HealthyNCT07746310
Dietary Nitrate and Nitrite Intake and Phosphate Biomarkers and Risk of Chronic Diseases
An observational study of Healthy and Gastrointestinal Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gastrointestinal Cancer, Cardiovascular Diseases
- How many people
- 86,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 1987to 31 Dec 2024
- How long will I take part?
- 26 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We plan to use data from two population-based and longitudinal cohorts of middle-aged to elderly women and men, parts of the Swedish Infrastructure for Medical Population-based Life-course and Environmental Research (SIMPLER). The SMC was established in 1987-90 to which all women born in 1914-48, living in the counties of Uppsala and Västmanland in Sweden, were invited to participate in. In 1997, the COSM was established inviting all men born in 1918-1952 and living in Västmanland and Örebro counties in Sweden. Questionnaire information has been repeatedly collected in 1987-90, 1997, 2008/9, and in 2019. Clinical sub-cohorts (SMC-C and COSM-C) were established between 2003 and 2010. We will also use data from the population-based prospective birth cohort BAMSE. The cohort was established in 1994-96, when 4,089 newborn children in two areas in Stockholm were invited to participate in the study.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitrate, Nitrite and Phosphate and the Public Health - The Good and the Bad of Natural Components Ubiquitously Found in Our in Food and Drinking Water
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.
Read more
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.
- Conditions
- Healthy, Gastrointestinal Cancer, Cardiovascular Diseases, Chronic Obstructive Airway Disease, Asthma (Diagnosis)
- Medical subject headings
- Gastrointestinal Neoplasms, Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Swedish Mammography Cohort (SMC) | Not described | |
| Cohort of Swedish Men (COSM) | Not described | |
| Barn, Allergi, Miljö, Stockholm, Epidemiologi (BAMSE) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal cancers incidence
In SIMPLER cohorts
Measured: Through study completion, an average of 25 years
Cardiovascular diseases incidence
In SIMPLER cohorts
Measured: Through study completion, an average of 25 years
Chronic obstructive pulmonary disease incidence
In SIMPLER cohorts
Measured: Through study completion, an average of 25 years
Differential abundance of gut microbiota sequenced using DNBseq
In SIMPLER cohorts and sequenced using DNBseq technology (BGI) and computationally analysed using both MetaPhlAn4 and CHAMP (CM HumAn Microbiome Profiler 2.0, Clinical Microbiomics)
Measured: At baseline (time of sample collection)
Asthma incidence
In BAMSE cohort
Measured: From birth through young adulthood (up to 24 years of age)
Lung function (FEV1 and FVC)
In BAMSE cohort and measured using spirometry according to the ATS/ERS spirometry criteria (at age 8 years using a 2200 Pulmonary Function Laboratory (SensorMedics), at 16 years of age using a Jaeger MasterScreen-IOS system (CareFusion Technologies), and at 24 years using a Vyaire Vyntus system (Vyaire Medical))
Measured: Assessed every 8 years
Concentrations of inflammatory biomarkers assessed by Olink Inflammation panel
In BAMSE cohort, using the Olink Target 96 Inflammation panel, which measures relative protein levels reported as Normalized Protein eXpression (NPX) values on a log2 scale. All proteins included in the panel (approximately 92) will be analyzed individually in an exploratory manner.
Measured: At 24 years of age
Secondary outcomes (1)
Urinary bacterial metabolite profiles assessed by non-targeted LC-HRMS
In BAMSE cohort, urinary metabolites will be assessed using non-targeted screening by liquid chromatography high-resolution mass spectrometry (LC-HRMS) and reported as relative peak intensities (arbitrary units) for detected metabolic features, including bacterial-derived metabolites, in an exploratory manner.
Measured: At 24 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jan 1987
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86,000 participants (actual)
- Target duration
- 26 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agneta Åkesson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746310
- Sponsor's protocol ID
- 2025-02373
- Other IDs
- 2025
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrate, Nitrite and Phosphate and the Public Health - The Good and the Bad of Natural Components Ubiquitously Found in Our in Food and Drinking Water
- ClinicalTrials.gov ID
- NCT07746310
- Acronym / sponsor ID
- 2025-02373
- Conditions
- Healthy, Gastrointestinal Cancer, Cardiovascular Diseases, Chronic Obstructive Airway Disease, Asthma (Diagnosis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 1987 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Swedish Mammography Cohort (SMC) | – | – |
| Cohort of Swedish Men (COSM) | – | – |
| Barn, Allergi, Miljö, Stockholm, Epidemiologi (BAMSE) | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We plan to use data from two population-based and longitudinal cohorts of middle-aged to elderly women and men, parts of the Swedish Infrastructure for Medical Population-based Life-course and Environmental Research (SIMPLER). The SMC was established in 1987-90 to which all women born in 1914-48, living in the counties of Uppsala and Västmanland in Sweden, were invited to participate in. In 1997, the COSM was established inviting all men born in 1918-1952 and living in Västmanland and Örebro counties in Sweden. Questionnaire information has been repeatedly collected in 1987-90, 1997, 2008/9, and in 2019. Clinical sub-cohorts (SMC-C and COSM-C) were established between 2003 and 2010. We will also use data from the population-based prospective birth cohort BAMSE. The cohort was established in 1994-96, when 4,089 newborn children in two areas in Stockholm were invited to participate in the study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- SMC and COSM
- Incorrect or missing national registration number
- Prevalent disease at baseline (depending on research question)
- Implausible energy intake
- BAMSE cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastrointestinal cancers incidence
Time frame: Through study completion, an average of 25 years
In SIMPLER cohorts
Cardiovascular diseases incidence
Time frame: Through study completion, an average of 25 years
In SIMPLER cohorts
Chronic obstructive pulmonary disease incidence
Time frame: Through study completion, an average of 25 years
In SIMPLER cohorts
Differential abundance of gut microbiota sequenced using DNBseq
Time frame: At baseline (time of sample collection)
In SIMPLER cohorts and sequenced using DNBseq technology (BGI) and computationally analysed using both MetaPhlAn4 and CHAMP (CM HumAn Microbiome Profiler 2.0, Clinical Microbiomics)
Asthma incidence
Time frame: From birth through young adulthood (up to 24 years of age)
In BAMSE cohort
Lung function (FEV1 and FVC)
Time frame: Assessed every 8 years
In BAMSE cohort and measured using spirometry according to the ATS/ERS spirometry criteria (at age 8 years using a 2200 Pulmonary Function Laboratory (SensorMedics), at 16 years of age using a Jaeger MasterScreen-IOS system (CareFusion Technologies), and at 24 years using a Vyaire Vyntus system (Vyaire Medical))
Concentrations of inflammatory biomarkers assessed by Olink Inflammation panel
Time frame: At 24 years of age
In BAMSE cohort, using the Olink Target 96 Inflammation panel, which measures relative protein levels reported as Normalized Protein eXpression (NPX) values on a log2 scale. All proteins included in the panel (approximately 92) will be analyzed individually in an exploratory manner.
1 secondary outcome
Urinary bacterial metabolite profiles assessed by non-targeted LC-HRMS
Time frame: At 24 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Gastrointestinal Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal cancers incidence (time frame: Through study completion, an average of 25 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.