NCT04527965

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

August 5, 2020

Last Update Submit

December 21, 2022

Conditions

NAFLDDiabetes Mellitus, Type 2PreDiabetes

Keywords

NAFLDDiabetes Mellitus, Type 2PrediabetesFatty acidsDietLipogenesisCardiometabolic risk

Outcome Measures

Primary Outcomes (1)

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

    Assessed by magnetic resonance imaging (MRI)

    12 months

Secondary Outcomes (21)

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

    12 months

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

    12 months

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

    12 months

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

    12 months

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

    12 months

  • +16 more secondary outcomes

Other Outcomes (3)

  • Between-group changes in plasma-derived fatty acids and fatty acid ratios in the lipogenic pathway between baseline and month 12

    12 months

  • Between-group changes in imaging-derived fatty acids and fatty acid ratios in the lipogenic pathway between baseline and month 12

    12 months

  • Between-group changes in plasma lipids (ceramides) using a targeted lipidomic approach between baseline and month 12

    12 months

Study Arms (3)

Customized diet to reduce liver fat

EXPERIMENTAL

Ad libitum diet high in plant-derived PUFA and lower in carbohydrates

Other: Customized diet to reduce liver fat

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

Other: Healthy Nordic diet

Control

ACTIVE COMPARATOR

Ad libitum diet in accordance with the Nordic Nutrition Recommendations

Other: Control

Interventions

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

Customized diet to reduce liver fat
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

Healthy Nordic diet
ControlOTHER

Ad libitum diet in accordance with the Nordic Nutrition Recommendations Key foods are provided

Control

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala univeristy hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ulf Risérus, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

  • Lars Lind, MD

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 27, 2020

Study Start

August 11, 2020

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations

SE(1)