NCT07016334

Brief 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 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Sep 2022Dec 2027

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 11, 2025

Status Verified

May 1, 2025

Enrollment Period

4.3 years

First QC Date

May 21, 2025

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Sampled at birth (day 1)

Study Arms (3)

Anorexia nervosa

Diagnosed (life-time) with anorexia nervosa

Bulimia nervosa

Diagnosed (life-time) with bulimia nervosa

Controls

Never diagnosed with anorexia or bulimia nervosa

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population born from 1981 with/or with out diagnosis of anorexia or bulimia nervosa

You may qualify if:

  • \- in PKU-register with or withou life-time diagnosis of anorexia or bulimi nervosa

You may not qualify if:

  • not in PKU register

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
44 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 11, 2025

Study Start

September 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 11, 2025

Record last verified: 2025-05

Locations