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OpenTrials
Completed

NCT Number: NCT07746310

Dietary Nitrate and Nitrite Intake and Phosphate Biomarkers and Risk of Chronic Diseases

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.

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Key information

Conditions

Healthy Asthma Asthma (Diagnosis) Bronchial Diseases Cardiovascular Diseases Chronic Disease Chronic Obstructive Airway Disease Digestive System Diseases Digestive System Neoplasms Disease Disease Attributes Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Gastrointestinal cancers incidence

    Time frame: Through study completion, an average of 25 years

    In SIMPLER cohorts

  2. Cardiovascular diseases incidence

    Time frame: Through study completion, an average of 25 years

    In SIMPLER cohorts

  3. Chronic obstructive pulmonary disease incidence

    Time frame: Through study completion, an average of 25 years

    In SIMPLER cohorts

  4. 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)

  5. Asthma incidence

    Time frame: From birth through young adulthood (up to 24 years of age)

    In BAMSE cohort

  6. 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))

  7. 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.

Secondary outcomes

  1. Urinary bacterial metabolite profiles assessed by non-targeted LC-HRMS

    Time frame: At 24 years of age

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Important dates

Study start
1987
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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