NCT05886023

Nitrate INFORMER Vegetable Study

Completed NA Last updated 16 April 2024

What this trial tests

NA trial testing High nitrate vegetables in Health Risk Behaviors in 27 participants. Completed in 31 October 2023.

Timeline

26 June 2023

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	Edith Cowan University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	27
Start date	26 June 2023
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	1 location across Australia

Drugs / interventions tested

• High nitrate vegetables
• Low nitrate vegetables

Conditions studied

• Health Risk Behaviors — all drugs for Health Risk Behaviors →

Sponsor

Edith Cowan University

Who can join

Adults 18 to 75, any sex, with Health Risk Behaviors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 vegetables with high nitrate content and vegetables with a low nitrate content.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.