Endothelial DysfunctionCHOCNCT01308892
Cardiovascular Health Effects of Flavanol Rich Chocolate
A study testing High flavanol chocolate, Low flavanol chocolate and High fat challenge in people with Endothelial Dysfunction, run by Wageningen University at 1 site in Netherlands.
Trial summary
In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- High flavanol chocolate, Low flavanol chocolate and High fat challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jun 2011
- 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 45 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 45-70 years old
- BMI between 25 and 32 kg/m2
Who cannot join
- Urine glucose concentrations outside normal ranges (> 0,25 g/l)
- Fasting blood glucose < 7.0 mmol/L)
- Systolic Bp > 160 mmHg or diastolic Bp > 100 mmHg
- Blood Hb values below 8.4 mmol/L
- Allergic to cow milk, dairy products or chocolate
- Vegetarian
- Tobacco smoker
- Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen universiteit division of human
Wageningen, Gelderland, 6703HD
About this study
In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.
- Conditions
- Endothelial Dysfunction
- Being tested
- High flavanol chocolate, Low flavanol chocolate, High fat challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flavanol chocolateDietary supplement
chocolate high in flavanols
Low flavanol chocolateDietary supplement
chocolate low in flavanols
High fat challengeDietary supplement
Milkshake with 95g fat
| Study group | Role | What they receive |
|---|---|---|
| High flavaonol chocolate | Active comparator | Not described Receives: Dietary Supplement: High flavanol chocolate; Dietary Supplement: High fat challenge |
| Low flavanol chocolate | Placebo comparator | Not described Receives: Dietary Supplement: Low flavanol chocolate; Dietary Supplement: High fat challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 0, 4wk
FMD
Measured: 0, 4wk
PWA
Measured: 0, 4wk
Secondary outcomes (9)
leukocyte count and activation
Measured: 0, 4wk
PBMC gene expression
Measured: 0, 4wk
Markers of inflammation and ED
Measured: 0, 4wk
Blood pressure
acute study part
Measured: 0 and 2h
FMD
acute study part
Measured: 0 and 2hrs
PWA
acute study part
Measured: 0 and 2 hrs
Leukocyte count and activation
acute study part
Measured: 0 and 2 hrs
PBMC gene expression
acute study part
Measured: 0 and 2 hrs
markers of inflammation and ED
acute study part
Measured: 0 and 2hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Investigators
- Michael Müller, Prof.Dr, Study chair, Chair Department of human nutrition NMG group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308892
- Sponsor's protocol ID
- NL33506.081.10
- Acronym
- CHOC
- Status last verified
- Jun 2011
- First submitted
- 15 Feb 2011
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Effects of Flavanol Rich Chocolate
- ClinicalTrials.gov ID
- NCT01308892
- Acronym / sponsor ID
- CHOC / NL33506.081.10
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flavaonol chocolate | Active comparator | Dietary Supplement: High flavanol chocolate, Dietary Supplement: High fat challenge |
| Low flavanol chocolate | Placebo comparator | Dietary Supplement: Low flavanol chocolate, Dietary Supplement: High fat challenge |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- 45-70 years old
- BMI between 25 and 32 kg/m2
Key exclusion criteria (8 listed)
- Urine glucose concentrations outside normal ranges (> 0,25 g/l)
- Fasting blood glucose < 7.0 mmol/L)
- Systolic Bp > 160 mmHg or diastolic Bp > 100 mmHg
- Blood Hb values below 8.4 mmol/L
- Allergic to cow milk, dairy products or chocolate
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 |
|---|---|---|
| High flavanol chocolatechocolate high in flavanols | Dietary supplement | High flavaonol chocolate |
| Low flavanol chocolatechocolate low in flavanols | Dietary supplement | Low flavanol chocolate |
| High fat challengeMilkshake with 95g fat | Dietary supplement | High flavaonol chocolate, Low flavanol chocolate |
Primary outcome
Blood pressure
Time frame: 0, 4wk
FMD
Time frame: 0, 4wk
PWA
Time frame: 0, 4wk
9 secondary outcomes
leukocyte count and activation
Time frame: 0, 4wk
PBMC gene expression
Time frame: 0, 4wk
Markers of inflammation and ED
Time frame: 0, 4wk
Blood pressure
Time frame: 0 and 2h
FMD
Time frame: 0 and 2hrs
PWA
Time frame: 0 and 2 hrs
Leukocyte count and activation
Time frame: 0 and 2 hrs
PBMC gene expression
Time frame: 0 and 2 hrs
markers of inflammation and ED
Time frame: 0 and 2hrs
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 17 Jun 2011.
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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.
Michael Müller, Prof.Dr study chair
Chair Department of human nutrition NMG group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flavanol chocolate, Low flavanol chocolate and High fat challenge in people with Endothelial Dysfunction, run by Wageningen University at 1 site in Netherlands.
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 3 inclusion and 8 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 17 Jun 2011. 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 Netherlands. 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?
Blood pressure (time frame: 0, 4wk). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2011.