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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05075720




Registration number
NCT05075720
Ethics application status
Date submitted
30/08/2021
Date registered
13/10/2021

Titles & IDs
Public title
Nitrate INFORMER Meat Study
Scientific title
Randomised Controlled Trial to Investigate N-nitrosamine Formation After Meat Intake - Meat Study of the Nitrate INFORMER Studies; Nitrate INFORMER Studies: Is Nitrosamine FORMation dEpenent on souRce
Secondary ID [1] 0 0
2021-02629-BONDONNO
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
Treatment: Other - Meat with added nitrate
Treatment: Other - Meat without added nitrate
Treatment: Other - Control

Experimental: Dietary Supplement: Meat with added nitrate - The intervention comprises 50 g salami and 35 g ham on white bread sandwich at breakfast and lunch.

This intervention will allow us to determine both endogenous formation of N-nitrosamines as well as N-nitrosamines present in the commercially prepared meat.

Experimental: Dietary Supplement: Meat without added nitrate - The intervention comprises 65 g Pork mince on white bread sandwich at breakfast and lunch. Nitrate is not an allowed additive in pork mince.

This intervention will allow us to determine if there is endogenous formation of N-nitrosamines as well as N-nitrosamines present in the prepared meat due to the natural content of nitrate in meat.

Sham comparator: Dietary Supplement: Control - The control comprises low nitrate vegetable protein burger on white bread. Protein content matched to interventions 1 and 2.


Treatment: Other: Meat with added nitrate
The intervention comprises 50 g salami and 35 g ham on white bread sandwich at breakfast and lunch.

This intervention will allow us to determine both endogenous formation of N-nitrosamines as well as N-nitrosamines present in the commercially prepared meat.

Treatment: Other: Meat without added nitrate
The intervention comprises 65 g Pork mince on white bread sandwich at breakfast and lunch. Nitrate is not an allowed additive in pork mince.

This intervention will allow us to determine if there is endogenous formation of N-nitrosamines as well as N-nitrosamines present in the prepared meat due to the natural content of nitrate in meat.

Treatment: Other: Control
The control comprises low nitrate vegetable protein burger on white bread. Protein content matched to interventions 1 and 2.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
N-nitrosamines in urine post intervention (up to 24 hours)
Timepoint [1] 0 0
At each clinic visit, all urine from the start of intervention up till 24 hours will be collected.
Primary outcome [2] 0 0
N-nitrosamines in stool samples post intervention (up to 24 hours)
Timepoint [2] 0 0
At each clinic visit, all stool samples from the start of intervention up till 24 hours will be collected.

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
Minimum age
18 Years
Maximum age
70 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
NA
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
27/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2022
Sample size
Target
Accrual to date
Final
25
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Lundberg JO, Weitzberg E. NO-synthase independent ... [More Details]
Journal Blekkenhorst LC, Bondonno NP, Liu AH, Ward NC, Pri... [More Details]
Journal Bondonno CP, Blekkenhorst LC, Liu AH, Bondonno NP,... [More Details]
Journal Spiegelhalder B, Eisenbrand G, Preussmann R. Influ... [More Details]
Journal Tannenbaum SR, Weisman M, Fett D. The effect of ni... [More Details]
Journal Gangolli SD, van den Brandt PA, Feron VJ, Janzowsk... [More Details]
Journal Mirvish SS. Role of N-nitroso compounds (NOC) and ... [More Details]
Journal IARC Working Group on the Evaluation of Carcinogen... [More Details]
Journal Hord NG, Tang Y, Bryan NS. Food sources of nitrate... [More Details]
Journal Blekkenhorst LC, Prince RL, Ward NC, Croft KD, Lew... [More Details]
Journal Bartsch H, Ohshima H, Pignatelli B. Inhibitors of ... [More Details]
Journal Levallois P, Ayotte P, Van Maanen JM, Desrosiers T... [More Details]
Journal Bartholomew B, Hill MJ. The pharmacology of dietar... [More Details]
Journal Bondonno CP, Croft KD, Puddey IB, Considine MJ, Ya... [More Details]
Journal Bondonno CP, Downey LA, Croft KD, Scholey A, Stoug... [More Details]
Journal Callahan BJ, McMurdie PJ, Rosen MJ, Han AW, Johnso... [More Details]
Journal Cole JR, Wang Q, Fish JA, Chai B, McGarrell DM, Su... [More Details]
Journal Parks DH, Chuvochina M, Waite DW, Rinke C, Skarshe... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT05075720