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
  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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 15, 2013
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 September 16, 2014