Towards Personalized Nutrition With SCAPIS2-HOME

NCT06992921 | Completed

• 1 other identifier: SCAPIS2-HOME
• Study Type: interventional
• Target: 1,641
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiovascular Disease (CVD); Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Personalized nutrition; Precision nutrition; Mixed meal tolerance test; Continuous glucose monitoring; Home sampling

Outcome Measures

Primary Outcomes (4)

• Continuous glucose monitoring (breakfast)

  Differences in 24-hour CGM-measures and in the dynamic features of the postprandial glucose response as evaluated by CGM-home sampling between the different breakfasts

  During breakfast day 1

• Lipemic responses (breakfast)

  Differences in lipemic responses (triglycerides) as evaluated by home sampling between the different breakfasts

  During breakfast day 1 (240 minutes)

• C-peptide (breakfast)

  Differences in C-peptide responses as evaluated by home sampling between the different breakfasts

  During breakfast day 1 (240 minutes)

• Glucose (breakfast)

  Differences in glucose responses as evaluated by home sampling between the different breakfasts

  During breakfast day 1 (240 minutes)

Secondary Outcomes (20)

• Inflammation markers (breakfast)

  During breakfast day 1 (240 minutes)

• Inflammation marker (breakfast)

  During breakfast day 1 (240 minutes)

• Continuous glucose monitoring (MMTT)

  During intervention (day 2-8)

• Lipemic responses (MMTT)

  During intervention (day 2-8)

• C-peptide (MMTT)

  During intervention (day 2-8)

Study Arms (1)

Dietary intervention

EXPERIMENTAL

10-day dietary intervention using standardized test meals

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Iterventional dietary study using standardised meals with different fat content and carbohydrate quantity and quality or mixed meal tolerance test to predict for an individuals metabolic response.

Dietary intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants from the Swedish CArdioPulomonary bioImage Study (SCAPIS)

You may not qualify if:

• Food allergies or intolerances preventing consumption of any products included in the study
• Bariatric surgery, gastric bypass, or sleeve.

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Göteborg University: collaborator
• Umeå University: collaborator
• Hjärt-Lungfonden, Sweden: collaborator
• Lantmännen: collaborator

Study Sites (2)

Region Västerbotten (Kliniskt Forskningscentrum)

Umeå, Västerbotten County, 901 85, Sweden

Location

Sahlgrenska University Hospital (Östra Hospital)

Gothenburg, Västra Götaland County, 416 50, Sweden

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 28, 2025
• Study Start: January 1, 2024
• Primary Completion: November 27, 2025
• Study Completion: December 4, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

SE (2)