NCT Number: NCT07389161
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
Malmö, 21428, Sweden
Location status: Recruiting
Klas Sjöberg, Adj professor
CONTACT
40336161 ext. +46
Klas Sjöberg, Adj professor
PRINCIPAL_INVESTIGATOR
Vedrana Vejzovic, Associate professor
CONTACT
40-665 74 46 ext. +46
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.
Time frame: Four weeks
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 weeks
Laboratory data:
Calprotectin (mg/kg); lower level is better.
Time frame: Four weeks
Questionnaires:
Harvey-Bradshaw Index (ulcerative colitis). Lower levels are in accordance with lower disease activity.
Time frame: Four weeks
Questionnaires:
CDAI (Crohn's Disease Activity Index). Lower levels are in accordance with lower disease activity.
Time frame: Four weeks.
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.
Contact information is provided by the study sponsor or research team.
Klas Sjöberg, Adj professor
CONTACT
+46 40 33 61 61 ext. +46
Vedrana Vejzovic, Associate professor
CONTACT
+46 40 665 74 46 ext. +46
Region Skane
Other
Acronym: UNITA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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