An interventional study of General healthy diet and Personalized diet in Metabolic Control, sponsored by Chalmers University of Technology. Recruiting at 3 sites in 3 countries. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Chalmers University of Technology · Not applicable, Interventional, and Prevention
The overall objective of this multi-center study is to use metabolic response data from different dietary challenges to develop personalized dietary advice. Effectiveness of this personalized dietary advice compared to a general healthy diet based on national dietary guidelines on markers of cardio-metabolic health will be tested.
A total of 120 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will be conducted at three sites: Chalmers University of Technology (Sweden), University of Wageningen (Netherlands), and University of Oslo (Norway), with 40 participants per site.The study is conducted in two parts. The first part, the characterization phase, is a three-way randomized, controlled cross-over design, featuring one-day meal tests with isocaloric meals containing different carbohydrate, fat and protein quantity as well as quality. Based on the metabolic response to the meal tests a personalized diet will be constructed. In the second part, the main intervention, effectiveness of this personalized dietary advice compared to a general healthy diet will be tested in a six week parallel group intervention study.
Chalmers University of Technology is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
General healthy diet based on national health dietary guidelines.
Other: General healthy diet
Personalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters
Other: Personalized diet
General healthy diet based on national health dietary guidelines.
Personalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters.
Glucose postprandial
Difference between groups in postprandial glucose in response to a mixed meal tolerance test.
Time frame: 6 weeks
Triglycerides postprandial
Difference between groups in postprandial triglycerides in response to a mixed meal tolerance test.
Time frame: 6 weeks
Interleukin-6 postprandial
Difference between groups in postprandial interleukin-6 in response to a mixed meal tolerance test.
Time frame: 6 weeks
Inflammatory markers in blood
Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Appetite
Differences in self-reported appetite measured using a visual analogue scale between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Gut microbiome
Differences in fecal microbiome between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Metabolome
Differences in metabolome (plasma, urine and feces) between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Lipid metabolism
Differences in lipid metabolism between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Glycemic variability
Differences in glycemic variability across the different meals and the OGTT throughout the characterization phase of the study.
Time frame: 4 weeks
Gastrointestinal hormones
Release of gastrointestinal hormones (such as GLP-1, CCK) in response to the test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Fecal proteome
Differences in fecal proteome between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
PBMC Transcriptome
Differences in peripheral blood mononuclear cell gene expression between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
PBMC Epigenome
Differences in peripheral blood mononuclear cell epigenome between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
PBMC Immunometabolism
Differences in peripheral blood mononuclear cell immunometabolism between test meals in the characterization phase of the study.
Time frame: 6-hour meal test
Metabolome
Difference in metabolome (plasma, urine and feces) between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
PBMC Epigenome
Difference in peripheral blood mononuclear cell epigenome between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
PBMC Transcriptome
Difference in peripheral blood mononuclear cell transcriptome between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
PBMC Immunometabolism
Difference in peripheral blood mononuclear cell immunometabolism between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
Fecal proteome
Difference in fecal proteome between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
Gut microbiome
Difference in fecal microbiome between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
Inflammatory markers in blood
Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) to mixed meal tolerance tests between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
Glycemic variability
Differences in glycemic variability between personalized diet and general healthy diet in the intervention phase of the study.
Time frame: 6 weeks
Data-driven prediction of response to intervention
Data-driven prediction of primary and other outcomes to personalized diet vs. general healthy diet using metabolome, gut microbiome, epigenome, transcriptome, proteome, immunometabolism, health measures, lifestyle and metabolic markers as determinants.
Time frame: 6 weeks
Dietary biomarkers
Exploratory analysis of blood, urine and feces to find potential biomarkers reflecting dietary intake in the characterization and intervention phase of the study.
Time frame: 6-hour meal test and 6 week intervention
Responsivness to diet
Exploration of underlying mechanisms behind response/non-response to personalized and general healthy diet using data from both the characterization phase (meal test) and the primary 6-week intervention.
Time frame: 6-hour test meal and 6 week intervention
Gastric emptying
Gastric emptying will be assessed by breath test at one of the test meals in a sub-group of participants (Swedish and Norwegian site).
Time frame: 6-hour test meal
Gastric passage time
Gastric passage time will be assessed using the blue dye method.
Time frame: 6-hour meal test and 6 week intervention
Plan to share: Undecided
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Chalmers University of Technology