Beetroot Juice and Postprandial Vascular Activity

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01559441
First received: March 12, 2012
Last updated: July 15, 2013
Last verified: July 2013

March 12, 2012
July 15, 2013
March 2012
August 2012   (final data collection date for primary outcome measure)
Vascular activity [ Time Frame: Change from baseline at 2 hours after meal consumption ] [ Designated as safety issue: No ]
Flow-mediated dilation (FMD) of the brachial artery
Vascular activity [ Time Frame: Change from baseline at 3 hours after meal consumption ] [ Designated as safety issue: No ]
Flow-mediated dilation (FMD) of the brachial artery
Complete list of historical versions of study NCT01559441 on ClinicalTrials.gov Archive Site
  • Arterial stiffness [ Time Frame: Change from baseline at 3 hours after meal consumption ] [ Designated as safety issue: No ]
    Pulse wave analysis (PWA) and velocity (PWV)
  • Microcirculatory effects [ Time Frame: Change from baseline at 3 hours after meal consumption ] [ Designated as safety issue: No ]
    Retinal imaging
  • Metabolic risk markers related to the metabolic syndrome [ Time Frame: During 4 hours after meal consumption ] [ Designated as safety issue: No ]
    Changes in biomarkers for low-grade systemic inflammation and endothelial activation.
  • Postprandial lipid metabolism [ Time Frame: During 4 hours after meal consumption ] [ Designated as safety issue: No ]
  • Postprandial glucose metabolism [ Time Frame: During 4 hours after meal consumption ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Beetroot Juice and Postprandial Vascular Activity
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Dyslipidemia
  • Dietary Supplement: Beetroot Juice with oral fat load
    140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)
  • Dietary Supplement: Carbohydrate control drink with oral fat load
    140 mL (low-nitrate) carbohydrate control drink
  • Experimental: Beetroot juice
    Intervention: Dietary Supplement: Beetroot Juice with oral fat load
  • Placebo Comparator: Carbohydrate control drink
    Intervention: Dietary Supplement: Carbohydrate control drink with oral fat load
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01559441
METC 11-3-085
No
Maastricht University Medical Center
Maastricht University Medical Center
Top Institute Food and Nutrition
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
Maastricht University Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP