Clinical trial NCT01559441: Beetroot Juice and Postprandial Vascular Activity
Official title: The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: beetroot juice
nitrate
vascular activity
postprandial state
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2012-03-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Vascular activity
timeFrame: Change from baseline at 2 hours after meal consumption
Secondary outcomes:
measure: Arterial stiffness
timeFrame: Change from baseline at 3 hours after meal consumption
measure: Microcirculatory effects
timeFrame: Change from baseline at 3 hours after meal consumption
measure: Metabolic risk markers related to the metabolic syndrome
timeFrame: During 4 hours after meal consumption
measure: Postprandial lipid metabolism
timeFrame: During 4 hours after meal consumption
measure: Postprandial glucose metabolism
timeFrame: During 4 hours after meal consumption
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, PhD
role: PRINCIPAL_INVESTIGATOR
References: