Cardiovascular DiseasesNCT02085109
The Effects of Fat and Theobromine on apoA-I
A study testing Fat milkshake and Theobromine in people with Cardiovascular Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still present. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Fat milkshake and Theobromine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2014to Jul 2014
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 60 years
- Serum total cholesterol <8.0 mmol/L
- Plasma glucose <7.0 mmol/L
- BMI between 20 - 30 kg/m2
- Non-smoking
- Willingness to abstain from theobromine rich products from two weeks prior to the study maintaining throughout the full duration (17 days) of the study:
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- Chocolate containing products (see Appendix A).
- Willingness to abstain from energy drinks from two weeks prior to the study maintaining throughout the full duration (17 days) of the study, because of its high caffeine content,
- Willingness to reduce caffeine containing drinks till maximum 4 drinks a day from two weeks prior to the study maintaining throughout the full duration (17 days) of the study:
- Coffee
- Tea
- Cola.
Who cannot join
- Unstable body weight (weight gain or loss >3 kg in the past 3 months),
- Not willing to stop the consumption of gastric acid inhibitor, laxantia, prebiotics, probiotics and antibiotics for at least one month before the start of the study and during the study.
- Any medical condition requiring treatment and/or medication use,
- Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (35)
- Use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism. The use of oral contraceptives and paracetamol is allowed.
- Active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident.
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- Gastrointestinal diseases (like celiac disease, inflammatory bowel disease, irritable bowel disease and food allergies) or a history of any gastrointestinal disorders or complaints.
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease and rheumatoid arthritis.
- Not willing to stop the consumption of vitamin supplements or fish oil capsules 3 weeks before the start of the study
- Consumption of >21 glasses of alcohol-containing drinks per week.
- Abuse of drugs
- Participation in another biomedical study within 1 month prior to the screening visit
- Having donated > 150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study.
- Impossible or difficult to puncture as evidenced during the screening visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Diet Rich in Fat or Theobromine on Intestinal apoA-I mRNA and Protein Expression
Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still present. An additive strategy to further lower this residual risk may be via raising high-density lipoprotein (HDL) cholesterol concentrations, and in particular those of its major protein constituent apolipoprotein A-I (apoA-I). However, recent evidence shows that raising HDL cholesterol (HDL-C) concentrations not always causes a reduction in cardiovascular disease (CVD) risk. To understand this it is important to know what are the targets and molecular mechanisms that underlie a shift to a HDL fraction with cardioprotective activities. There is increasing evidence that particularly the apoA-I proteins in the HDL fractions are atheroprotective. It is important to verify whether the effect of an intervention actually increases apoA-I production since that results in the formation of de-novo small pre-beta HDL particles that have full capacity to resorb cholesterol from the arterial wall and return this to the liver for secretion (reverse cholesterol transport). The investigators here propose to evaluate, in a double-blind human intervention study, the difference in intestinal apoA-I gene expression, of healthy subjects, after consumption of a high fat (HF) or low fat (LF) meal. Additionally the investigators propose to evaluate the effect of theobromine on intestinal apoA-I expression. Based on several studies, theobromine improved cardiovascular risk parameters among which an elevation in apoA-I and HDL cholesterol concentrations. It is however unknown whether this effect of theobromine originates from elevated apoA-I production, which suggest improved functionality, or decreased clearance, suggesting reduced functionality. The investigators therefore propose to also evaluate if the usage of theobromine is a better way to increase intestinal apoA-I mRNA and protein expression, than consumption of a HF meal. The investigators will do this in the same double-blind human intervention study. The theobromine will be added in a third arm in a LF condition.
Study design: The proposed study will have a randomized, double-blind cross-over design. The total study duration will be 17 days, consisting of 3 experimental days with postprandial tests, each separated by a 1 week wash-out period.
Read more
Study population: Ten apparently healthy male subjects, aged 18-60 years, without a history of any gastrointestinal disorders or complaints.
Intervention: During the three experimental days, subjects will consume a milkshake: one HF milkshake, one LF milkshake and one LF milkshake supplemented with 850 mg theobromine. Total follow-up during each of the postprandial tests is 5 hours.
- Conditions
- Cardiovascular Diseases
- Being tested
- Fat milkshake, Theobromine
- Keywords
- Cardiovascular Diseases, HDL metabolism, ApoA-I, High fat, Theobromine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat milkshakeDietary supplement
TheobromineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High fat meal | Experimental | A high fat milkshake containing 60.6 grams of fat Receives: Dietary Supplement: Fat milkshake |
| Low fat meal | Placebo comparator | A Low fat milkshake containing 10.5 gram of fat Receives: Dietary Supplement: Fat milkshake |
| A Low fat meal containing theobromine | Experimental | A low fat milkshake containing 10.5 grams of fat supplemented with 850 mg of theobromine Receives: Dietary Supplement: Fat milkshake; Dietary Supplement: Theobromine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microarray
On each 3 test days 5 hours after the postprandial meal a biopsy will be taken. From these intestinal cells gene expression profiles will be measured by microarray.
Measured: up to 3 days
Secondary outcomes (1)
Blood samples
During each test day blood samples will be taken in intervals after consumption of the postprandial meal. Blood samples are taken to analyse lipids, apoA-I, apoB-100, apoB48, CRP, cholesterol efflux, glucose and free fatty acids.
Measured: Day 1, 2 and 3 at T=0, 15, 30, 45, 60, 90, 120, 180 and 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Prof, Principal investigator, Maastricht University HospitalRonald Mensink, Prof, Study director, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085109
- Sponsor's protocol ID
- METC 13-3-049
- Status last verified
- Aug 2014
- First submitted
- 17 Feb 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Diet Rich in Fat or Theobromine on Intestinal apoA-I mRNA and Protein Expression
- ClinicalTrials.gov ID
- NCT02085109
- Acronym / sponsor ID
- METC 13-3-049
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, HDL metabolism, ApoA-I, High fat, Theobromine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Mar 2014 (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.
Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still present. An additive strategy to further lower this residual risk may be via raising high-density lipoprotein (HDL) cholesterol concentrations, and in particular those of its major protein constituent apolipoprotein A-I (apoA-I). However, recent evidence shows that raising HDL cholesterol (HDL-C) concentrations not always causes a reduction in cardiovascular disease (CVD) risk. To understand this it is important to know what are the targets and molecular mechanisms that underlie a shift to a HDL fraction with cardioprotective activities. There is increasing evidence that particularly the apoA-I proteins in the HDL fractions are atheroprotective. It is important to verify whether the effect of an intervention actually increases apoA-I production since that results in the formation of de-novo small pre-beta HDL particles that have full capacity to resorb cholesterol from the arterial wall and return this to the liver for secretion (reverse cholesterol transport). The investigators here propose to evaluate, in a double-blind human intervention study, the difference in intestinal apoA-I gene expression, of healthy subjects, after consumption of a high fat (HF) or low fat (LF) meal. Additionally the investigators propose to evaluate the effect of theobromine on intestinal apoA-I expression. Based on several studies, theobromine improved cardiovascular risk parameters among which an elevation in apoA-I and HDL cholesterol concentrations. It is however unknown whether this effect of theobromine originates from elevated apoA-I production, which suggest improved functionality, or decreased clearance, suggesting reduced functionality. The investigators therefore propose to also evaluate if the usage of theobromine is a better way to increase intestinal apoA-I mRNA and protein expression, than consumption of a HF meal. The investigators will do this in the same double-blind human intervention study. The theobromine will be added in a third arm in a LF condition.
Study design: The proposed study will have a randomized, double-blind cross-over design. The total study duration will be 17 days, consisting of 3 experimental days with postprandial tests, each separated by a 1 week wash-out period.
Study population: Ten apparently healthy male subjects, aged 18-60 years, without a history of any gastrointestinal disorders or complaints.
Intervention: During the three experimental days, subjects will consume a milkshake: one HF milkshake, one LF milkshake and one LF milkshake supplemented with 850 mg theobromine. Total follow-up during each of the postprandial tests is 5 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High fat meal | Experimental | Dietary Supplement: Fat milkshakeA high fat milkshake containing 60.6 grams of fat |
| Low fat meal | Placebo comparator | Dietary Supplement: Fat milkshakeA Low fat milkshake containing 10.5 gram of fat |
| A Low fat meal containing theobromine | Experimental | Dietary Supplement: Fat milkshake, Dietary Supplement: TheobromineA low fat milkshake containing 10.5 grams of fat supplemented with 850 mg of theobromine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Aged between 18 and 60 years
- Serum total cholesterol <8.0 mmol/L
- Plasma glucose <7.0 mmol/L
- BMI between 20 - 30 kg/m2
- Non-smoking
Key exclusion criteria (14 listed)
- Unstable body weight (weight gain or loss >3 kg in the past 3 months),
- Not willing to stop the consumption of gastric acid inhibitor, laxantia, prebiotics, probiotics and antibiotics for at least one month before the start of the study and during the study.
- Any medical condition requiring treatment and/or medication use,
- Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (35)
- Use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism. The use of oral contraceptives and paracetamol is allowed.
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 |
|---|---|---|
| Fat milkshake | Dietary supplement | A Low fat meal containing theobromine, High fat meal, Low fat meal |
| Theobromine | Dietary supplement | A Low fat meal containing theobromine |
Primary outcome
Microarray
Time frame: up to 3 days
On each 3 test days 5 hours after the postprandial meal a biopsy will be taken. From these intestinal cells gene expression profiles will be measured by microarray.
1 secondary outcome
Blood samples
Time frame: Day 1, 2 and 3 at T=0, 15, 30, 45, 60, 90, 120, 180 and 240 min
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 5 Aug 2014.
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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.
Jogchum Plat, Prof principal investigator
Maastricht University Hospital
Ronald Mensink, Prof study director
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat milkshake and Theobromine in people with Cardiovascular Diseases, run by Maastricht University Medical Center 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 12 inclusion and 14 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 5 Aug 2014. 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?
Microarray (time frame: up to 3 days). 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 5 Aug 2014.