Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of AIP

Locations
Other Locations
Norway
Nordland Hospital Trust
RECRUITING
Bodø
Sweden
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Norrland University Hospital
RECRUITING
Umeå
Contact Information
Primary
Elin Storjord, MD PhD
elin.storjord@nordlandssykehuset.no
97072484
Backup
Hilde Thunhaug, Nurse
hilde.thunhaug@nordlandssykehuset.no
95057864
Time Frame
Start Date: 2024-01-27
Estimated Completion Date: 2037-12-31
Participants
Target number of participants: 50
Treatments
Experimental: 60-65 E% Carbohydrates
Diet plan A with 60-65 E% Carbohydrates in 4 weeks
Active_comparator: 40-45% Carbohydrates
Diet plan B with 40-45 E% Carbohydrates in 4 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Nord University, University of Oslo, Karolinska University Hospital, The University of Texas Medical Branch, Galveston, UiT The Arctic University of Norway, Norwegian University of Science and Technology, Norrlands Universitetssjukhus, Umea, Sweden
Leads: Nordlandssykehuset HF

This content was sourced from clinicaltrials.gov