Towards Personalized Nutrition With SCAPIS2-HOME

The Swedish CardioPulmonary bioImage Study (SCAPIS) is a nationwide, open-access, population-based cohort in Sweden designed to study cardiovascular disease and chronic obstructive pulmonary disease. In January 2024, the reexamination of half of the cohort from SCAPIS1 started (the SCAPIS2). In SCAPIS2-HOME (a sub-study of SCAPIS2), individual responses to standardized isocaloric breakfasts and repeated Mixed Meal Tolerance Tests (MMTTs) will be investigated. For this purpose, participants from the SCAPIS baseline cohort will be invited to take part in a 10-day intervention study, where participants will consume breakfast meals at clinic and the MMTTs at home. The breakfast meals will include ordinary cereal products that consist of either whole grain or refined grain foods served along with other typical breakfast items to be part of either a low-carbohydrate/high-fat or high-carbohydrate/low-fat breakfast. For the MMTTs, we will use standardized meal formulas called PhenFlex, which are high in calories, fat, and glucose and will be consumed repeatedly at home in the evening or the morning. Blood samples will be analyzed using clinical markers such as C-peptide, triglycerides, and markers of inflammation along with metabolomics. Continuous glucose monitoring will be used to obtain 24-hour interstitial glucose concentrations every 15 minutes during the 10-day intervention. Fecal- and blood samples will also be collected along with dietary assessments. The research aims to understand the differential metabolic responses (glycemia, insulinemia, lipid profile, inflammation markers, and key metabolites) individuals may show after consuming whole grains or refined grains as part of breakfasts with high or low carbohydrate content. It is further to characterize to what extent an individual's specific characteristics, including the microbiota, health status, anthropometry, and habitual diet, drive such response differences. Since the study is a sub-set of the SCAPIS cohort, there are unique possibilities to relate the postprandial responses to hard risk factors such as prediabetic status (measured by oral glucose tolerance test), hepatic steatosis (liver fat deposition) and atherosclerotic plaque in the coronary arteries.

NCT Number	NCT06992921
Lead Sponsor	Chalmers University of Technology Collaborators: Göteborg University, Umeå University, Hjärt-Lungfonden, Sweden, Lantmännen
Conditions	Cardiovascular Disease (CVD), Chronic Obstructive Pulmonary Disease (COPD)
Enrollment	1,641 participants
Start Date	2024-01-01
Primary Completion	2025-11-27 (estimated)
Study Completion	2025-12-04 (estimated)
Updated on ClinicalTrials.gov	2026-03-19