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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05710341
Registration number
NCT05710341
Ethics application status
Date submitted
24/01/2023
Date registered
2/02/2023
Date last updated
13/09/2023
Titles & IDs
Public title
Nitrate INFORMER Water Study
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Scientific title
Randomised Controlled Trial to Investigate N-nitrosamine Formation After Water Intake
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Secondary ID [1]
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2022-03891-BONDONNO
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Health Risk Behaviors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Water with added nitrate
Other interventions - Water without added nitrate
Active Comparator: Water with added nitrate - 137 mg sodium nitrate or 164 mg potassium nitrate (100mg of nitrate) in a 500 mL water bottle (200 mg/L) provided twice, one with breakfast and one with lunch. This is equivalent to 200mg nitrate in total.
Placebo Comparator: Water without added nitrate - 137 mg sodium chloride or 164 mg potassium chloride in a 500 mL water bottle provided twice, one with breakfast and one with lunch.
Other interventions: Water with added nitrate
Water with added nitrate
Other interventions: Water without added nitrate
Water without added nitrate
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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N-nitrosamines in urine post intervention (up to 24 hours)
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Assessment method [1]
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Participants will be provided with sterilized containers and instructions to collect all urine until 24 hours post intervention. Urine aliquots will be frozen at -80°C until analysis. N-nitrosamines will be measured by gas chromatography mass spectrometry (GCMS).
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Timepoint [1]
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At each clinic visit, all urine from the start of intervention up till 24 hours will be collected.
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Primary outcome [2]
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N-nitrosamines in stool samples post intervention (up to 24 hours)
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Assessment method [2]
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Participants will be provided with instructions and a stool sample collection pack (collection bags, cable ties, large zip lock bags, freezer ice blocks and a designated cooler bag for transport). Collected stool samples will be weighed and frozen at -80°C until analysis. N-nitrosamines will be measured by gas chromatography mass spectrometry (GCMS).
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Timepoint [2]
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At each clinic visit, all stool samples from the start of intervention up till 24 hours will be collected.
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Eligibility
Key inclusion criteria
The recruitment will be as inclusive as possible so that the results are relevant to much
of the general population. Twenty-five men and women will be recruited from the Perth
general population according to the following criteria:
- aged between 18 to 70 years old
- healthy, ambulant, community-dwelling
- with no history of major chronic disease
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Individuals volunteering to participate in the study will be excluded according to the
following criteria:
- current or recent (<12 months) smoking
- body mass index (BMI) <18 or > 35 kg/m2
- systolic blood pressure > 160 mmHg
- diastolic blood pressure > 100 mmHg
- any major illness such as cancer, psychiatric illness, diagnosed diabetes
- use of any of the following medications: statins, antihypertensives, nitric oxide
donors, antithrombotic medication, anti-coagulant medication, anti-arrhythmic drugs,
beta-blockers, regular aspirin use, regular proton pump inhibitor use
- alcohol consumption > 30g/day
- who are pregnant, lactating, or wishing to become pregnant during the study
- use of antibiotics within the previous 12 weeks of the study
- regular use of mouthwash and not willing to cease mouthwash use for the duration of
the study participation on other research studies
- major gastrointestinal tract condition e.g. Crohns disease and inflammatory bowel
disease and inability or unwillingness to follow the study protocol.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/05/2023
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Royal Perth Hospital Research Foundation - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Edith Cowan University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of Western Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Flinders University
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Nitrate is a controversial component of vegetables, meat, and drinking water. The now
well-established benefits of nitrate, through the enterosalivary nitrate-nitrite-nitric oxide
(NO) pathway, on cardiovascular risk factors and long-term cardiovascular disease risk are
tarnished by a continuing concern about a link between nitrate ingestion and cancer. This can
result in misguided advice to avoid consumption of high-nitrate leafy green vegetables by
both the media and the scientific literature. A recent media headline stated, "Cancer alert
over rocket: trendy salad leaves exceed safe levels of carcinogenic nitrates in one in every
ten samples". One scientific review stated, "the presence of nitrate in vegetables, as in
water and generally in other foods, is a serious threat to man's health". Controversy in the
literature, and gaps in the knowledge are leading to confusing messages around vegetables
that may play a critical role in cardiovascular health.
The major dietary sources of nitrate are vegetables, meat, and drinking water. Source of
nitrate could be a crucial factor determining whether the consumption of nitrate is linked
with beneficial (such as improving cardiovascular health) versus harmful (N-nitrosamine
formation) effects. For example, unlike meat and water-derived nitrate, vegetables contain
high levels of vitamin C and/or polyphenols that may inhibit the production of
N-nitrosamines. So far, no study has investigated the formation of N-nitrosamines after
consumption of these different sources in humans. This study will compare N-nitrosamine
formation after intake of water with and without added nitrate.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05710341
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Catherine Bondonno, PhD
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Address
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Edith Cowan University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05710341
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