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Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults

Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07389161
Acronym
UNITA
Enrollment
160
Registered
2026-02-05
Start date
2026-04-28
Completion date
2029-12-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mb Crohn, Ulcerative Colitis (UC)

Keywords

Diet, Inflammatory bowel disease, Mb Crohn, Ulcerative colitis

Brief summary

The aims of the study are 1. to determine the effect on dysbiosis, permeability and inflammatory activity after administration of a Mediterranean like diet (a Nordic equivalent, "Nordiet"), 2. to investigate life style related factors, such as exercise, psychosexual health and quality of life and their relation to the disease activity.

Detailed description

The project aims, firstly, to map the quality of life and psychosexual health of young IBD patients (18-35 years), secondly, to investigate what treatment effect a changed diet can bring, and thirdly, to investigate whether physical activity and body composition can be related to disease activity. The investigators want to use a natural food based on Mediterranean diet without artificial additives to evaluate the effect on the degree of disease activity through analysis of customary clinical parameters such as symptom picture and lab work including calprotectin (in stool samples) but mainly analysis of the gut microbiota and bacterial DNA in the blood as a marker for intestinal health. Physical activity can be a possible treatment. By combining activity bracelets with analysis of autonomic balance (heart rate variability) and sleep quality, examinations of symptom burden and inflammatory activity, new valuable knowledge can be obtained. Associations have been demonstrated between active IBD, depression, stress, fatigue, quality of life and sexual function in both women and men. It is therefore important to investigate psychosexual health and quality of life among young people with IBD and to also evaluate the effects of intervention through questionnaires and qualitative interviews.

Interventions

DIETARY_SUPPLEMENTNordiet

Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.

Sponsors

Region Skane
Lead SponsorOTHER
Malmö University
CollaboratorOTHER
Lund University
CollaboratorOTHER
Linkoeping University
CollaboratorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Sequential Assignment Prospective non-randomized intevention study where everyone serves as their own control

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* IBD, i.e., Mb Crohn or ulcerrative colitis * Moderatively active disease (calprotectin 200-600)

Exclusion criteria

* Proctitis alone * Inactive disease * Severe flare up requiring in-patient care * Planned change of treatment * Antibiotic treatment during the last month * Pregnancy * Inability to understand Swedish * Multimorbidity

Design outcomes

Primary

MeasureTime frameDescription
Microbial compositionFour weeksGut microbiota will be analyzed at start and after four weeks. The health promoting efect of the diet will be estimated with analysis of the total bacterial genome down to species level. The bacterial composition will then be analyzed with regard to presence of beneficial or harmful bacteria. Based on the complexity of the micorbiota it is not possible to state any specific value that should be achieved.

Secondary

MeasureTime frameDescription
Disease activityFour weeksLaboratory data: Calprotectin (mg/kg); lower level is better.

Countries

Sweden

Contacts

CONTACTKlas Sjöberg, Adj professor
klas.sjoberg@med.lu.se+46 40 33 61 61
CONTACTVedrana Vejzovic, Associate professor
vedrana.vejzovic@mau.se+46 40 665 74 46
STUDY_DIRECTORVedrana Vejzovic, Associate professor

Malmö University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026