NCT05842850

Brief Summary

The investigators will conduct a proof-of-principle 4-weeks low-calorie diet (LCD) intervention study in low birth weight (LBW) subjects and normal birth weight (NBW) controls with documented (MR scan) liver fat content equal to or above 5%. The investigators will provide extended in-depth mechanistic insight into the role of impaired subcutaneous adipose tissue (SAT) expandability in ectopic fat deposition before and after LCD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jan 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress65%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

April 11, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 11, 2023

Last Update Submit

April 28, 2026

Conditions

NAFLD

Keywords

Adipose tissue biologyCaloric restrictionInsulin resistanceEnergy expenditureInsulin secretion

Outcome Measures

Primary Outcomes (2)

  • Liver fat content

    Validation by Magnetic resonance spectroscopy (MRS)

    Change from baseline in liver fat content at 4 weeks

  • Liver fat content

    Liver elastography (FibroScan)

    Change from baseline in liver fat content at 4 weeks

Secondary Outcomes (2)

  • Liver stiffness

    Baseline and after 4 weeks

  • Body composition

    Baseline and after 4 weeks

Other Outcomes (8)

  • Adipocyte size

    Baseline and after 4 weeks

  • Collagen content

    Baseline and after 4 weeks

  • Transcriptomics

    Baseline and after 4 weeks

  • +5 more other outcomes

Study Arms (1)

individuals with MASLD

EXPERIMENTAL

individuals with MASLD

Behavioral: Caloric restriction interventionOther: No intervention

Interventions

Caloric restriction interventionBEHAVIORAL

The intervention consist of 4-weeks low calories diet (LCD) using total meal replacement from NUPO. A dietician will guide the participants an ensure well-being during the intervention.

Also known as: No intervention
individuals with MASLD
No interventionOTHER

No intervention

individuals with MASLD

Eligibility Criteria

Age35 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)

You may not qualify if:

  • BMI\<18.5 and BMI\>30 kg/m2
  • Family history of diabetes (siblings, parent, and grandparents)
  • Disease/medication known to affect primary outcome
  • Self-reported high physical activity level
  • Alcohol intake above general recommendations.
  • Metabolic/liver disease
  • Weight gain/loss of \>3 kg within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center Aarhus

Aarhus, Denmark

RECRUITING

Steno Diabetes Center Copenhagen

Herlev, Denmark

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseInsulin Resistance

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Charlotte Brøns, PhD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Brøns, PhD

CONTACT

+4526129093charlotte.broens.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants with MASLD will be recruited from a nested case-control (NAFLD) screening study. Participants will be examined at baseline and after 4-weeks low-calorie diet (LCD). Participants will be guided to a dietician ensuring overall week-being. Participant will be examined by MR and DEXA scans, Fibroscan, blood samples for clinical biochemistry including liver enzymes. A fasting subcutaneous adipose tissue (SAT) biopsy will be obtained and progenitor cell collected for later studies.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 6, 2023

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

not allowed to share according to GDPR

Locations

DK(2)