The effects of beetroot juice on postprandial vascular activity after a high-fat meal in overweight and slightly obese me

Completed

• Conditions: insulin resistance syndrome; Metabolic Syndrome; Syndrome X; 10013317

• Registration Number: NL-OMON37598
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-08-30
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

Healthy overweight and slightly men will be included. Further inclusion criteria are:
- Aged between 18 and 70 years
- Quetelet-index between 28 and 35 kg/m2
- Mean serum triacylglycerol <=1.7 mmol/L

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.
Severe medical conditions are:
a 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.
Foods rich in nitrates are:
beets, celery, radishes, turnips and spinach.
- 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 and for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter is the capacity of vessels to respond to a standardized<br /><br>high-fat meal during the postprandial period as assessed with flow-mediated<br /><br>dilation (FMD) of the brachial artery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are the responsiveness of larger arteries to<br /><br>postprandial lipemia measured by pulse wave analysis (PWA) and pulse wave<br /><br>velocity (PWV). Microcirculatory effects will be visualized by retinal imaging.<br /><br>In plasma, metabolic risk markers related to the metabolic syndrome will be<br /><br>investigated: postprandial concentrations of factors related to low-grade<br /><br>inflammation and endothelial activation, and postprandial lipid and glucose<br /><br>metabolism. Finally, effects on blood pressure and heart rate will be studied.</p><br>