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Could common food additives be friend or foe? a massive study investigates

NCT ID NCT07746310

Knowledge-focused Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This large observational study is investigating whether nitrate, nitrite, and phosphate—compounds found naturally in food and water and used as additives—are linked to chronic diseases like gastrointestinal cancers, heart disease, and respiratory conditions. Researchers will follow data from over 86,000 people across different age groups, using health records and biological samples to explore potential dual effects. The goal is to better understand how these everyday substances might influence health at different life stages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
This research could clarify whether these common food and water compounds are harmful or helpful, potentially shaping future dietary guidelines and health risk assessments.
What could go wrong
Because this is an observational study, it can show associations but not prove cause and effect. Many factors influence disease risk, so findings may not lead to definitive conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

86,000 people

The number who actually took part.

Started

Jan 1987

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma cardiovascular disorder chronic obstructive pulmonary disease digestive system cancer digestive system neoplasm disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma (diagnosis) Cardiovascular diseases Chronic obstructive airway disease Gastrointestinal cancer Healthy

Contacts and locations

Locations

  • Karolinska Institutet

    Stockholm, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.