protocolSection identificationModule nctId: NCT06273644, orgStudyIdInfo id: HNF1719-24, briefTitle: Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-27, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2037-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Nordlandssykehuset HF, class: OTHER, collaborators name: University of Oslo, collaborators name: Nord University, collaborators name: UiT The Arctic University of Norway, collaborators name: Norwegian University of Science and Technology, collaborators name: The University of Texas Medical Branch, Galveston, descriptionModule briefSummary: 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., conditionsModule conditions: Porphyria, Acute Intermittent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Blinding is attempted by labeling the provided diet plans as A and B. The physician recording outcome variables and the researcher performing statistical analysis are blinded to the given diet., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Carbohydrates, outcomesModule primaryOutcomes measure: Change in Urine Porphobilinogen/creatinine, primaryOutcomes measure: Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements, secondaryOutcomes measure: Number of Hospitalizations,sick leaves, and doctor visits due to AIP, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Plasma Glucose level, secondaryOutcomes measure: Interstitial fluid glucose level, secondaryOutcomes measure: Number of hypoglycemic events, secondaryOutcomes measure: Amino acid profile, secondaryOutcomes measure: Plasma insulin, glucose, c-peptide, secondaryOutcomes measure: HOMA score, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Cytokines in plasma, secondaryOutcomes measure: Intestinal microbiota composition, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Body composition, metabolic age, secondaryOutcomes measure: Mitochondrial oxygen consumption rate, secondaryOutcomes measure: ALAS1mRNA, secondaryOutcomes measure: Urine-ALA/creatinine & urine-porphyrins, secondaryOutcomes measure: Mitochondrial function-related genes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nordland Hospital Trust, status: RECRUITING, city: Bodø, state: Nordland, zip: 8092, country: Norway, contacts name: Elin Storjord, MD PhD, role: CONTACT, phone: +4797072484, email: elin.storjord@nordlandssykehuset.no, contacts name: Hilde Thunhaug, IC nurse, role: CONTACT, phone: +47 95057864, email: hilde.thunhaug@nordlandssykehuset.no, contacts name: Elin Storjord, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Amy Dickey, MD, role: SUB_INVESTIGATOR, contacts name: Bjørn Steen Skålhegg, PhD, Prof., role: SUB_INVESTIGATOR, contacts name: Bård O. Karlsen, PhD, role: SUB_INVESTIGATOR, contacts name: Elin Røst, Master, role: SUB_INVESTIGATOR, contacts name: Erik Knutsen, PhD, role: SUB_INVESTIGATOR, contacts name: Hilde Thunhaug, Bachelor, role: SUB_INVESTIGATOR, contacts name: Jonas Aakre Wik, PhD, role: SUB_INVESTIGATOR, contacts name: Andersen Karl, MD, Prof., role: SUB_INVESTIGATOR, contacts name: Pettersen Kristin, Bachelor, role: SUB_INVESTIGATOR, contacts name: Marlene B. Karlsen, Master, role: SUB_INVESTIGATOR, contacts name: Nina Lorentsen, Master, role: SUB_INVESTIGATOR, contacts name: Ole-Lars Brekke, MD,PhD,Prof, role: SUB_INVESTIGATOR, contacts name: Randolf Hardersen, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Rita Laastad, Bachelor, role: SUB_INVESTIGATOR, contacts name: Steinar Daae Johansen, PhD, Dean, role: SUB_INVESTIGATOR, contacts name: Tor Erik Jørgensen, PhD, role: SUB_INVESTIGATOR, contacts name: Vegar Rangul, PhD, role: SUB_INVESTIGATOR, contacts name: Åse Emblem, PhD, role: SUB_INVESTIGATOR, contacts name: Fredrik Ellefsrud, MD, role: SUB_INVESTIGATOR, contacts name: Tor Claudi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 67.28, lon: 14.40501, hasResults: False