Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
IBD, i.e., Mb Crohn or ulcerrative colitis
Moderatively active disease (calprotectin 200-600)
Disqualifiers
Proctitis alone
Inactive disease
Severe flare up requiring in-patient care
Planned change of treatment
Trial design
Design model
Single group
Treatments tested in this trial
Nordiet
Dietary supplementIntervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Microbial composition
Gut 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.
Time frame
Four weeksSecondary outcomes
1
Disease activity
Laboratory data: Calprotectin (mg/kg); lower level is better.
Time frame
Four weeks2
Disease activity
Questionnaires: Harvey-Bradshaw Index (ulcerative colitis). Lower levels are in accordance with lower disease activity.
Time frame
Four weeks3
Disease activity
Questionnaires: CDAI (Crohn's Disease Activity Index). Lower levels are in accordance with lower disease activity.
Time frame
Four weeksOther outcomes
1
Sleep quality
Activity bracelets will be used for measurements of sleep quality: This is based on a value that is a combination of time for sleep onset (minutes, shorter is better), the number of awakenings (fewer is better) and the amount of REM sleep during the night (minutes, more is better). A cut-off level is not appropriate. It is indvidual and must be based both on absolute outcome and relative change.
Time frame
Four weeks.Sponsors and contacts
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Region Skane
Lead sponsor
Malmö University
Collaborator
Lund University
Collaborator
Linkoeping University
Collaborator
Source ClinicalTrials.gov