Beetroot Juice and Postprandial Vascular Activity

Not Applicable

Completed

• Conditions: Dyslipidemia
• Interventions: Dietary Supplement: Beetroot Juice with oral fat load; Dietary Supplement: Carbohydrate control drink with oral fat load

• Registration Number: NCT01559441
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-21
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Beetroot juice	Beetroot Juice with oral fat load	-
Carbohydrate control drink	Carbohydrate control drink with oral fat load	-

Primary Outcome Measures

Name	Time	Method
Vascular activity	Change from baseline at 2 hours after meal consumption	Flow-mediated dilation (FMD) of the brachial artery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands