Health Risk Behaviors Clinical Trial
Official title:
Randomised Controlled Trial to Investigate N-nitrosamine Formation After Vegetable Intake
Verified date | April 2024 |
Source | Edith Cowan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 75 years old - healthy, ambulant, community-dwelling - with no history of major chronic disease 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Perth Hospital Research Foundation | Perth | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Edith Cowan University | Flinders University, The University of Western Australia |
Australia,
Blekkenhorst LC, Bondonno NP, Liu AH, Ward NC, Prince RL, Lewis JR, Devine A, Croft KD, Hodgson JM, Bondonno CP. Nitrate, the oral microbiome, and cardiovascular health: a systematic literature review of human and animal studies. Am J Clin Nutr. 2018 Apr — View Citation
Blekkenhorst LC, Prince RL, Ward NC, Croft KD, Lewis JR, Devine A, Shinde S, Woodman RJ, Hodgson JM, Bondonno CP. Development of a reference database for assessing dietary nitrate in vegetables. Mol Nutr Food Res. 2017 Aug;61(8). doi: 10.1002/mnfr.2016009 — View Citation
Gangolli SD, van den Brandt PA, Feron VJ, Janzowsky C, Koeman JH, Speijers GJ, Spiegelhalder B, Walker R, Wisnok JS. Nitrate, nitrite and N-nitroso compounds. Eur J Pharmacol. 1994 Nov 1;292(1):1-38. doi: 10.1016/0926-6917(94)90022-1. — View Citation
Lundberg JO, Weitzberg E. NO-synthase independent NO generation in mammals. Biochem Biophys Res Commun. 2010 May 21;396(1):39-45. doi: 10.1016/j.bbrc.2010.02.136. — View Citation
Spiegelhalder B, Eisenbrand G, Preussmann R. Influence of dietary nitrate on nitrite content of human saliva: possible relevance to in vivo formation of N-nitroso compounds. Food Cosmet Toxicol. 1976 Dec;14(6):545-8. doi: 10.1016/s0015-6264(76)80005-3. No — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | N-nitrosamines in urine post intervention (up to 24 hours) | Participants will be provided with sterilized containers and instructions to collect all urine until 24 hours post intervention> Urine aliquots will be frozen at -80°C until analysis. N-nitrosamines will be measured by gas chromatography mass spectrometry (GCMS). | At each clinic visit, all urine from the start of intervention up till 24 hours will be collected | |
Primary | N-nitrosamines in stool samples post intervention (up to 24 hours) | Participants will be provided with instructions and a stool sample collection pack (collection bags, cable ties, large zip lock bags, freezer ice blocks and a designated cooler bag for transport). Collected stool samples will be weighed and frozen at -80°C until analysis. N-nitrosamines will be measured by gas chromatography mass spectrometry (GCMS). | At each clinic visit, all stool samples from the start of intervention up till 24 hours will be collected |
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