No registrations found.
ID
Source
Brief title
Health condition
gastrointestinal cancer
colorectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study’s 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 outcome
Secondary 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 subject’s age and also their body height
and weight, in order to calculate the subject’s BMI.
Study objective
We 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.
Study design
This 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.
Intervention
Subjects 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.
S.G.J.
van Breda
6200 MD
S.G.J.
van Breda
6200 MD
Inclusion criteria
In 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 criteria
A 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6234 |
| NTR-old | NTR6414 |
| CCMO | NL55247.068.15 |
| OMON | NL-OMON43980 |