DyslipidemiaNCT01559441
Beetroot Juice and Postprandial Vascular Activity
A study testing Beetroot Juice with oral fat load in people with Dyslipidemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Increased postprandial lipemia may increase the risk for cardiovascular diseases. An important mechanistic link between lipemia following a high-fat meal and adverse cardiovascular events is lipid-mediated endothelial activation. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Beetroot Juice with oral fat load
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Aug 2012
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years
- Quetelet-index between 28-35 kg/m2
- Mean serum triacylglycerol ≤1.7 mmol/L
- No indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- No current smoker
- No diabetic patients or individuals receiving antidiabetic medication
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- No familial hypercholesterolemia
- No abuse of drugs
- Less than 21 alcoholic consumptions per week
- Stable body weight (weight gain or loss <3 kg in the past three months)
- No use of medication known to affect serum lipid metabolism
- No severe medical conditions that might interfere with the study, such as high blood pressure, epilepsy, asthma, allergies, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- Willingness to stop the consumption of foods rich in nitrates 3 weeks before the start of the study. Vegetables such as beets, celery, radishes, turnips and spinach are rich in nitrates
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visits
Who cannot join
- Women
- Quetelet-index between <28 or >35 kg/m2
- Mean serum triacylglycerol ≥1.7 mmol/L
- Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- Current smoker
- Diabetic patients or individuals receiving antidiabetic medication
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- Familial hypercholesterolemia
- Abuse of drugs
- More than 21 alcoholic consumptions per week
- Unstable body weight (weight gain or loss >3 kg in the past three months)
- Use of use of medication known to affect serum lipid metabolism
- No severe medical conditions that might interfere with the study, such as high blood pressure, epilepsy, asthma, allergies, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- Use of an investigational product within the previous 1 month
- Not willing to stop the consumption of foods rich in nitrates 3 weeks before the start of the study
- Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men
Increased postprandial lipemia may increase the risk for cardiovascular diseases. An important mechanistic link between lipemia following a high-fat meal and adverse cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important to identify nutrients that can neutralize this acute vascular disturbance.
The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could improve vascular activity during the postprandial phase.
- Conditions
- Dyslipidemia
- Being tested
- Beetroot Juice with oral fat load, Carbohydrate control drink with oral fat load
- Keywords
- beetroot juice, nitrate, vascular activity, postprandial state
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot Juice with oral fat loadDietary supplement
140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)
Carbohydrate control drink with oral fat loadDietary supplement
140 mL (low-nitrate) carbohydrate control drink
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Experimental | Not described Receives: Dietary Supplement: Beetroot Juice with oral fat load |
| Carbohydrate control drink | Placebo comparator | Not described Receives: Dietary Supplement: Carbohydrate control drink with oral fat load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular activity
Flow-mediated dilation (FMD) of the brachial artery
Measured: Change from baseline at 2 hours after meal consumption
Secondary outcomes (5)
Arterial stiffness
Pulse wave analysis (PWA) and velocity (PWV)
Measured: Change from baseline at 3 hours after meal consumption
Microcirculatory effects
Retinal imaging
Measured: Change from baseline at 3 hours after meal consumption
Metabolic risk markers related to the metabolic syndrome
Changes in biomarkers for low-grade systemic inflammation and endothelial activation.
Measured: During 4 hours after meal consumption
Postprandial lipid metabolism
Measured: During 4 hours after meal consumption
Postprandial glucose metabolism
Measured: During 4 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559441
- Sponsor's protocol ID
- METC 11-3-085
- Status last verified
- Jul 2013
- First submitted
- 12 Mar 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men
- ClinicalTrials.gov ID
- NCT01559441
- Acronym / sponsor ID
- METC 11-3-085
- Conditions
- Dyslipidemia
- Keywords
- beetroot juice, nitrate, vascular activity, postprandial state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Mar 2012 (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.
Increased postprandial lipemia may increase the risk for cardiovascular diseases. An important mechanistic link between lipemia following a high-fat meal and adverse cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important to identify nutrients that can neutralize this acute vascular disturbance.
The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could improve vascular activity during the postprandial phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Experimental | Dietary Supplement: Beetroot Juice with oral fat load |
| Carbohydrate control drink | Placebo comparator | Dietary Supplement: Carbohydrate control drink with oral fat load |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged between 18 and 70 years
- Quetelet-index between 28-35 kg/m2
- Mean serum triacylglycerol ≤1.7 mmol/L
- No indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- No current smoker
Key exclusion criteria (17 listed)
- Women
- Quetelet-index between <28 or >35 kg/m2
- Mean serum triacylglycerol ≥1.7 mmol/L
- Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- Current smoker
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 |
|---|---|---|
| Beetroot Juice with oral fat load140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd) | Dietary supplement | Beetroot juice |
| Carbohydrate control drink with oral fat load140 mL (low-nitrate) carbohydrate control drink | Dietary supplement | Carbohydrate control drink |
Primary outcome
Vascular activity
Time frame: Change from baseline at 2 hours after meal consumption
Flow-mediated dilation (FMD) of the brachial artery
5 secondary outcomes
Arterial stiffness
Time frame: Change from baseline at 3 hours after meal consumption
Microcirculatory effects
Time frame: Change from baseline at 3 hours after meal consumption
Metabolic risk markers related to the metabolic syndrome
Time frame: During 4 hours after meal consumption
Postprandial lipid metabolism
Time frame: During 4 hours after meal consumption
Postprandial glucose metabolism
Time frame: During 4 hours after meal consumption
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 16 Jul 2013.
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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.
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Juice with oral fat load in people with Dyslipidemia, 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 16 inclusion and 17 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 16 Jul 2013. 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?
Vascular activity (time frame: Change from baseline at 2 hours after meal consumption). 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 16 Jul 2013.