Beetroot Juice and Postprandial Vascular Activity

Study Overview
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Brief Summary
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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.

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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Beetroot Juice with oral fat load
* Dietary Supplement: Carbohydrate control drink with oral fat load


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beetroot juice<br> | Dietary Supplement: Beetroot Juice with oral fat load<br>* 140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)<br>|
| Placebo Comparator: Carbohydrate control drink<br> | Dietary Supplement: Carbohydrate control drink with oral fat load<br>* 140 mL (low-nitrate) carbohydrate control drink<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular activity | Flow-mediated dilation (FMD) of the brachial artery | Change from baseline at 2 hours after meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Pulse wave analysis (PWA) and velocity (PWV) | Change from baseline at 3 hours after meal consumption | 
| Microcirculatory effects | Retinal imaging | Change from baseline at 3 hours after meal consumption | 
| Metabolic risk markers related to the metabolic syndrome | Changes in biomarkers for low-grade systemic inflammation and endothelial activation. | During 4 hours after meal consumption | 
| Postprandial lipid metabolism |  | During 4 hours after meal consumption | 
| Postprandial glucose metabolism |  | During 4 hours after meal consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beetroot juice, nitrate, vascular activity, postprandial state