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NAFLDNAFLDietNCT04527965

Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes

A study testing Customized diet to reduce liver fat and Healthy Nordic diet in people with NAFLD and Diabetes Mellitus, Type 2, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
NAFLD, Diabetes Mellitus, Type 2, PreDiabetes
What is being tested?
Customized diet to reduce liver fat and Healthy Nordic diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSweden
Study dates
11 Aug 2020to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women
  • 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)

Who cannot join

  • BMI >40
  • 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)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala univeristy hospital

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes: a Randomized Study (NAFLDiet)

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).

Read the detailed description

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:

  • 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.

Being tested
Customized diet to reduce liver fat, Healthy Nordic diet, Control
Keywords
NAFLD, Diabetes Mellitus, Type 2, Prediabetes, Fatty acids, Diet, Lipogenesis, Cardiometabolic risk
Medical subject headings
Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Customized diet to reduce liver fatOther

    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 dietOther

    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

  • ControlOther

    Ad libitum diet in accordance with the Nordic Nutrition Recommendations

    Key foods are provided

Study groups in NCT04527965
Study groupRoleWhat they receive
Customized diet to reduce liver fatExperimentalAd libitum diet high in plant-derived PUFA and lower in carbohydrates
Receives: Other: Customized diet to reduce liver fat
Healthy Nordic dietExperimentalAd 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
Receives: Other: Healthy Nordic diet
ControlActive comparatorAd libitum diet in accordance with the Nordic Nutrition Recommendations
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-group changes in liver fat content between baseline and month 12

    Assessed by magnetic resonance imaging (MRI)

    Measured: 12 months

Secondary outcomes (21)

  1. Between-group changes in visceral adipose tissue mass between baseline and month 12

    Assessed by magnetic resonance imaging (MRI)

    Measured: 12 months

  2. Between-group changes in lean tissue mass between baseline and month 12

    Assessed by magnetic resonance imaging (MRI)

    Measured: 12 months

  3. Between-group changes in total body fat mass between baseline and month 12

    Assessed by magnetic resonance imaging (MRI)

    Measured: 12 months

  4. Between-group changes in body weight between baseline and month 12

    Assessed by using a Tanita bioelectrical impedance analysis (BIA) scale

    Measured: 12 months

  5. Between-group changes in glycated hemoglobin (HbA1c) between baseline and month 12

    Assessed by routine clinical chemistry

    Measured: 12 months

  6. Between-group changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) between baseline and month 12

    Assessed by routine clinical chemistry

    Measured: 12 months

  7. Between-group changes in fasting plasma glucose between baseline and month 12

    Assessed by routine clinical chemistry

    Measured: 12 months

  8. Between-group changes in fasting serum insulin between baseline and month 12

    Assessed by routine clinical chemistry

    Measured: 12 months

  9. Between-group changes in systolic blood pressure between baseline and month 12

    Assessed by using an automated blood pressure monitor

    Measured: 12 months

  10. Between-group changes in diastolic blood pressure between baseline and month 12

    Assessed by using an automated blood pressure monitor

    Measured: 12 months

  11. 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

    Measured: 12 months

  12. 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

    Measured: 12 months

  13. Between-group changes in pancreatic fat between baseline and month 12

    Assessed by magnetic resonance imaging (MRI)

    Measured: 12 months

  14. 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)

    Measured: 12 months

  15. 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)

    Measured: 12 months

  16. Between-group values in FMD at month 12

    Assessed by ultrasound in the whole population (n=150)

    Measured: 12 months

  17. Between-group values in PWV at month 12

    Assessed by ultrasound in the whole population (n=150)

    Measured: 12 months

  18. 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)

    Measured: 12 months

  19. 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

    Measured: 12 months

  20. 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

    Measured: 12 months

  21. Between-group changes in FIB-4 between baseline and month 12

    Assessed by routine clinical chemistry in combination with age

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start11 Aug 2020
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04527965
Sponsor's protocol ID
NAFLDiet
Acronym
NAFLDiet
Status last verified
Dec 2022
First submitted
5 Aug 2020
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Customized diet to reduce liver fat and Healthy Nordic diet in people with NAFLD and Diabetes Mellitus, Type 2, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-group changes in liver fat content between baseline and month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04527965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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