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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Wageningen University | OTHER |
| Polish Academy of Sciences | OTHER |
| Maastricht University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General healthy diet | Active Comparator | General healthy diet based on national health dietary guidelines. |
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| Personalized diet | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General healthy diet | Other | General healthy diet based on national health dietary guidelines. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose postprandial | Difference between groups in postprandial glucose in response to a mixed meal tolerance test. | 6 weeks |
| Triglycerides postprandial | Difference between groups in postprandial triglycerides in response to a mixed meal tolerance test. | 6 weeks |
| Interleukin-6 postprandial | Difference between groups in postprandial interleukin-6 in response to a mixed meal tolerance test. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers in blood | Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) between test meals in the characterization phase of the study. | 6-hour meal test |
| Appetite |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-hour meal test and 6 week intervention |
| Responsivness to diet |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rikard Landberg, PhD | Contact | +46723509386 | rikard.landberg@chalmers.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University and Research, Human research unit | Recruiting | Wageningen | Netherlands |
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| OTHER |
| German Cancer Research Center | OTHER |
| University of Copenhagen | OTHER |
| University of Oulu | OTHER |
| University College Dublin | OTHER |
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The dietary intervention of personalized dietary advice vs. general healthy diet will be blinded and matched for delivery of intervention and intensity.
Wherever possible Care providers and researchers conducting the analysis (e.g., nurses drawing blood samples) will be blinded to the allocation of intervention.
| Personalized diet | Other | 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. |
|
Differences in self-reported appetite measured using a visual analogue scale between test meals in the characterization phase of the study.
| 6-hour meal test |
| Gut microbiome | Differences in fecal microbiome between test meals in the characterization phase of the study. | 6-hour meal test |
| Metabolome | Differences in metabolome (plasma, urine and feces) between test meals in the characterization phase of the study. | 6-hour meal test |
| Lipid metabolism | Differences in lipid metabolism between test meals in the characterization phase of the study. | 6-hour meal test |
| Glycemic variability | Differences in glycemic variability across the different meals and the OGTT throughout the characterization phase of the study. | 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. | 6-hour meal test |
| Fecal proteome | Differences in fecal proteome between test meals in the characterization phase of the study. | 6-hour meal test |
| PBMC Transcriptome | Differences in peripheral blood mononuclear cell gene expression between test meals in the characterization phase of the study. | 6-hour meal test |
| PBMC Epigenome | Differences in peripheral blood mononuclear cell epigenome between test meals in the characterization phase of the study. | 6-hour meal test |
| PBMC Immunometabolism | Differences in peripheral blood mononuclear cell immunometabolism between test meals in the characterization phase of the study. | 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. | 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. | 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. | 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. | 6 weeks |
| Fecal proteome | Difference in fecal proteome between personalized diet and general healthy diet in the intervention phase of the study. | 6 weeks |
| Gut microbiome | Difference in fecal microbiome between personalized diet and general healthy diet in the intervention phase of the study. | 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. | 6 weeks |
| Glycemic variability | Differences in glycemic variability between personalized diet and general healthy diet in the intervention phase of the study. | 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. | 6 weeks |
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.
| 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). | 6-hour test meal |
| Gastric passage time | Gastric passage time will be assessed using the blue dye method. | 6-hour meal test and 6 week intervention |
| Department of nutrition, University of Oslo | Recruiting | Oslo | Norway |
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| University of Gothenburg, Department of Internal medicin and Clinical nutrition | Recruiting | Gothenburg | Sweden |
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