Eating DisordersNCT07016334
We Analyse Metabolites in Dried Blood Spots From Newborns That Later in Life Developed an Eating Disorder.
An observational study of Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Anorexia nervosa (AN) and bulimia nervosa (BN) are serious eating disorders (EDs) with significant morbidity and mortality. Genetic studies have shown associations between EDs and metabolic traits, and longitudinal studies indicate distinct weight trajectories in children who later develop AN or BN, suggesting early… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eating Disorders
- How many people
- 3,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2022to Dec 2027
- How long will I take part?
- 44 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population born from 1981 with/or with out diagnosis of anorexia or bulimia nervosa
Who may be able to join
- in PKU-register with or withou life-time diagnosis of anorexia or bulimi nervosa
Who cannot join
- not in PKU register
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Metabolic, Immune, and Neurotrophic Markers in the Etiology of Eating Disorders Using Neonatal Bloodspots
Anorexia nervosa (AN) and bulimia nervosa (BN) are serious eating disorders (EDs) with significant morbidity and mortality. Genetic studies have shown associations between EDs and metabolic traits, and longitudinal studies indicate distinct weight trajectories in children who later develop AN or BN, suggesting early involvement of metabolic factors. Biological studies also reveal differences in immune and neurotrophic markers in individuals with EDs compared to controls. Intriguingly, metabolites measured in neonatal blood could serve as very early markers of ED risk, unconfounded by state or scar factors related to prolonged starvation.
Here the investigators propose to comprehensively analyze neonatal biomarkers (metabolic, immune, and neurotrophic), epidemiological factors, and genetics to understand ED risk and develop risk prediction models
- Conditions
- Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders
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 |
|---|---|---|
| Anorexia nervosa | Diagnosed (life-time) with anorexia nervosa | |
| Bulimia nervosa | Diagnosed (life-time) with bulimia nervosa | |
| Controls | Never diagnosed with anorexia or bulimia nervosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic factors measured by mass-spectrometry
Metabolomic factors such as amino acids, sugars, lipids, and organic acids extracted from dried blood spots sampled at birth are measured by mass spectrometry
Measured: Sampled at birth (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Sep 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
- Target duration
- 44 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida AK Nilsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016334
- Sponsor's protocol ID
- Analysis of blood spots in ED
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Metabolic, Immune, and Neurotrophic Markers in the Etiology of Eating Disorders Using Neonatal Bloodspots
- ClinicalTrials.gov ID
- NCT07016334
- Acronym / sponsor ID
- Analysis of blood spots in ED
- Conditions
- Eating Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
Anorexia nervosa (AN) and bulimia nervosa (BN) are serious eating disorders (EDs) with significant morbidity and mortality. Genetic studies have shown associations between EDs and metabolic traits, and longitudinal studies indicate distinct weight trajectories in children who later develop AN or BN, suggesting early involvement of metabolic factors. Biological studies also reveal differences in immune and neurotrophic markers in individuals with EDs compared to controls. Intriguingly, metabolites measured in neonatal blood could serve as very early markers of ED risk, unconfounded by state or scar factors related to prolonged starvation.
Here the investigators propose to comprehensively analyze neonatal biomarkers (metabolic, immune, and neurotrophic), epidemiological factors, and genetics to understand ED risk and develop risk prediction models
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 44 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | – | –Diagnosed (life-time) with anorexia nervosa |
| Bulimia nervosa | – | –Diagnosed (life-time) with bulimia nervosa |
| Controls | – | –Never diagnosed with anorexia or bulimia nervosa |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population born from 1981 with/or with out diagnosis of anorexia or bulimia nervosa
Key inclusion criteria (1 listed)
- in PKU-register with or withou life-time diagnosis of anorexia or bulimi nervosa
Key exclusion criteria (1 listed)
- not in PKU register
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
Metabolomic factors measured by mass-spectrometry
Time frame: Sampled at birth (day 1)
Metabolomic factors such as amino acids, sugars, lipids, and organic acids extracted from dried blood spots sampled at birth are measured by mass spectrometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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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 Eating Disorders, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Metabolomic factors measured by mass-spectrometry (time frame: Sampled at birth (day 1)). 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 11 Jun 2025.