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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/NCT05045807




Registration number
NCT05045807
Ethics application status
Date submitted
30/08/2021
Date registered
16/09/2021
Date last updated
1/04/2022

Titles & IDs
Public title
Nitrate INFORMER Nitrosamine Study
Scientific title
Randomised Controlled Trial to Investigate N-nitrosamine Formation After Meat Intake - Pilot Study of the Nitrate INFORMER Studies; Nitrate INFORMER Studies: Is Nitrosamine FORMation dEpenent on souRce
Secondary ID [1] 0 0
2021-02629-BONDONNO(pilot)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Risk Behaviors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Meat with added nitrate
Other interventions - Meat with added nitrate plus vegetables

Experimental: Meat with added nitrate - Prosciutto/pancetta/Parma ham/salami (all derived from pork) prepared by a commercial butcher with sodium nitrate as an additive.

Experimental: Meat with added nitrate plus vegetables - The same intervention as of Arm "meat with added nitrate" consumed together with mixed vegetables.


Other interventions: Meat with added nitrate
Prosciutto/pancetta/Parma ham/salami (all derived from pork) prepared by a commercial butcher with the sodium nitrate and nitrite as an additive.

Other interventions: Meat with added nitrate plus vegetables
The same intervention as of intervention "meat with added nitrate" consumed together with mixed vegetables.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
N-nitrosamines in urine pre each intervention
Timepoint [1] 0 0
At each clinic visit, baseline samples of urine will be collected.
Primary outcome [2] 0 0
N-nitrosamines in urine post each intervention up to 240 min
Timepoint [2] 0 0
At each clinic visit, all urine samples within the first 240 min will be collected.
Primary outcome [3] 0 0
N-nitrosamines in urine post each intervention after 4 hours up till 24 hours
Timepoint [3] 0 0
After each clinic visit, all urine from 4-hour to 24-hour period will be collected.

Eligibility
Key inclusion criteria
- Six healthy, ambulant, community-dwelling men and women aged between 18 to 55 years
old and with no history of major chronic disease will be recruited from the Perth
general population.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital Research Foundation - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Edith Cowan University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Flinders University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.

A pilot study will be conducted to determine that endogenous N-nitrosamine formation is
observed after ingestion of meat with added nitrate and nitrite and that consumption of
vegetables with the meat containing added nitrate and nitrite will inhibit the production of
N-nitrosamines.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05045807
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Catherine P Bondonno, PhD, RNutr.
Address 0 0
Edith Cowan University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries