NAFLDFixedCarbNCT05643521
The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
A study testing Dietary composition of macronutrients and calories in people with NAFLD and Overweight and Obesity, run by Hvidovre University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- Dietary composition of macronutrients and calories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
About this study
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.
- Conditions
- NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes
- Being tested
- Dietary composition of macronutrients and calories
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Overweight, Obesity, Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary composition of macronutrients and caloriesOther
Carbohydrate restriction
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Experimental | 2 days of eucaloric control diet prior to MRS estimating liver fat (control arm) Receives: Other: Dietary composition of macronutrients and calories |
| Hypocaloric low carbohydrate | Experimental | 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. Receives: Other: Dietary composition of macronutrients and calories |
| Eucaloric low carbohydrate | Experimental | 2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday. Receives: Other: Dietary composition of macronutrients and calories |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 2 days completion of dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Randomized diet intervention study in a cross over design
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Nutrition Exercise and sports Copenhagen University
- Responsible party
- Principal investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643521
- Sponsor's protocol ID
- FixedCarb - H-22035189
- Acronym
- FixedCarb
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
- ClinicalTrials.gov ID
- NCT05643521
- Acronym / sponsor ID
- FixedCarb / FixedCarb - H-22035189
- Conditions
- NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Nutrition Exercise and sports Copenhagen University
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 8 Dec 2022 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover Assignment Randomized diet intervention study in a cross over design
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Experimental | Other: Dietary composition of macronutrients and calories2 days of eucaloric control diet prior to MRS estimating liver fat (control arm) |
| Hypocaloric low carbohydrate | Experimental | Other: Dietary composition of macronutrients and calories2 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. |
| Eucaloric low carbohydrate | Experimental | Other: Dietary composition of macronutrients and calories2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Dietary composition of macronutrients and caloriesCarbohydrate restriction | Other | Control Arm, Eucaloric low carbohydrate, Hypocaloric low carbohydrate |
Primary outcome
The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
Time frame: After 2 days completion of dietary intervention
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary composition of macronutrients and calories in people with NAFLD and Overweight and Obesity, run by Hvidovre University Hospital.
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 9 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content. (time frame: After 2 days completion of dietary intervention). 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 8 Dec 2022.