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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: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Dyslipidemia
 Dietary Supplement: Beetroot Juice with oral fat load
Dietary Supplement: Carbohydrate control drink with oral fat load

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beetroot juice Dietary Supplement: Beetroot Juice with oral fat load
140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)
Placebo Comparator: Carbohydrate control drink Dietary Supplement: Carbohydrate control drink with oral fat load
140 mL (low-nitrate) carbohydrate control drink

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559441

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01559441     History of Changes
Other Study ID Numbers: METC 11-3-085
Study First Received: March 12, 2012
Last Updated: August 27, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
beetroot juice
nitrate
vascular activity
postprandial state

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013