Beetroot Juice and Postprandial Vascular Activity

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559441
• Other study ID #: METC 11-3-085
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: July 15, 2013
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Beetroot Juice with oral fat load
140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)
• Carbohydrate control drink with oral fat load
140 mL (low-nitrate) carbohydrate control drink

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular activity	Flow-mediated dilation (FMD) of the brachial artery	Change from baseline at 2 hours after meal consumption	No
Secondary	Arterial stiffness	Pulse wave analysis (PWA) and velocity (PWV)	Change from baseline at 3 hours after meal consumption	No
Secondary	Microcirculatory effects	Retinal imaging	Change from baseline at 3 hours after meal consumption	No
Secondary	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	No
Secondary	Postprandial lipid metabolism		During 4 hours after meal consumption	No
Secondary	Postprandial glucose metabolism		During 4 hours after meal consumption	No