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Trial details imported from ClinicalTrials.gov

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

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

Congenital Adrenal Hyperplasia

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Experimental: ARO-C3 (Adult Patients with C3G or IgAN) - 3 doses of ARO-C3 by sc injection

Comparator / control treatment

Control group

Outcomes

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

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

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Primary sponsor type

Other

Name

Edith Cowan University

Address

Country

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/study/NCT05045807

Trial related presentations / publications

Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Catherine P Bondonno, PhD, RNutr.

Address

Edith Cowan University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05045807

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05045807