Last reviewed · How we verify
NCT05075720
Nitrate INFORMER Meat Study
NA trial testing Meat with added nitrate in Health Risk Behaviors in 25 participants. Completed in 13 December 2022.
13 December 2022
Quick facts
| Lead sponsor | Edith Cowan University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 25 |
| Start date | 27 September 2022 |
| Primary completion | 13 December 2022 |
| Estimated completion | 13 December 2022 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Meat with added nitrate
- Meat without added nitrate
- Control
Conditions studied
- Health Risk Behaviors — all drugs for Health Risk Behaviors →
Sponsor
Edith Cowan University
Who can join
Adults 18 to 70, 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 meat with and without added nitrate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05075720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Meat with added nitrate
Trials testing the same drug.
- NCT05045807 — Nitrate INFORMER Nitrosamine Study · NA · completed
Other recruiting trials for Health Risk Behaviors
Currently open trials in the same condition.
- NCT07032480 — Association Between Sleep Disorders, Neck Pain, and Depression · recruiting
- NCT06181929 — A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females · NA · recruiting
- NCT05665179 — Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis · NA · recruiting
- NCT03292094 — The African-PREDICT Study · active not recruiting
Other Edith Cowan University trials
Trials by the same sponsor.
- NCT05886023 — Nitrate INFORMER Vegetable Study · NA · completed
- NCT05710341 — Nitrate INFORMER Water Study · NA · completed
- NCT05045807 — Nitrate INFORMER Nitrosamine Study · NA · completed
- NCT04018040 — Vegetarian Diet in IBD · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05075720 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Edith Cowan University
- Last refreshed: 1 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05075720.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing