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Beetroot Juice and Postprandial Vascular Activity

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Beetroot Juice with oral fat load
Carbohydrate control drink with oral fat load
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyslipidemia focused on measuring beetroot juice, nitrate, vascular activity, postprandial state

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beetroot juice

Carbohydrate control drink

Arm Description

Outcomes

Primary Outcome Measures

Vascular activity
Flow-mediated dilation (FMD) of the brachial artery

Secondary Outcome Measures

Arterial stiffness
Pulse wave analysis (PWA) and velocity (PWV)
Microcirculatory effects
Retinal imaging
Metabolic risk markers related to the metabolic syndrome
Changes in biomarkers for low-grade systemic inflammation and endothelial activation.
Postprandial lipid metabolism
Postprandial glucose metabolism

Full Information

First Posted
March 12, 2012
Last Updated
July 15, 2013
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01559441
Brief Title
Beetroot Juice and Postprandial Vascular Activity
Official Title
The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
beetroot juice, nitrate, vascular activity, postprandial state

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beetroot juice
Arm Type
Experimental
Arm Title
Carbohydrate control drink
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot Juice with oral fat load
Intervention Description
140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate control drink with oral fat load
Intervention Description
140 mL (low-nitrate) carbohydrate control drink
Primary Outcome Measure Information:
Title
Vascular activity
Description
Flow-mediated dilation (FMD) of the brachial artery
Time Frame
Change from baseline at 2 hours after meal consumption
Secondary Outcome Measure Information:
Title
Arterial stiffness
Description
Pulse wave analysis (PWA) and velocity (PWV)
Time Frame
Change from baseline at 3 hours after meal consumption
Title
Microcirculatory effects
Description
Retinal imaging
Time Frame
Change from baseline at 3 hours after meal consumption
Title
Metabolic risk markers related to the metabolic syndrome
Description
Changes in biomarkers for low-grade systemic inflammation and endothelial activation.
Time Frame
During 4 hours after meal consumption
Title
Postprandial lipid metabolism
Time Frame
During 4 hours after meal consumption
Title
Postprandial glucose metabolism
Time Frame
During 4 hours after meal consumption

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

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Beetroot Juice and Postprandial Vascular Activity

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