Beetroot Juice and Postprandial Vascular Activity

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: Beetroot Juice with oral fat load; Dietary supplement: Carbohydrate control drink with oral fat load

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Top Institute Food and Nutrition

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Estimate): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 15, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: nitrate; beetroot juice; postprandial state; vascular activity
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: METC 11-3-085