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CompletedNCT01559441Updated Jul 16, 2013

Beetroot Juice and Postprandial Vascular Activity

An interventional study of Beetroot Juice with oral fat load and Carbohydrate control drink with oral fat load in Dyslipidemia, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-16.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Dyslipidemia

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Keywords

  • beetroot juice
  • nitrate
  • vascular activity
  • postprandial state
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 20 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Beetroot juice

    Dietary Supplement: Beetroot Juice with oral fat load

  • Placebo comparator
    Carbohydrate control drink

    Dietary Supplement: Carbohydrate control drink with oral fat load

Interventions

  • Dietary supplementBeetroot Juice with oral fat load

    140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)

  • Dietary supplementCarbohydrate control drink with oral fat load

    140 mL (low-nitrate) carbohydrate control drink

06

What researchers measure

Primary outcomes

  1. Vascular activity

    Flow-mediated dilation (FMD) of the brachial artery

    Time frame: Change from baseline at 2 hours after meal consumption

Secondary outcomes

  1. Arterial stiffness

    Pulse wave analysis (PWA) and velocity (PWV)

    Time frame: Change from baseline at 3 hours after meal consumption

  2. Microcirculatory effects

    Retinal imaging

    Time frame: Change from baseline at 3 hours after meal consumption

  3. Metabolic risk markers related to the metabolic syndrome

    Changes in biomarkers for low-grade systemic inflammation and endothelial activation.

    Time frame: During 4 hours after meal consumption

  4. Postprandial lipid metabolism

    Time frame: During 4 hours after meal consumption

  5. Postprandial glucose metabolism

    Time frame: During 4 hours after meal consumption

07

Study locations

1 site
  • Maastricht University Medical Center
    Maastricht, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01559441
Lead sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
Responsible party
Sponsor
First posted
Mar 21, 2012
Start date
Mar 2012
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Jul 16, 2013

Study contacts

Ronald P Mensink, PhD
principal investigator · Maastricht University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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