the design of larger scale studies in this context, which are needed to comprehensively study the role of dietary flavanols and procyanidins with regard to potential dietary recommendations and public health.
- Conditions
- Healthy
- Being tested
- Cocoa flavanols I, Control I, Cocoa flavanols II, Control II
- Keywords
- flavanol, cocoa flavanols, arterial stiffness, blood pressure, step test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa flavanols IOther
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.
Control IOther
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
Cocoa flavanols IIOther
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.
Control IIOther
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cocoa Flavanol intervention | Experimental | Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 300 mg of cocoa flavanols per capsule: 900 mg of cocoa flavanols consumed daily for 2 weeks; 2 intervention periods: Cocoa flavanols I and cocoa flavanols II. Receives: Other: Cocoa flavanols I; Other: Cocoa flavanols II |
| Control intervention | Placebo comparator | Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks; 2 intervention periods: control I and control II. Receives: Other: Control I; Other: Control II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual changes in systolic blood pressure (in office)
assessed as systolic blood pressure
Measured: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Individual changes in diastolic blood pressure (in office)
assessed as diastolic blood pressure
Measured: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Individual changes in augmentation index (in office)
assessed as augmentation index
Measured: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Individual changes in central blood pressure (in office)
assessed as central blood pressure
Measured: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Individual changes in blood pressure (at home)
self monitoring blood pressure
Measured: Daily for 2 weeks between 0, 2, 4, 6, 8 and 10 weeks of intervention
Individual changes in pulse wave velocity (in office)
assessed as pulse wave velocity
Measured: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Individual changes in lipid profile
Total cholesterol, LDL, HDL and Triglycerides
Measured: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Secondary outcomes (4)
Individual changes in flavanol metabolites in plasma and urine
flavanol/methylxanthine metabolites in plasma and urine
Measured: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Individual changes in methylxanthine metabolites in plasma and urine
flavanol/methylxanthine metabolites in plasma and urine
Measured: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Individual changes in CMP
comprehensive metabolic panel
Measured: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Individual changes in Step test performance
Volunteers will be asked to step up and down on a platform (7 inches high) at a rate of 23 steps per minute for no more than 3 minutes. Blood pressure will be measured before and after the step test.
Measured: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start23 Mar 2018
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 adults.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 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
- NCT03587883
- Sponsor's protocol ID
- 547762
- Status last verified
- May 2022
- First submitted
- 3 May 2018
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans
- ClinicalTrials.gov ID
- NCT03587883
- Acronym / sponsor ID
- 547762
- Conditions
- Healthy
- Keywords
- flavanol, cocoa flavanols, arterial stiffness, blood pressure, step test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 16 Jul 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.
A randomized, double-masked and cross-over dietary intervention study to investigate the effects of diet supplementation with cocoa flavanols on arterial stiffness in healthy adult human subjects.
Detailed description
Cocoa flavanols (CF) are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. Flavanols encompass a group of different compounds, and the final profile of flavanols in foods will depend on multiple factors including plant origin, time of harvesting, storage, food processing, and cooking techniques. The term "cocoa flavanols" (CF) as used here refers to the particular profile of flavanols and procyanidins naturally found in cocoa beans, and CF mainly consist of the monomeric flavanol (-)-epicatechin and its oligomeric derivatives (procyanidins) containing up to 10 monomer subunits.
Accumulating data resulting from dietary intervention studies suggest that the intake of diets rich in flavanols can exert a beneficial cardiovascular health effect in humans. However, most of these investigations have been conducted with patients with diverse health complications (e.g. hypertension, diabetes and coronary heart disease) rather than healthy subjects. Thus, the interpretation of these data in the context of nutrition, primary prevention, and dietary recommendations is limited. In the current study, the investigators propose to investigate the effects of cocoa flavanol intake on arterial stiffness in a healthy population of adults. The investigators submit that this investigation will provide novel insights into the potential health benefits of dietary flavanols and procyanidins in the context of cardiovascular health in humans. The data resulting from this study will be key to the design of larger scale studies in this context, which are needed to comprehensively study the role of dietary flavanols and procyanidins with regard to potential dietary recommendations and public health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-masked and cross-over dietary intervention study in healthy adults.
| Arm | Type | Receives |
|---|---|---|
| Cocoa Flavanol intervention | Experimental | Other: Cocoa flavanols I, Other: Cocoa flavanols IICapsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 300 mg of cocoa flavanols per capsule: 900 mg of cocoa flavanols consumed daily for 2 weeks; 2 intervention periods: Cocoa flavanols I and cocoa flavanols II. |
| Control intervention | Placebo comparator | Other: Control I, Other: Control IICocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks; 2 intervention periods: control I and control II. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 25-65 years old
- BMI 18.5 - 34.9 kg/m2
- Weight ≥ 110 pounds
- Previously consumed cocoa and peanut products, with no adverse reactions
- Having completed physical exercise similar to 5 MET within the last 2 months without having any physical limitations [e.g. i) Brisk walking (at 4 mph); ii) Mowing lawn; iii) Bicycling-light effort (10 mph) and iv) Playing tennis-doubles.]
Key exclusion criteria (25 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Non-English speaking*
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 |
|---|---|---|
| Cocoa flavanols ICapsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks. | Other | Cocoa Flavanol intervention |
| Control ICocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks. | Other | Control intervention |
| Cocoa flavanols IICapsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks. | Other | Cocoa Flavanol intervention |
| Control IICocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks. | Other | Control intervention |
Primary outcome
Individual changes in systolic blood pressure (in office)
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as systolic blood pressure
Individual changes in diastolic blood pressure (in office)
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as diastolic blood pressure
Individual changes in augmentation index (in office)
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as augmentation index
Individual changes in central blood pressure (in office)
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as central blood pressure
Individual changes in blood pressure (at home)
Time frame: Daily for 2 weeks between 0, 2, 4, 6, 8 and 10 weeks of intervention
self monitoring blood pressure
Individual changes in pulse wave velocity (in office)
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as pulse wave velocity
Individual changes in lipid profile
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Total cholesterol, LDL, HDL and Triglycerides
4 secondary outcomes
Individual changes in flavanol metabolites in plasma and urine
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Individual changes in methylxanthine metabolites in plasma and urine
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Individual changes in CMP
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Individual changes in Step test performance
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following 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 20 May 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.
- Individual participant dataSharing planned: No
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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 Cocoa flavanols I and Cocoa flavanols II 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 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 20 May 2022. 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?
Individual changes in systolic blood pressure (in office) (time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention). The study lists 7 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 NCT03587883, which also lists 1 linked publication.
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 20 May 2022.