The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).
Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).
Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.
Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates.
Diagnosis of AIP
Not having diagnosis of AIP
Undergoing treatment as part of other clinical research on AIP
Pregnancy
Diabetes
Crossover
Carbohydrates
Other interventionHalf of the patients will initially follow Diet Plan A with 60-65 E% carbohydrates for 4 weeks, followed by a 4-week washout period, and then Diet Plan B with 40-45 E% carbohydrates for 4 weeks. The other half will start with Diet Plan B for 4 weeks, followed by a 4-week washout period, and then Diet Plan A for 4 weeks . Diet Plans A and B contain recommended and adequate nutrients according to the Nordic Nutrition Recommendations 2023 (NNR2023) for maintaining a stable weight.
Change in Urine Porphobilinogen/creatinine
AIP biochemical disease activity. First morning Urine Porphobilinogen/creatinine. Change from baseline before diet A to immediately after diet A, and change from baseline before diet B to immediately after diet B
Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements
AIP biochemical disease activity, repeated measurements Percentage change in the median of repeated measurements of Urine Porphobilinogen/creatinine concentrations between Diet A and Diet B The repeated measurements in urine analyzed in urine samples from Day 1 ,4, 8, 11, 15, 18, 22, 25 and 29 of Diet A and of Diet B, and calculated median of Urine Porphobilinogen/creatinine concentration for diet A and median for diet B
Number of Hospitalizations,sick leaves, and doctor visits due to AIP
Using questionnaire counting Number of hospitalizations, sick leaves, and doctor visits due to AIP * In the 4 weeks before Diet A, measured at baseline immediately before Diet A * In the 4 weeks of Diet A, measured immediately after Diet A. * In the 4 weeks before Diet B, measured at baseline immediately before Diet B * in the 4 weeks of Diet B, measured immediately after Diet B
Health status
A standardized questionnaire assessing health (RAND-36) with a 4-week time frame from 0 (worst functioning) to 100 (best functioning), where 2 to 5 points represent a clinically meaningful difference based on data from other chronic diseases.
Plasma Glucose level
Plasma glucose concentration
Interstitial fluid glucose level
Glucose measured in the interstitial fluid (ISF) Measuring is performed continuously by ISF glucose sensor FreeStyle Libre 3 in the 4 weeks of Diet A and in the 4 weeks of Diet B. Outcome is percentage change in the mean of repeated measurements between Diet A and Diet B. Each tissue glucose sensor lasts 14 days, and hence the outcome measure will be assessed each 14 days, and read in the LibreView program. The sensor is placed on the back of the participants upper arm
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Nordlandssykehuset HF
Lead sponsor
University of Oslo
Collaborator
Nord University
Collaborator
UiT The Arctic University of Norway
Collaborator
Norwegian University of Science and Technology
Collaborator
The University of Texas Medical Branch, Galveston
Collaborator
Karolinska University Hospital
Collaborator
University Hospital, Umeå
Collaborator
