Beetroot Juice and Postprandial Vascular Activity

NCT ID: NCT01559441

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Beetroot juice

Group Type: EXPERIMENTAL

Beetroot Juice with oral fat load

Intervention Type: DIETARY_SUPPLEMENT

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

Carbohydrate control drink

Group Type: PLACEBO_COMPARATOR

Carbohydrate control drink with oral fat load

Intervention Type: DIETARY_SUPPLEMENT

140 mL (low-nitrate) carbohydrate control drink

Interventions

Beetroot Juice with oral fat load

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

Intervention Type: DIETARY_SUPPLEMENT

Carbohydrate control drink with oral fat load

140 mL (low-nitrate) carbohydrate control drink

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Top Institute Food and Nutrition

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald P Mensink, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

METC 11-3-085

Identifier Type: -

Identifier Source: org_study_id