Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes
NCT ID: NCT04527965
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2020-08-11
2022-12-20
Brief Summary
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Detailed Description
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* Investigate the effects of the diets on liver fat content (primary aim)
* Investigate the effects of the diets on pancreatic fat, visceral fat, lean tissue, glycemic and lipid control
* Investigate the effects of the diets on plasma markers of de novo lipogenesis (DNL) and desaturation (i.e. stearoyl-Coenzyme desaturase 1, SCD-1) as well as on hepatic DNL using MRI spectroscopy
* Investigate gene-diet interactions, especially if common gene variants (e.g. in PNPLA3) known to increase liver fat and dyslipidemia, may modify the dietary effects.
* Perform lipidomic analyses to identify potential mechanistic pathways that may associate with diet-induced changes in liver fat, pancreatic fat, visceral fat, insulin sensitivity, dyslipidemia or DNL
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Customized diet to reduce liver fat
Ad libitum diet high in plant-derived PUFA and lower in carbohydrates
Customized diet to reduce liver fat
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
Healthy Nordic diet
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
Healthy Nordic diet
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
Ad libitum diet in accordance with the Nordic Nutrition Recommendations
Control
Ad libitum diet in accordance with the Nordic Nutrition Recommendations
Key foods are provided
Interventions
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Customized diet to reduce liver fat
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
Healthy Nordic diet
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
Ad libitum diet in accordance with the Nordic Nutrition Recommendations
Key foods are provided
Eligibility Criteria
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Inclusion Criteria
* 30-75 years
* BMI 25-40
* T2D (duration ≤10 years, no insulin treatment) or prediabetes (ADA definition 2019) without diagnosed cardiovascular disease (CVD) during the last 2 years (e.g. myocardial infarction, stroke or angina pectoris)
Exclusion Criteria
* Alcohol intake \>20 g/day
* Unwillingness to follow a new prescribed diet for 1 year
* Diet-induced weight loss (≥10%) the preceding 3 months of screening
* Malignant disease
* Severe kidney and liver disease
* Heart failure or other severe CVD
* claustrophobia or metal parts in the body (MRI)
30 Years
75 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Ulf Risérus, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Lars Lind, MD
Role: STUDY_DIRECTOR
Uppsala University
Locations
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Uppsala univeristy hospital
Uppsala, , Sweden
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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NAFLDiet
Identifier Type: -
Identifier Source: org_study_id