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Completed

NCT Number: NCT01559441

Beetroot Juice and Postprandial Vascular Activity

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot Juice with oral fat load

Dietary Supplement

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

Carbohydrate control drink with oral fat load

Dietary Supplement

140 mL (low-nitrate) carbohydrate control drink

Primary outcomes

  1. Vascular activity

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

    Flow-mediated dilation (FMD) of the brachial artery

Secondary outcomes

  1. Arterial stiffness

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

    Pulse wave analysis (PWA) and velocity (PWV)

  2. Microcirculatory effects

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

    Retinal imaging

  3. Metabolic risk markers related to the metabolic syndrome

    Time frame: During 4 hours after meal consumption

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

  4. Postprandial lipid metabolism

    Time frame: During 4 hours after meal consumption

  5. Postprandial glucose metabolism

    Time frame: During 4 hours after meal consumption

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 21, 2012
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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