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van CCT (UK)

van CCT (UK)

Het effect van geconcentreerd bietensap met of zonder vitamine C op de concentratie van Nnitroso verbindingen in urine

- candidate number27121
- NTR NumberNTR6414
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-apr-2017
- Secondary IDsNL55247.068.15 / METC 153054 Medisch Ethische Toetsings Commissie azM/UM
- Public TitleHet effect van geconcentreerd bietensap met of zonder vitamine C op de concentratie van Nnitroso verbindingen in urine
- Scientific TitleThe effect of concentrated beetroot juice with or without vitamin C on the levels of N-nitroso compounds in urine
- ACRONYMKnocking down NOCs
- hypothesisWe hypothesize that consumption of 70 mL of concentrated red beetroot juice will result in a significant increase in urinary NOC levels, and that the same amount of beetroot juice in combination with 1 g vitamin C will result in a decrease in urinary NOC levels. Furthermore, we hypothesize that either the increase or the decrease in urinary NOC levels is greater after one week of consumption, compared with a one-time consumption.
- Healt Condition(s) or Problem(s) studiedGastro intestinal cancer, Colorectal cancer
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Healthy
- 18 - 45 years of age
- 18,5 < BMI < 30 kg/m2
- Regular physical activity (minimum of 1 hour and maximum of 8 hours a week)
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- Use of medication
- Smoking
- Currently supplementing diet with vitamin C
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-mrt-2017
- planned closingdate
- Target number of participants30
- InterventionsSubjects will be instructed to consume 70 ml of concentrated red beetroot juice (400 mg nitrate) or the same amount of beetroot juice in combination with 1 g Vitamin C for seven days.
- Primary outcomeThe studyís main parameter is the total NOC concentration in each individual sample of morning urine. The goal is to detect whether the consumption of BRJ, after a period of loading, will result in an increase of the concentration NOC and whether the administration of vitamin C will have an effect on this outcome. The concentration will be measured with the use of the chemiluminescence method
- Secondary outcomeSecondary study parameters are urine nitrate and nitrite concentration. These concentrations will be measured with the High Performance Liquid Chromatography method. Furthermore, the resting blood pressure of each subject will be measured. This is done with the use of blood pressure monitors (Welch Allyn 767 Desk Aneroid with an adult cuff). Additionally, creatinine levels in the urine will be measure, to be able to standardise the NOCformation found in the urine.
Other baseline values that will be recorded are the subjectís age and also their body height and weight, in order to calculate the subjectís BMI.
- TimepointsThis protocol includes 8 days in which urine will be collected after consumption of red beetroot juice with or without Vitamin C. Consumption of red beetroot juice with or without Vitamin C depends where the research group subjects are allocated to. On day one, morning urine will be collected at baseline, which means before beverage ingestion. Day 1 to 8 in the evening, subjects will consume red beetroot juice with or without Vitamin C in the evening. Morning urine will also be collected on day 2 and 8, which is after one day and one week of consumption, respectively.
On day 1 and 8, subjects have to come to the laboratory in the morning for assessment of resting blood pressure.
- Trial web site
- status[default]
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD21-apr-2017 - 25-jun-2017

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