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Status unknownNCT05643521FixedCarbUpdated Dec 8, 2022

The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals

An interventional study of Dietary composition of macronutrients and calories in NAFLD, Overweight and Obesity and Metabolic Syndrome, sponsored by Hvidovre University Hospital. Status unknown. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

The primary aim of this study is to investigate the acute changes in liver fat content in response to a fixed carbohydrate restriction (i.e. intake of 60g/day or 70g/day for women and men, respectively) in individuals with obesity. This will be performed both as 2 days of very low calorie diet (500 and 600 kcal/day for women and men, respectively) and 2 days of eucaloric low carbohydrate diet.

02

Conditions studied

  • NAFLD
  • Overweight and Obesity
  • Metabolic Syndrome
  • Diabetes
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 14 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Browse Hvidovre University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men (30-75 years) and postmenopausal women 45-75 years old
  • Hba1c \<48 mmol/mol without antidiabetic treatment
  • Obese (BMI 27-40 kg/m2)
  • Non smokers

Exclusion criteria

Exclusion Criteria:

  • Anemia (hemoglobin \<8 mmol/L for men and \<7 mmol/L for women)
  • TSH outside reference range
  • Medication known to influence glucose metabolism or appetite regulation
  • Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
  • Food allergies (including lactose and gluten intolerance), vegetarian/vegan diet or following specific dietary plans
  • Alcohol consumptions >84/168 g/week (women/men)
  • Strenuous activity level > 120 minutes per week
  • >5 kg weight loss within the last three months or previous bariatric surgery
  • High risk of fibrosis of the liver (estimated by FIB4 score > 3,25)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Control Arm

    2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)

    Other: Dietary composition of macronutrients and calories

  • Experimental
    Hypocaloric low carbohydrate

    2 days of eucaloric control diet + 2 days of hypocaloric (500-600 kcal m/f) low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.

    Other: Dietary composition of macronutrients and calories

  • Experimental
    Eucaloric low carbohydrate

    2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.

    Other: Dietary composition of macronutrients and calories

Interventions

  • OtherDietary composition of macronutrients and calories

    Carbohydrate restriction

06

What researchers measure

Primary outcomes

  1. The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.

    We will compare MRS of liver TG after each of the two interventions (2 days of VLCD or 2 days of LC) with MRS liver TG obtained after 2 days of eucaloric conventional diet.

    Time frame: After 2 days completion of dietary intervention

Secondary outcomes

  1. Secondary outcomes are fasting and postprandial plasma glucose, insulin, and plasma TG concentrations after 2 days VLCD or LC compared with 2 days of eucaloric conventional diet.

    Time frame: After 2 days completion of dietary intervention

Other outcomes

  1. Explorative outcomes

    Explorative outcomes are the effects of VLCD and LC on subsequent food intake in response to an ad libitum lunch meal.

    Time frame: After 2 days completion of dietary intervention

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2022; primary completion for Nov 2024, 23 months later.

Of 323 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 23 months is close to that.

Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2022
First posted
Dec 8, 2022
StartEst.
Dec 1, 2022
Primary completionEst.
Nov 1, 2024
CompletionEst.
Nov 1, 2024
Last update
Dec 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05643521
Lead sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen, Nutrition Exercise and sports Copenhagen University
Responsible party
Kirstine Nyvold Bojsen-Moeller (Principal investigator, MD, PhD Affiliation: Hvidovre University Hospital, Hvidovre University Hospital) — Principal investigator
First posted
Dec 8, 2022
Start date
Dec 1, 2022 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Dec 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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