Hepatic Fat ContentNCT03680248
Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods
A study testing Fat, Fasting and Fat+Glucose in people with Hepatic Fat Content, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
The first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (<5% of fat) and in non-diabetic subjects with an increased HFC (>5% of fat). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Fat Content
- What is being tested?
- Fat, Fasting and Fat+Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCzechia
- Study dates
- 26 Apr 2016to Dec 2019
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal response to oral glucose tolerance test
- normal glycated hemoglobin
- normal aspartate aminotransferase (AST)
- normal alanine aminotransferase (ALT)
Who cannot join
- BMI > 30 kg/m2
- use of pharmacological agents affecting insulin sensitivity
- use of pharmacological agents affecting lipid metabolism
- inability to undergo 1H-MRS examination
Trial locations and contacts
1 site in 1 country.
About this study
The first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (<5% of fat) and in non-diabetic subjects with an increased HFC (>5% of fat). Furthermore, the other objective of the study is to determine whether the response of HFC to a high-fat load is affected by coadministration of glucose or fructose.
Read the detailed description
The epidemic of non-alcoholic fatty liver disease (NAFLD) is becoming a major challenge faced by health system worldwide. The hepatic fat comes from the major sources - non-esterified fatty acids (NEFA) released from adipose tissue, dietary fat and de novo lipogenesis. Fat accumulation in the liver then occurs when triglycerides (TG) that are formed are not rapidly enough oxidized or secreted from the liver in very low density lipoproteins (VLDL). It can be hypothesized that the capacity of the liver to eliminate TG can be overcome after high load of dietary fat. High-fat load should induce an immediate accumulation of hepatic fat that could be detected using 1H magnetic resonance spectroscopy (1H-MRS). The accumulation of liver fat can be also affected by coadministration of simple carbohydrates - glucose and fructose. The administration of these carbohydrates can have a pronounced impact on the availability of particular sources of hepatic fat.
- Conditions
- Hepatic Fat Content
- Being tested
- Fat, Fasting, Fat+Glucose, Glucose, Fat+Fructose
- Keywords
- hepatic fat content, dietary fat, glucose, fructose, non-esterified fatty acid, triglyceride, insulin, postprandial period
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FatDietary supplement
Subjects will consume dairy cream (150 g of fat) at time 0 hours.
FastingDietary supplement
Subjects will fast throughout the experiment.
Fat+GlucoseDietary supplement
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.
GlucoseDietary supplement
Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.
Fat+FructoseDietary supplement
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.
FructoseDietary supplement
Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects, Fat | Experimental | non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load intervention Receives: Dietary Supplement: Fat |
| Steatosis, Fat | Experimental | non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load intervention Receives: Dietary Supplement: Fat |
| Healthy subjects, Fasting | Other | non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fasting Receives: Dietary Supplement: Fasting |
| Steatosis, Fasting | Other | non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fasting Receives: Dietary Supplement: Fasting |
| Healthy subjects, Fat+Glucose | Experimental | non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + glucose administration Receives: Dietary Supplement: Fat+Glucose |
| Steatosis, Fat+Glucose | Experimental | non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + glucose administration Receives: Dietary Supplement: Fat+Glucose |
| Healthy subjects, Glucose | Experimental | non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - glucose administration Receives: Dietary Supplement: Glucose |
| Steatosis, Glucose | Experimental | non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - glucose administration Receives: Dietary Supplement: Glucose |
| Healthy subjects, Fat+Fructose | Experimental | non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + fructose administration Receives: Dietary Supplement: Fat+Fructose |
| Steatosis, Fat+Fructose | Experimental | non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + fructose administration Receives: Dietary Supplement: Fat+Fructose |
| Healthy subjects, Fructose | Experimental | non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fructose administration Receives: Dietary Supplement: Fructose |
| Steatosis, Fructose | Experimental | non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fructose administration Receives: Dietary Supplement: Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fat content
Change in hepatic fat content as determined by proton magnetic resonance spectroscopy (%) between 0 and 6 hours
Measured: Before time 0 hour, 3 hours, 6 hours
Secondary outcomes (5)
TG
Plasma triglyceride concentration
Measured: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
NEFA
Plasma non-esterified fatty-acid concentration
Measured: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Glucose
Plasma glucose concentration
Measured: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Insulin
Plasma insulin concentration
Measured: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Glucagon
Plasma glucagon concentration
Measured: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start26 Apr 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic Fat ContentStudies 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
- Single group
- Model description
- 10 non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) and 10 non-obese non-diabetic subjects with increased hepatic fat content (more than 5% of hepatic fat) will undergo series of six experiments - changes of liver fat content will be measured at time 0, 3 and 6 hours after specific dietary interventions
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jan Kovar, Institute for Clinical and Experimental Medicine
- Investigators
- Milan Hajek, DSc, Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680248
- Sponsor's protocol ID
- G285
- Status last verified
- Jun 2020
- First submitted
- 4 Sep 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dusilova T, Kovar J, Drobny M, Sedivy P, Dezortova M, Poledne R, Zemankova K, Hajek M. Different acute effects of fructose and glucose administration on hepatic fat content. Am J Clin Nutr. 2019 Jun 1;109(6):1519-1526. doi: 10.1093/ajcn/nqy386.
PubMed 31136656
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods
- ClinicalTrials.gov ID
- NCT03680248
- Acronym / sponsor ID
- G285
- Conditions
- Hepatic Fat Content
- Keywords
- hepatic fat content, dietary fat, glucose, fructose, non-esterified fatty acid, triglyceride, insulin, postprandial period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 21 Sep 2018 (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 first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (<5% of fat) and in non-diabetic subjects with an increased HFC (>5% of fat). Furthermore, the other objective of the study is to determine whether the response of HFC to a high-fat load is affected by coadministration of glucose or fructose.
Detailed description
The epidemic of non-alcoholic fatty liver disease (NAFLD) is becoming a major challenge faced by health system worldwide. The hepatic fat comes from the major sources - non-esterified fatty acids (NEFA) released from adipose tissue, dietary fat and de novo lipogenesis. Fat accumulation in the liver then occurs when triglycerides (TG) that are formed are not rapidly enough oxidized or secreted from the liver in very low density lipoproteins (VLDL). It can be hypothesized that the capacity of the liver to eliminate TG can be overcome after high load of dietary fat. High-fat load should induce an immediate accumulation of hepatic fat that could be detected using 1H magnetic resonance spectroscopy (1H-MRS). The accumulation of liver fat can be also affected by coadministration of simple carbohydrates - glucose and fructose. The administration of these carbohydrates can have a pronounced impact on the availability of particular sources of hepatic fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- 10 non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) and 10 non-obese non-diabetic subjects with increased hepatic fat content (more than 5% of hepatic fat) will undergo series of six experiments - changes of liver fat content will be measured at time 0, 3 and 6 hours after specific dietary interventions
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects, Fat | Experimental | Dietary Supplement: Fatnon-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load intervention |
| Steatosis, Fat | Experimental | Dietary Supplement: Fatnon-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load intervention |
| Healthy subjects, Fasting | Other | Dietary Supplement: Fastingnon-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fasting |
| Steatosis, Fasting | Other | Dietary Supplement: Fastingnon-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fasting |
| Healthy subjects, Fat+Glucose | Experimental | Dietary Supplement: Fat+Glucosenon-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + glucose administration |
| Steatosis, Fat+Glucose | Experimental | Dietary Supplement: Fat+Glucosenon-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + glucose administration |
| Healthy subjects, Glucose | Experimental | Dietary Supplement: Glucosenon-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - glucose administration |
| Steatosis, Glucose | Experimental | Dietary Supplement: Glucosenon-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - glucose administration |
| Healthy subjects, Fat+Fructose | Experimental | Dietary Supplement: Fat+Fructosenon-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + fructose administration |
| Steatosis, Fat+Fructose | Experimental | Dietary Supplement: Fat+Fructosenon-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + fructose administration |
| Healthy subjects, Fructose | Experimental | Dietary Supplement: Fructosenon-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fructose administration |
| Steatosis, Fructose | Experimental | Dietary Supplement: Fructosenon-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fructose administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- normal response to oral glucose tolerance test
- normal glycated hemoglobin
- normal aspartate aminotransferase (AST)
- normal alanine aminotransferase (ALT)
Key exclusion criteria (4 listed)
- BMI > 30 kg/m2
- use of pharmacological agents affecting insulin sensitivity
- use of pharmacological agents affecting lipid metabolism
- inability to undergo 1H-MRS examination
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 |
|---|---|---|
| FatSubjects will consume dairy cream (150 g of fat) at time 0 hours. | Dietary supplement | Healthy subjects, Fat, Steatosis, Fat |
| FastingSubjects will fast throughout the experiment. | Dietary supplement | Healthy subjects, Fasting, Steatosis, Fasting |
| Fat+GlucoseSubjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose. | Dietary supplement | Healthy subjects, Fat+Glucose, Steatosis, Fat+Glucose |
| GlucoseSubjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours. | Dietary supplement | Healthy subjects, Glucose, Steatosis, Glucose |
| Fat+FructoseSubjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose. | Dietary supplement | Healthy subjects, Fat+Fructose, Steatosis, Fat+Fructose |
| FructoseSubjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours. | Dietary supplement | Healthy subjects, Fructose, Steatosis, Fructose |
Primary outcome
Hepatic fat content
Time frame: Before time 0 hour, 3 hours, 6 hours
Change in hepatic fat content as determined by proton magnetic resonance spectroscopy (%) between 0 and 6 hours
5 secondary outcomes
TG
Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
NEFA
Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Glucose
Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Insulin
Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Glucagon
Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 31136656Dusilova T, Kovar J, Drobny M, Sedivy P, Dezortova M, Poledne R, Zemankova K, Hajek M. Different acute effects of fructose and glucose administration on hepatic fat content. Am J Clin Nutr. 2019 Jun 1;109(6):1519-1526. doi: 10.1093/ajcn/nqy386.
- Individual participant dataSharing planned: No
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.
Milan Hajek, DSc principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat, Fasting and Fat+Glucose in people with Hepatic Fat Content, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 4 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: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hepatic fat content (time frame: Before time 0 hour, 3 hours, 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680248, which also lists 1 linked publication.
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 16 Jun 2020.