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

What this Trial Is About

This research investigates the use of a carbohydrate-rich diet as a treatment for acute intermittent porphyria (AIP), a genetic condition causing buildup of porphobilinogen leading to severe symptoms like abdominal pain, paralysis, fatigue, inflammation, and increased risk of kidney and liver problems. The study aims to understand how different carbohydrate levels impact tissue and serum glucose, insulin, inflammatory markers, amino acids, gut bacteria, mitochondrial activity, and genetic markers in AIP patients. Researchers will explore how these factors relate to AIP symptoms and overall health. Participants will follow two diet plans in a randomized crossover design: one with 60-65% of energy from carbohydrates and another with 40-45% carbohydrates, each lasting four weeks with a four-week washout period between. Half of the participants start with the higher carbohydrate diet and then switch to the lower, while the other half do the reverse. Nutritional plans meet recommended guidelines to maintain stable weight. The study is conducted by multiple institutions, including Nordland Hospital and the University of Oslo, with expert teams developing diets and analyzing results. During the study, participants will have various assessments including urine tests for porphobilinogen, blood and tissue glucose levels, insulin, cytokines, amino acids, gut microbiota, physical activity, body composition, blood pressure, and mitochondrial function. These measures are taken before and after each diet period, with continuous glucose monitoring and physical activity tracking using devices. Researchers will also analyze genetic markers linked to energy metabolism. The total participation includes two four-week diet periods separated by a washout, with detailed monitoring throughout.

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