Dietary Nitrate and Nitrite Intake and Phosphate Biomarkers and Risk of Chronic Diseases (NCT07746310) | Clinical Trial Compass
CompletedNot Applicable
Dietary Nitrate and Nitrite Intake and Phosphate Biomarkers and Risk of Chronic Diseases
Sweden86,000 participantsStarted 1987-01-01
Plain-language summary
Nitrate, nitrite, and phosphate (NO3, NO2, P) are at all age stages ubiquitous in our everyday foods, including naturally occurring and as food additives, and in our drinking water. These compounds are essential in maintaining human well-being and health, but they have also been linked to detrimental health effects including contribution to cancer initiation and artery calcification, making it difficult to evaluate their overall health impact.
Therefore, the overarching aim of this project is to shed light on the potential dual effect of these compounds on a variety of chronic diseases (cardiovascular and respiratory diseases, gastrointestinal cancers) at different life stages and to further elucidate on the molecular mechanisms suggested to underly the pathogenesis of these disease outcomes.
This will be achieved by using prospective, longitudinal population-based cohorts linked to comprehensive databases of NO3 and NO2 and using a biomarker of P while also integrating omics data on inflammatory and cardiometabolic biomarkers as well as the microbiome and urine bacterial metabolites. The project will be led by the PI and conducted by a team of PhD students and postdoc in close collaboration with relevant experts. It will be initiated early on and continued throughout a 4-year study period.
With this research, the investigators attempt to provide the strongest scientific evidence with etiologically more relevant exposure-disease associations and to shape future health risk assessments.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
SMC and COSM
* Born between 1914 and 1948 (SMC) or through 1952 (COSM)
* Residing in Västmanland and Uppsala counties (SMC)
* Residing in Västmanland and Örebro counties (COSM)
BAMSE cohort
* All children born in certain areas of northern and central Stockholm between Feb 1994 and Nov 1996.
Exclusion Criteria:
SMC and COSM
* Incorrect or missing national registration number
* Prevalent disease at baseline (depending on research question)
* Implausible energy intake
BAMSE cohort
* The family planned to move within 1 year of the study start;
* Insufficient knowledge of the Swedish language;
* The family had a seriously ill child or
* an older sister or brother was already included in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at dietary nitrate and nitrite intake alongside phosphate biomarkers in relation to conditions like gastrointestinal cancer, cardiovascular disease, and asthma — does anything in my current diet or my phosphate levels make these findings relevant to my own health risks?
2The trial measured gut microbiota changes using genetic sequencing — given that my gut health could play a role in my condition, is there any reason you'd recommend I look into microbiome testing based on what studies like this are finding?
3Since this study tracked inflammatory biomarkers using the Olink Inflammation panel, are any of those specific inflammatory markers something you'd consider monitoring in my case, and would the results of a completed study like this influence how you interpret my lab work?
4The trial enrolled healthy participants alongside people with conditions like COPD and cardiovascular disease — based on where I am with my own diagnosis, do you think the findings from a mixed population like this would apply meaningfully to my situation?
5Because this was an observational or epidemiological study rather than a treatment trial, how much weight should I give its findings when thinking about whether changes to my nitrate and nitrite intake — like eating more or fewer processed foods and vegetables — might actually reduce my risk?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastrointestinal cancers incidence
Timeframe: Through study completion, an average of 25 years
2
Cardiovascular diseases incidence
Timeframe: Through study completion, an average of 25 years
3
Chronic obstructive pulmonary disease incidence
Timeframe: Through study completion, an average of 25 years
4
Differential abundance of gut microbiota sequenced using DNBseq
Timeframe: At baseline (time of sample collection)
5
Asthma incidence
Timeframe: From birth through young adulthood (up to 24 years of age)
6
Lung function (FEV1 and FVC)
Timeframe: Assessed every 8 years
7
Concentrations of inflammatory biomarkers assessed by Olink Inflammation panel