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The overall aim of this study is to investigate the long-term impact of a customized diet aimed at reducing liver fat specifically and a healthy Nordic diet on ectopic fat (liver, pancreatic and visceral) and cardiometabolic risk in individuals with prediabetes and type 2 diabetes (T2D).
Randomized controlled studies investigating the impact of replacing dietary carbohydrates with polyunsaturated fat (PUFA) on liver fat content and cardiometabolic risk in individuals with prediabetes and T2D are lacking. Also, the effects of a Healthy Nordic Diet on liver fat content and glycemic control have not be investigated. This study therefore aims to:
Our hypothesis is that a customized diet will effectively reduce liver fat through suppression of hepatic DNL and SCD-1 activity, and thereby improve atherogenic dyslipidemia, insulin resistance and hyperglycemia in individuals with prediabetes and T2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized diet to reduce liver fat | Experimental | Ad libitum diet high in plant-derived PUFA and lower in carbohydrates |
|
| Healthy Nordic diet | Experimental | Ad libitum diet, based on Nordic foods, higher in carbohydrates (high fiber/low GI) and lower in fat but rich in monounsaturated fatty acids (MUFA) and PUFA |
|
| Control | Active Comparator | Ad libitum diet in accordance with the Nordic Nutrition Recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customized diet to reduce liver fat | Other | Ad libitum diet high in plant-derived PUFA and lower in carbohydrates Carbohydrates: 30 E% Fat: 50 E% (PUFA 10-15 E%) Protein: 20 E% Key foods are provided |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group changes in liver fat content between baseline and month 12 | Assessed by magnetic resonance imaging (MRI) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group changes in visceral adipose tissue mass between baseline and month 12 | Assessed by magnetic resonance imaging (MRI) | 12 months |
| Between-group changes in lean tissue mass between baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group changes in plasma-derived fatty acids and fatty acid ratios in the lipogenic pathway between baseline and month 12 | Assessed by gas chromatography (GC) | 12 months |
| Between-group changes in imaging-derived fatty acids and fatty acid ratios in the lipogenic pathway between baseline and month 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Risérus, PhD | Uppsala University | Principal Investigator |
| Lars Lind, MD | Uppsala University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala univeristy hospital | Uppsala | 75185 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2021 | May 12, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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Parallel Assignment
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| Healthy Nordic diet | Other | Ad libitum diet, based on Nordic foods, high in carbohydrates (high fiber/low GI) and lower in fat Carbohydrates: 50-55 E% Fat: 25-30 E% (PUFA 5-7.5 E%) Protein: 20 E% Key foods are provided |
|
| Control | Other | Ad libitum diet in accordance with the Nordic Nutrition Recommendations Key foods are provided |
|
Assessed by magnetic resonance imaging (MRI)
| 12 months |
| Between-group changes in total body fat mass between baseline and month 12 | Assessed by magnetic resonance imaging (MRI) | 12 months |
| Between-group changes in body weight between baseline and month 12 | Assessed by using a Tanita bioelectrical impedance analysis (BIA) scale | 12 months |
| Between-group changes in glycated hemoglobin (HbA1c) between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in fasting plasma glucose between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in fasting serum insulin between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in systolic blood pressure between baseline and month 12 | Assessed by using an automated blood pressure monitor | 12 months |
| Between-group changes in diastolic blood pressure between baseline and month 12 | Assessed by using an automated blood pressure monitor | 12 months |
| Between-group changes in plasma lipids (total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol, apoB and apoA1) between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in circulating inflammatory markers (CRP, Tumor Necrosis Factor Alpha-receptor 1 and 2, Interleukin-1 receptor antagonist, Fibroblast growth factor 21) between baseline and month 12 | Assessed by routine clinical chemistry and ELISA | 12 months |
| Between-group changes in pancreatic fat between baseline and month 12 | Assessed by magnetic resonance imaging (MRI) | 12 months |
| Between-group changes in flow-mediated dilation (FMD) between baseline and month 12 | Assessed by ultrasound in approximately half of the study population (n=75) | 12 months |
| Between-group changes in pulse-wave velocity (PWV) between baseline and month 12 | Assessed by ultrasound in approximately half of the study population (n=75) | 12 months |
| Between-group values in FMD at month 12 | Assessed by ultrasound in the whole population (n=150) | 12 months |
| Between-group values in PWV at month 12 | Assessed by ultrasound in the whole population (n=150) | 12 months |
| Between-group changes in liver fat in prespecified subgroups and in individuals with low respectively high dietary compliance based on dietary and lipogenic biomarkers changes between baseline and month 12 | Assessed by magnetic resonance imaging (MRI) | 12 months |
| Between-group changes in HbA1c in prespecified subgroups and in individuals with low respectively high dietary compliance based on dietary and lipogenic biomarkers changes between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in blood lipids in prespecified subgroups and in individuals with low respectively high dietary compliance based on dietary and lipogenic biomarkers changes between baseline and month 12 | Assessed by routine clinical chemistry | 12 months |
| Between-group changes in FIB-4 between baseline and month 12 | Assessed by routine clinical chemistry in combination with age | 12 months |
Assessed by proton magnetic resonance spectroscopy (1 H-MRS) |
| 12 months |
| Between-group changes in plasma lipids (ceramides) using a targeted lipidomic approach between baseline and month 12 | Lipids are measured using ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) | 12 months |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |