Nitrate INFORMER Nitrosamine Study

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.

Conditions

• Health Risk Behaviors

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Meat with added nitrate plus vegetables

The same intervention as of intervention "meat with added nitrate" consumed together with mixed vegetables.

Sponsors & Collaborators

• The University of Western Australia

  collaborator OTHER

• Flinders University

  collaborator OTHER

• Edith Cowan University

  lead OTHER

Principal Investigators

• Catherine P Bondonno, PhD, RNutr. · Edith Cowan University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-11

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Australia

Study Locations