Cardiovascular DiseasesNCT01481389
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
A study testing Theobromine, Cocoa and Cocoa and theobromine in people with Cardiovascular Diseases, run by Unilever R&D at 1 site in France.
Trial summary
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Theobromine, Cocoa and Cocoa and theobromine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Jan 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
- Willing and able to participate in the study protocol
- Written informed consent
- Age 40-70 years
- 10-year risk of developing CHD <10%, based on data from the Framingham Heart Study
- BMI > 18 and < 30 kg/m2
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- Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
- Willing to comply with the dietary restrictions of the study.
- Accessible veins on arm(s) as determined by examination at screening
Who cannot join
- Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- Diabetes mellitus
- Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male)
- Currently on a medically prescribed diet, or slimming diet
- Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
- Reported intense sporting activities > 10 h/w
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- Use of prescribed medication which may interfere with study measurements, as judged by the physician
- Use of antibiotics in the three months before screening or during the study.
- Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
- Reported intolerance to test products or other food products provided during the study
- Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
- Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
- Extreme coffee consumption
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.
Hypothesis: theobromine has a positive effect on blood lipid parameters.
- Conditions
- Cardiovascular Diseases
- Being tested
- Theobromine, Cocoa, Cocoa and theobromine, Placebo
- Keywords
- Blood lipids, risk factor for cardiovascular diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheobromineDietary supplement
200 ml drink with added theobromine (no cocoa added)
CocoaDietary supplement
200 ml drink with cocoa (no theobromine added)
Cocoa and theobromineDietary supplement
200 ml drink with added cocoa and theobromine
PlaceboDietary supplement
200 ml drink (no added theobromine or cocoa)
| Study group | Role | What they receive |
|---|---|---|
| Theobromine drink | Active comparator | Not described Receives: Dietary Supplement: Theobromine |
| Cocoa drink | Active comparator | Not described Receives: Dietary Supplement: Cocoa |
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Cocoa and theobromine drink | Active comparator | Not described Receives: Dietary Supplement: Cocoa and theobromine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipids
Measured: after 4 weeks intervention
Secondary outcomes (2)
Blood pressure
Measured: After 4 weeks intervention
Heart rate
Measured: After 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2011
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 Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wieneke Koppenol, MSc, Study director, Unilever R&DNicole Neufingerl, MSc, Study director, Unilever R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481389
- Sponsor's protocol ID
- 10022V
- Status last verified
- Sep 2012
- First submitted
- 22 Nov 2011
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Neufingerl N, Zebregs YE, Schuring EA, Trautwein EA. Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2013 Jun;97(6):1201-9. doi: 10.3945/ajcn.112.047373. Epub 2013 Apr 17.
PubMed 23595874
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01481389
- Acronym / sponsor ID
- 10022V
- Conditions
- Cardiovascular Diseases
- Keywords
- Blood lipids, risk factor for cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- First posted
- 29 Nov 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.
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.
Hypothesis: theobromine has a positive effect on blood lipid parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Theobromine drink | Active comparator | Dietary Supplement: Theobromine |
| Cocoa drink | Active comparator | Dietary Supplement: Cocoa |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo |
| Cocoa and theobromine drink | Active comparator | Dietary Supplement: Cocoa and theobromine |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
- Willing and able to participate in the study protocol
- Written informed consent
- Age 40-70 years
- 10-year risk of developing CHD <10%, based on data from the Framingham Heart Study
Key exclusion criteria (13 listed)
- Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- Diabetes mellitus
- Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male)
- Currently on a medically prescribed diet, or slimming diet
- Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
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 |
|---|---|---|
| Theobromine200 ml drink with added theobromine (no cocoa added) | Dietary supplement | Theobromine drink |
| Cocoa200 ml drink with cocoa (no theobromine added) | Dietary supplement | Cocoa drink |
| Cocoa and theobromine200 ml drink with added cocoa and theobromine | Dietary supplement | Cocoa and theobromine drink |
| Placebo200 ml drink (no added theobromine or cocoa) | Dietary supplement | Placebo drink |
Primary outcome
Blood lipids
Time frame: after 4 weeks intervention
2 secondary outcomes
Blood pressure
Time frame: After 4 weeks intervention
Heart rate
Time frame: After 4 weeks 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 18 Sep 2012.
- Derived from this study: PubMed 23595874Neufingerl N, Zebregs YE, Schuring EA, Trautwein EA. Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2013 Jun;97(6):1201-9. doi: 10.3945/ajcn.112.047373. Epub 2013 Apr 17.
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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.
Wieneke Koppenol, MSc study director
Unilever R&D
Nicole Neufingerl, MSc study director
Unilever R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theobromine, Cocoa and Cocoa and theobromine in people with Cardiovascular Diseases, run by Unilever R&D at 1 site in France.
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 9 inclusion and 13 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 18 Sep 2012. 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 France. 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 lipids (time frame: after 4 weeks intervention). 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 NCT01481389, 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 18 Sep 2012.