NAFLDNCT05842850
Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
A study testing Caloric restriction intervention in people with NAFLD, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
Trial 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%. Read more about this study
- Who is it for?
- Ages 35 to 40 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Caloric restriction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Steno Diabetes Center Aarhus
Aarhus
Julie Julie Bondgaard Løhde, MD, juliebm@biomed.au.dk
- Recruiting
Steno Diabetes Center Copenhagen
Herlev
Charlotte Brøns Brøns, PhD, +45 26129093, charlotte.broens.01@regionh.dk
Allan Vaag Vaag, MD, PhD, allan.arthur.vaag@regionh.dk
About this study
Official title: Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Reversibility and Mechanistic Studies.
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.
Read the detailed description
An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. The investigators furthermore hypothesize, that LBW individuals exhibit ectopic liver fat due to reduced capacity to store fat in the subcutaneous adipose tissue (SAT) depot, and that early detection and subsequent intensive caloric restriction, in middle-aged LBW individuals with overt NAFLD, may represent a targeted and highly efficient way forward to prevent more severe cardiometabolic disease manifestations in LBW subjects.
To further explore the recent findings, the investigators aim to perform an extended nested case-control screening study for NAFLD (now MASLD) in 250 early middle-aged non-obese LBW men and women, and subsequently to conduct a proof-of-principle 4 week low-calorie diet (LCD) intervention study in the subjects with hepatic fat content of or above 5% (MR scan). Individuals identified with MALSD in the screening study will be invited to participate in the reversibility study. The reversibility study includes measures of hepatic fat content (primary outcome) MR, fibroscan, DEXA scan, clinical biochemistry and collection of SAT adipose tissue biopsies and progenitor cells for further studies before and after the LCD intervention. The investigators will provide extended in-depth mechanistic insight into transcriptional, epigenetic as well as functional SAT and preadipocyte perturbations underlying impaired SAT expandability in individuals with and without MASLD studied before and after different dietary interventions including LCD and high carbohydrate overfeeding.
- Conditions
- NAFLD
- Being tested
- Caloric restriction intervention, No intervention
- Keywords
- Adipose tissue biology, Caloric restriction, Insulin resistance, Energy expenditure, Insulin secretion
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restriction interventionBehavioural
Also called No intervention
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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| individuals with MASLD | Experimental | individuals with MASLD Receives: Behavioral: Caloric restriction intervention; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
Validation by Magnetic resonance spectroscopy (MRS)
Measured: Change from baseline in liver fat content at 4 weeks
Liver fat content
Liver elastography (FibroScan)
Measured: Change from baseline in liver fat content at 4 weeks
Secondary outcomes (2)
Liver stiffness
Liver elastography (FibroScan)
Measured: Baseline and after 4 weeks
Body composition
DEXA scan
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Lund University
- Responsible party
- Principal investigator, Charlotte Brøns, Steno Diabetes Center Copenhagen
- Investigators
- Charlotte Brøns, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842850
- Sponsor's protocol ID
- NAFLD reversibility
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed to share according to GDPR
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Reversibility and Mechanistic Studies.
- ClinicalTrials.gov ID
- NCT05842850
- Acronym / sponsor ID
- NAFLD reversibility
- Conditions
- NAFLD
- Keywords
- Adipose tissue biology, Caloric restriction, Insulin resistance, Energy expenditure, Insulin secretion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Lund University
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. The investigators furthermore hypothesize, that LBW individuals exhibit ectopic liver fat due to reduced capacity to store fat in the subcutaneous adipose tissue (SAT) depot, and that early detection and subsequent intensive caloric restriction, in middle-aged LBW individuals with overt NAFLD, may represent a targeted and highly efficient way forward to prevent more severe cardiometabolic disease manifestations in LBW subjects.
To further explore the recent findings, the investigators aim to perform an extended nested case-control screening study for NAFLD (now MASLD) in 250 early middle-aged non-obese LBW men and women, and subsequently to conduct a proof-of-principle 4 week low-calorie diet (LCD) intervention study in the subjects with hepatic fat content of or above 5% (MR scan). Individuals identified with MALSD in the screening study will be invited to participate in the reversibility study. The reversibility study includes measures of hepatic fat content (primary outcome) MR, fibroscan, DEXA scan, clinical biochemistry and collection of SAT adipose tissue biopsies and progenitor cells for further studies before and after the LCD intervention. The investigators will provide extended in-depth mechanistic insight into transcriptional, epigenetic as well as functional SAT and preadipocyte perturbations underlying impaired SAT expandability in individuals with and without MASLD studied before and after different dietary interventions including LCD and high carbohydrate overfeeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| individuals with MASLD | Experimental | Behavioral: Caloric restriction intervention, Other: No interventionindividuals with MASLD |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric restriction interventionAlso: No interventionThe 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. | Behavioural | individuals with MASLD |
| No interventionNo intervention | Other | individuals with MASLD |
Primary outcome
Liver fat content
Time frame: Change from baseline in liver fat content at 4 weeks
Validation by Magnetic resonance spectroscopy (MRS)
Liver fat content
Time frame: Change from baseline in liver fat content at 4 weeks
Liver elastography (FibroScan)
2 secondary outcomes
Liver stiffness
Time frame: Baseline and after 4 weeks
Body composition
Time frame: Baseline and after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. not allowed to share according to GDPR
Related trials for NAFLD
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Brøns, PhD principal investigator
Steno Diabetes Center Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction intervention in people with NAFLD, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Brøns, PhD (+4526129093, charlotte.broens.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content (time frame: Change from baseline in liver fat content at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.