Beetroot Juice and Postprandial Vascular Activity

NCT01559441 | Completed

• 1 other identifier: METC 11-3-085
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Keywords

beetroot juice; nitrate; vascular activity; postprandial state

Outcome Measures

Primary Outcomes (1)

• Vascular activity

  Flow-mediated dilation (FMD) of the brachial artery

  Change from baseline at 2 hours after meal consumption

Secondary Outcomes (5)

• Arterial stiffness

  Change from baseline at 3 hours after meal consumption

• Microcirculatory effects

  Change from baseline at 3 hours after meal consumption

• Metabolic risk markers related to the metabolic syndrome

  During 4 hours after meal consumption

• Postprandial lipid metabolism

  During 4 hours after meal consumption

• Postprandial glucose metabolism

  During 4 hours after meal consumption

Study Arms (2)

Beetroot juice

EXPERIMENTAL

Dietary Supplement: Beetroot Juice with oral fat load

Carbohydrate control drink

PLACEBO COMPARATOR

Dietary Supplement: Carbohydrate control drink with oral fat load

Interventions

Beetroot Juice with oral fat load DIETARY_SUPPLEMENT

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

Beetroot juice

Carbohydrate control drink with oral fat load DIETARY_SUPPLEMENT

140 mL (low-nitrate) carbohydrate control drink

Carbohydrate control drink

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ronald P Mensink, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 21, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

NL (1)