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van CCT (UK)

van CCT (UK)

Beetroot Juice and Endothelial function in Men

- candidate number20910
- NTR NumberNTR4900
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-nov-2014
- Secondary IDsNL45250.078.13  
- Public TitleBeetroot Juice and Endothelial function in Men
- Scientific TitleComparison of flow-mediated dilatation with local thermal hyperaemia as a measure of endothelial function
- hypothesis- There is correlation between FMD and LTH.
- Smokers have a lower FMD and LTH response.
- Beetroot juice improves the FMD and PORH response but not the LTH response.
- Healt Condition(s) or Problem(s) studiedEndothelial function
- Inclusion criteriaNon-smokers:
- Healthy Men
- Age between 25-65 years
- Non-smoking for > 5 years
- Body mass index between 18 and 30 kg/m2
- Capable and willing to give informed consent
- General good health, based on medical history and physical examination
- Systolic BP measured on day of the experiment should be < 160 mmHg
- As for the non-smokers
- In addition smoking at least on average 14 cigarettes per day for at least 5 years
- Exclusion criteria- Female subjects
- History of cardiovascular disease
- Use of vasoactive drugs
- Drug or/and alcohol abuse
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-nov-2014
- planned closingdate1-aug-2015
- Target number of participants40
- InterventionsBeetroot juice
- Primary outcomeDegree of correlation between FMD and LTH
- Secondary outcome Involvement of NO in LTH response
Changes in FMD and LTH in response to beetroot juice consumption.
- Timepoints2 research visits with 7 days between visits.
- Trial web site
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESMD, PhD A.H. Meiracker, van den
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Unilever
- Publications
- Brief summaryMeasurement of flow-mediated dilatation of the brachial artery in response to forearm occlusion for 5 min (FMD) using ultrasonography is a well-accepted, but investigator-demanding method, to determine endothelial function. Local thermal hyperaemia of the skin measured with a laser Doppler flow imaginer (LTH) is less demanding and may be a suitable alternative to determine endothelial function at frequent intervals. We want to investigate whether LTH correlates with FMD response in a group of healthy non-smoking and smoking men and to what extent LTH can be inhibited by the nitricoxide synthase (NOS) inhibitor L-NMMA applied locally on the skin. In addition we want to replicate the reported improved FMD response to nitrate-rich beetroot juice and correlate this to the LTH response. Post occlusive reactive hyperaemia (PORH) of the skin is considered to be a measure of microvascular function and is also thought to be correlated to the FMD response. We will also determine the PORH response during this study.
- Main changes (audit trail)
- RECORD11-nov-2014 - 10-jan-2015

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